recall_number string | recall_type string | firm_name string | product_description string | reason_for_recall string | status string | recall_class null | initiation_date date32 | report_date date32 | distribution_pattern string | product_quantity string | product_ndc string | fei_number string | facility_total_inspections float64 | facility_oai_count float64 | facility_last_classification string | facility_last_inspection date32 | facility_compliance_actions int64 | facility_warning_letters int64 | last_compliance_action_date date32 | preceded_by_oai bool | days_since_last_inspection float64 | failure_category string | failure_subcategory string |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Z-0570-2020 | device | Wright Medical Technology, Inc. | SWANSON FINGER JOINT #1, Part Number 4700001 | The firm discovered a lack of adequate documentation confirming sterility on certain products. | Terminated | null | 2016-11-08 | 2019-12-04 | null | 20 units | null | 3010131759 | 3 | 0 | No Action Indicated (NAI) | 2023-08-09 | 0 | 0 | null | false | -1 | sterility | inadequate documentation |
Z-0030-2020 | device | Baxter Healthcare Corporation | L5C4531 X1 Integrated APD Set with Cassette 3-Prong Sterile, nonpyrogenic fluid path. Sterilized by ethylene oxide. | Potential presence of leaks from the cassettes, which may be present due to an incomplete seal of the sheeting to the cassette. A leaking cassette could lead to contamination of the sterile fluid path with micro-organisms. This may predispose the patient to peritonitis. | Terminated | null | 2018-10-10 | 2019-10-09 | null | 8640 eaches | null | 3007319130 | 4 | 0 | No Action Indicated (NAI) | 2016-01-07 | 0 | 0 | null | false | 0 | sterility | cassette seal leaks |
D-614-2015 | drug | Attix Pharmaceuticals | Dapsone active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada | Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin. | Terminated | null | 2014-11-14 | 2015-04-29 | Nationwide to compounding pharmacies and research organizations. | 5420 grams | null | null | null | null | null | null | 0 | 0 | null | false | null | contamination | penicillin cross-contamination |
Z-0068-2015 | device | Merge Healthcare, Inc. | eFilm Workstation 4.0 and 4.0.1. eFilm Workstation is one of the components of a PACS (Picture Archiving and Communications System). Product Usage: eFilm Workstation is a software application that is used for viewing medical images. eFilm Workstation receives digital images and data from various sources (includi... | There is an issue related to eFilm Workstation versions 4.0 and 4.0.1 when having multiple studies open and utilizing the thumbnail panel to select multiple series from multiple studies may lead to the selection of an incorrect study. | Terminated | null | 2014-08-28 | 2014-10-22 | null | 2,630 | null | 1000116130 | 6 | 1 | No Action Indicated (NAI) | 2016-08-19 | 1 | 1 | 2015-09-30 | false | -1 | software | incorrect study selection |
Z-0350-2019 | device | Cook Medical Incorporated | Zilver 635 Biliary Stent 5mm x 80mm, Catalog Number: ZIB6-80-5.0-80 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree. | The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail. | Terminated | null | 2018-09-25 | 2018-11-07 | null | 9834 total | null | 3005580113 | 1 | 0 | Voluntary Action Indicated (VAI) | 2018-08-23 | 0 | 0 | null | false | 0 | device_malfunction | incorrect deployment instructions |
Z-2718-2020 | device | CareFusion 303, Inc. | Alaris Pump Module Model 8100, a modular infusion pump and monitoring system | Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit and modules, which may result in an infusion that stops with a CHANNEL DISCONNECTED message, and an audio/visual alarm on the PC Unit and an interruption of therapy or monitoring. | Terminated | null | 2020-06-30 | 2020-08-12 | null | 1332354 | null | 3003560006 | 3 | 0 | No Action Indicated (NAI) | 2020-02-05 | 0 | 0 | null | false | 0 | device_malfunction | connector damage risk |
D-1155-2015 | drug | Lincare, Inc. | TPN 3:1, 997 ml with lipids Bags, Qty: 7, Base Formula Dextrose 70%, Travasol 10%, Intralipid 20%, Water for Inj; Electrolytes K Acetate, Na Acetate, KCL, Na Phos, Ca Gluconate, MgSO4, NaCl, Zinc Cl; Vitamins, trace elements and medications Selenium, Copper Cl, Carnitor, Rx Only. United Medical IV Center (Little Rock)... | Lack of Assurance of Sterility: Sterility of product is not assured. | Terminated | null | 2015-05-28 | 2015-07-08 | United States including: Arkansas | 4 Bags | null | 1000307687 | 1 | 0 | No Action Indicated (NAI) | 2011-02-23 | 0 | 0 | null | false | 0 | sterility | lack of sterility assurance |
Z-1424-2015 | device | Nobel Biocare Usa Llc | Replace Select Tapered TiU RP 4.3x11.5mm, Article No. 36107. | A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads. | Terminated | null | 2015-03-09 | 2015-04-22 | null | 32 units | null | 1000125598 | 7 | 0 | No Action Indicated (NAI) | 2025-08-08 | 0 | 0 | null | false | -1 | packaging | sticky substance contamination |
D-0061-2022 | drug | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy | METHYLCOBALAMIN 5000MCG/ML MDV INJ, Rx only, Red Mountain Compounding Rx | Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns | Terminated | null | 2021-08-13 | 2021-11-03 | 494 patients/consumers received prescriptions and are located in AZ, CA FL, MN, MT, TX, and UT. | N/A | null | 3015235235 | 3 | 2 | Voluntary Action Indicated (VAI) | 2022-09-12 | 1 | 1 | 2020-09-10 | false | -1 | sterility | sterility assurance |
Z-2321-2024 | device | Baxter Healthcare Corporation | Volara System. Single Patient Use (SPU) Circuit 5kit for Volara and Single Patient Use (SPU) Circuit kit for Volara. Intermittent positive pressure breathing device. | Potential of the handset plug to disconnect from the nebulizer port on the blue ventilator adapter. The handset plug is required to ensure proper operation and ventilator gas flow. | Ongoing | null | 2024-05-30 | 2024-07-24 | null | 58,220 units | null | 3007319130 | 4 | 0 | No Action Indicated (NAI) | 2016-01-07 | 0 | 0 | null | false | 0 | device_malfunction | handset plug disconnection |
Z-1703-2024 | device | IVOCLAR VIVADENT AG | IPS e.max ZirCAD CER/in. Prime BL1 C17/3- A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758434 | Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration | Ongoing | null | 2024-04-05 | 2024-05-08 | null | 2286 units | null | 3002808636 | 1 | 0 | Voluntary Action Indicated (VAI) | 2016-08-24 | 0 | 0 | null | false | 0 | device_malfunction | cracked blocks |
Z-2410-2021 | device | Versea Diagnostics LLC | Status COVID-19/Flu Rapid Immunoassay for Direct Detection and Differential Diagnosis of SARS-CoV-2, Influenzas Type A, and Type B Antigens Simultaneous qualitative detection and differentiation of nucleocapsid antigen from SARS-CoV-2, influenza A and influenza B directly from nasopharyngeal swab specimens obtained f... | Products may have been distributed to customers other than laboratories certified under the Clinical Laboratory Improvement Amendments as stipulated in the Emergency Use Authorization. | Terminated | null | 2021-07-27 | 2021-09-08 | null | 563,290 in total | null | null | null | null | null | null | 0 | 0 | null | false | null | cGMP | unauthorized distribution |
Z-0066-2021 | device | Medline Industries Inc | Kit Model #650600111, MTO Left Heart St Francis Hosp - PG - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist of any combination of devices from the NAMIC Fluid Management finished good product families and potentially other devices designed and manufactured by original equipment manufacturer... | Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities. | Terminated | null | 2020-09-14 | 2020-10-14 | null | 32 kits | null | 3011243430 | 1 | 0 | No Action Indicated (NAI) | 2024-04-29 | 0 | 0 | null | false | -1 | sterility | non-sterilized kits |
D-1568-2014 | drug | Pharmakon Pharmaceuticals | Atropine Sulfate 0.4 mg/ml Injection, USP, Total Dosage 0.8 mg per 2 mL, 3 mL pre-filled syringe, Rx Only. Pharmakon Pharmaceuticals, Inc., 14450 Getz Road, Noblesville, IN. NDC: 45183-0105-78. | Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol. | Terminated | null | 2014-04-21 | 2014-09-03 | United States: TX, IL, MD, IN | 5 Syringes | null | null | null | null | null | null | 0 | 0 | null | false | null | undeclared_allergen | benzyl alcohol |
D-1057-2017 | drug | PD-Rx Pharmaceuticals, Inc. | Famotidine USP 20 mg, 30 tablets bottle, Rx, PKG By; PD Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 --- NDC 55289-765-30 | Failed Tablet/Capsule Specification: out of specification for tablet weight. | Terminated | null | 2017-07-28 | 2017-08-09 | Nationwide | 100 bottles | null | 1641825 | 3 | 0 | Voluntary Action Indicated (VAI) | 2022-11-10 | 0 | 0 | null | false | -1 | cGMP | tablet weight variance |
Z-1198-2022 | device | Busse Hospital Disposables, Inc. | SS 3.2MM Pellet Insertion Tray Catalog Number: B8110R1 | Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products | Terminated | null | 2022-02-22 | 2022-06-08 | null | 300 units | null | 2433012 | 6 | 0 | Voluntary Action Indicated (VAI) | 2018-04-13 | 0 | 0 | null | false | 0 | cGMP | test method validation |
Z-0703-2026 | device | B Braun Medical Inc | IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV AD.SET W/15 DR 128 IN, EXT SET 9 IN; Catalog Number: 490301. | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | Ongoing | null | 2025-10-29 | 2025-12-03 | null | 31,392 units | null | null | null | null | null | null | 0 | 0 | null | false | null | device_malfunction | backflow and occlusion |
D-1051-2023 | drug | Central Admixture Pharmacy Services Inc | fentaNYL, 5000 mcg/100 mL, (50 mcg/mL), 100 mL Bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-5 | Lack of assurance of sterility: Lack of validation data for sanitization cycles | Terminated | null | 2023-07-17 | 2023-08-09 | Nationwide in the USA | 94 bags | null | 3005292119 | 1 | 0 | Voluntary Action Indicated (VAI) | 2021-05-24 | 0 | 0 | null | false | 0 | sterility | sanitization validation |
Z-0752-2023 | device | GE Medical Systems, LLC | Vivid S5 Ultrasound. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Tr... | Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they can fail or possibly emit smoke, or catch fire. | Ongoing | null | 2022-11-10 | 2022-12-28 | null | 5,649 units | null | 2183553 | 3 | 0 | No Action Indicated (NAI) | 2012-10-11 | 0 | 0 | null | false | 0 | device_malfunction | battery failure hazard |
Z-0364-2018 | device | Boston Scientific Corporation | ALTRUA 2 EL DR Pacemaker | Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers). | Ongoing | null | 2017-12-07 | 2018-01-24 | null | N/A | null | 3010178326 | 1 | 0 | Voluntary Action Indicated (VAI) | 2014-03-20 | 0 | 0 | null | false | 0 | device_malfunction | sensor over-sensing |
Z-1120-2021 | device | Baxter Healthcare Corporation | Gambro Cartridge Blood Transport System for Hemodialysis Blood Set, product code 106289 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems. | complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received. | Ongoing | null | 2020-12-30 | 2021-02-24 | null | 1460 devices | null | 3006472186 | 4 | 0 | Voluntary Action Indicated (VAI) | 2016-11-29 | 0 | 0 | null | false | 0 | device_malfunction | kinked access lines |
Z-0210-2021 | device | ICU Medical, Inc. | 13 IN (33cm) APPX 0.96 ml, PENTAFUSE SMALLBORE SET, NanoClave, 3 MicroClave Clear. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709090245(17)250101(30)50(10)4557533; (01)10887709090245(17)250101(30)50(10)4572968. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provi... | Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike. | Terminated | null | 2020-07-06 | 2020-10-28 | null | Total of all products (Listed #1 thru 101) = 304735 units | null | 2025816 | 2 | 0 | No Action Indicated (NAI) | 2017-07-14 | 0 | 0 | null | false | 0 | device_malfunction | seal defect |
Z-3201-2018 | device | Medtronic Inc. | Contour Plus Link 2.4, Product Catalog Number: MMT-1151SK. wireless blood glucose monitoring system Contour Plus LINK 2.4 wireless blood glucose monitoring system (glucometer, test strips and control solution) is designed for self-testing by persons with diabetes and the monitoring of glucose concentrations for qua... | CONTOUR PLUS LINK 2.4 meter with an incorrect unit of measure was included into meter kits and distributed. This meter contains the incorrect unit of measure mg/dL instead of mmol/L. | Terminated | null | 2018-05-16 | 2018-09-26 | null | 2 | null | 3008786301 | 2 | 0 | No Action Indicated (NAI) | 2015-03-10 | 0 | 0 | null | false | 0 | mislabeling | incorrect unit of measure |
Z-1182-2013 | device | Siemens Medical Solutions USA, Inc | Software correction applies to customers who use the RT Therapist RTT4.2.108 and RT Therapist Connect RTT 4.2.108 on Siemens ARTISTE, ONCOR and PRIMUS systems. ARTISTE, ONCOR and PRIMUS family of linear accelerators are used to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. | Software update to fix multiple safety related issues. | Terminated | null | 2013-04-04 | 2013-05-08 | null | 245 active devices | null | null | null | null | null | null | 0 | 0 | null | false | null | software | safety issue fixes |
Z-2207-2016 | device | Terumo Cardiovascular Systems Corporation | HX2" Temperature Management Systems; The Terumo¿ HX2" Temperature Management System provides temperature control of two independent water circuits that directly controls the temperature of patient blood and cardioplegia solution during cardiovascular surgery. The system consists of a water tank, circulating pumps,... | Terumo Cardiovascular Systems (Terumo CVS) is conducting a voluntary recall of its heater-cooler devices due to the distributor no longer selling the Interchlor sanitizer (Product Code 205) referenced in its heater-cooler cleaning instructions. | Terminated | null | 2016-06-08 | 2016-07-27 | null | 6412 units | null | 3000204839 | 6 | 0 | No Action Indicated (NAI) | 2024-02-16 | 0 | 0 | null | false | -1 | device_malfunction | sanitizer unavailability |
Z-2328-2015 | device | Philips Electronics North America Corporation | Philips HeartStart XL+ Defibrillator/Monitor Product Usage: The HeartStart XL+ is intended for use in a hospital setting by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced life support or defibrillation. When operating as a semi-automatic ... | Multiple software and hardware issues with device that can affect its function. | Terminated | null | 2015-06-05 | 2015-08-12 | null | 13,168 devices | null | null | null | null | null | null | 0 | 0 | null | false | null | device_malfunction | software and hardware issues |
Z-0219-2019 | device | Nakanishi Inc. | Surgical Handpiece, Model: SGS-E, Order Code: H084, Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant use: drilling and tapping the maxilla and mandible. | Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions of manual cleaning and specific parameters for autoclave sterilization . The previous operation manuals associated with the SGS/SGA products must be replaced by new operation manuals. | Terminated | null | 2018-06-01 | 2018-10-31 | null | 12 | null | null | null | null | null | null | 0 | 0 | null | false | null | software | updated sterilization instructions |
Z-2828-2016 | device | ICU Medical, Inc. | Monitoring Kit with TP4, 30 ml Squeeze Flush Device, 10 cc Contamination Syringe and Needleless Valve, Item No. 46112-65 Product Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes ... | ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. | Terminated | null | 2016-08-10 | 2016-09-21 | null | 20 units | null | 1713468 | 7 | 0 | No Action Indicated (NAI) | 2024-09-26 | 0 | 0 | null | false | -1 | device_malfunction | potential leak |
Z-1391-2019 | device | Boston Scientific Corporation | AURIGA XL 4007 BRAZIL SYSTEM Model: M0068FS4007B0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a fiber optic delivery system is intended to be used in surgical procedures such as open, laparoscopic and endoscopic, to perform incision, excision, resection, ablation, va... | Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue in the mechanical cooling system that could lead to a low power error (1301) being displayed on the screen. The console is designed to stop emitting laser pulses and enters a stand-by mode after a low power error message. | Terminated | null | 2019-04-08 | 2019-05-29 | null | 1 (OUS) | null | 1000116179 | 8 | 1 | No Action Indicated (NAI) | 2017-12-11 | 1 | 1 | 2014-04-10 | false | 0 | device_malfunction | cooling system failure |
D-0323-2017 | drug | Tri-Coast Pharmacy | Ultra Cocktail #2 (Methionine (L) 12.5mg/Inositol 25mg/Choline Chloride 25 mg/Methylcobalamin 300mcg/Carnitine (L) 170mg/Thiamine HCL 20mg/Riboflavin-5-Phosphate Sod 2mg/Pyridoxine HCL 2mg/Folic Acid 2mg/Ascorbic Acid 20mg/Chromium Picolinate 66mcg/Lidocaine HCL 10mg/mL), (30 ML and 10 ML). Compounded by Tri-Coast Pha... | Lack of Assurance of Sterility | Ongoing | null | 2016-11-17 | 2017-01-11 | Nationwide | 123 vials | null | 3011827553 | 1 | 1 | Official Action Indicated (OAI) | 2016-10-21 | 1 | 1 | 2018-08-20 | true | 0 | sterility | sterility assurance |
Z-2473-2023 | device | Siemens Healthcare Diagnostics, Inc. | Atellica CH Gamma-Glutamyl Transferase-IIn vitro diagnostic use in the quantitative determination of gamma-glutamyl transferase in human serum and plasma (lithium heparin Test Code: GGT Siemens Material Number (SMN): 11097597 | Potential for reagent carryover on the Atellica CH 930 resulting in a positive bias that could impact quality control (QC), patient samples, and calibrator results with from Atellica¿CH Total Bilirubin_2 (TBil_2), Atellica¿ CH LDL Cholesterol (LDLC), Atellica¿ CH Gamma-Glutamyl Transferase (GGT) and Atellica¿ CH HDL C... | Ongoing | null | 2023-07-10 | 2023-09-06 | null | 19544 units | null | 2432235 | 9 | 1 | No Action Indicated (NAI) | 2024-05-24 | 1 | 1 | 2012-05-29 | false | -1 | device_malfunction | reagent carryover defect |
Z-0723-2015 | device | Stryker Endoscopy | PKG, 3.5MM TROCAR, PYRAMIDAL TIP, SHORT, P/N 0250080692 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electr... | The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity cycle and the Ethylene Oxide cycle sterilization methods | Terminated | null | 2014-11-17 | 2014-12-24 | null | 180,573 units total | null | null | null | null | null | null | 0 | 0 | null | false | null | device_malfunction | sterilization incompatibility |
Z-1873-2021 | device | Medtronic Perfusion Systems | Medtronic BB10R94R6, Custom Pack BB10R94R6 1/4 ECCPK, Custom Perfusion System, Sterile, Rx. | Specific lots may have been manufactured with insufficient or incomplete welds. | Terminated | null | 2021-04-29 | 2021-06-23 | null | 10 tubing packs | null | 1718389 | 3 | 0 | No Action Indicated (NAI) | 2016-06-17 | 0 | 0 | null | false | 0 | cGMP | incomplete welds |
D-567-2014 | drug | Aidapak Services, LLC | ISOMETHEPTENE MUCATE/ DICHLORALPHENAZONE/APAP Capsule, 65 mg/100 mg/325 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 44183044001 | Labeling: Label Mixup; ISOMETHEPTENE MUCATE/ DICHLORALPHENAZONE/APAP Capsule, 65 mg/100 mg/325 mg may be potentially mislabeled as ALBUTEROL SULFATE ER, Tablet, 4 mg, NDC 00378412201, Pedigree: W003578, EXP: 6/24/2014; LOSARTAN POTASSIUM, Tablet, 25 mg, NDC 16714058102, Pedigree: AD22616_7, EXP: 5/2/2014. | Terminated | null | 2013-07-02 | 2014-01-22 | Repacked drugs were distributed in Arizona, California, Oregon, and Washington. | 200 Capsules | null | 3008673824 | 3 | 0 | Voluntary Action Indicated (VAI) | 2013-07-31 | 0 | 0 | null | false | -1 | mislabeling | label mixup |
Z-1561-2014 | device | Teleflex Medical | Deknatel Teleflex Medical Silk Black Braided Silk Suture Nonabsorbable Surgical Suture U.S.P. Indicated for use in soft tissue approximation. | Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use. | Terminated | null | 2014-03-11 | 2014-05-14 | null | 32,271 ea. | null | 3005428244 | 1 | 0 | No Action Indicated (NAI) | 2010-06-01 | 0 | 0 | null | false | 0 | device_malfunction | needle detachment |
Z-0950-2019 | device | Arrow International Inc | AF 550 x 8ML/HR 2ML 15LO CPNBMT8015XL CP, Product code MT8015XL CPNB, Arrow AutoFuser Disposable Pain Control Pump | Possible cracks on the body of the fill port connector, which may result in a leak. If the leak is identified while the user is filling the pump, there may be a delay while an alternative pump is located. If the leak goes undetected it may result in a reduced level of drug delivery to the patient and consequently a l... | Terminated | null | 2018-10-02 | 2019-03-06 | null | 1 | null | null | null | null | null | null | 0 | 0 | null | false | null | device_malfunction | cracked fill port connector |
Z-0141-2014 | device | Steris Corporation | Harmony Equipment Management System, Model #603X/80XX, STERIS Corporation, Mentor, OH Harmony Equipment Management Systems (EMS) are used in hospital facilities to provide ready access to medical gasses, electrical power and audio/visual data services, in addition to managing surgical support equipment such as endos... | Dr¿ger Medical GmbH has notified STERIS of the potential for a break in the drive screw contained in the motorized ceiling supply unit, a component of the Harmony EMS system. The ceiling supply unit controls the motorized adjustment of the height and rotation of the supply column. Should a break occur in the drive sc... | Terminated | null | 2013-08-15 | 2013-11-13 | null | 127 units | null | 1923569 | 4 | 0 | Voluntary Action Indicated (VAI) | 2022-03-31 | 0 | 0 | null | false | -1 | device_malfunction | drive screw failure |
D-0646-2020 | drug | AAA Pharmaceutical, Inc. | Ranitidine 150 mg tablets, 130 count bottles, NDC 37808-196-04. | CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API | Terminated | null | 2019-12-26 | 2020-01-15 | Product was distributed to one consignee who may have distributed the product further to their retail stores. | 31,536 (130-count bottles) | null | 2246707 | 6 | 0 | Voluntary Action Indicated (VAI) | 2024-05-15 | 0 | 0 | null | false | -1 | cGMP | NDMA impurity |
Z-2545-2018 | device | Life Technologies, Corp. | Gibco Dulbecco's Modified Eagle Medium (DMEM), high glucose, Model Number 11965175. Tissue and cell culture medium. | It has been determined that the fill port tube seal integrity was compromised during the manufacture of the product lot. This may cause media to leak out of the primary sterile packaging into outer non-sterile dust cover packaging, and subsequently mold may grow in the pooled, leaked media. | Terminated | null | 2018-05-10 | 2018-08-01 | null | 91 | null | null | null | null | null | null | 0 | 0 | null | false | null | sterility | compromised seal integrity |
Z-0620-2016 | device | Boston Scientific Corporation | Boston Scientific, MRI PROPONENT" SR , REF L210 Pacemaker. These devices treat bradycardia (slow heartbeats) with RA and/or RV pacing therapy as necessary | The literature packet packaged with the devices incorrectly describes the pacemaker as SR when it is actually a DR pacemaker or DR when it is actually a SR pacemaker. | Terminated | null | 2015-12-10 | 2016-01-20 | null | 5 | null | 1051710 | 1 | 0 | No Action Indicated (NAI) | 2012-02-29 | 0 | 0 | null | false | 0 | mislabeling | pacemaker type error |
D-0183-2026 | drug | CA BOTANA International, Inc. | Doctor. D. Schwab Mineral Sunscreen SPF 50, Zinc Oxide 21%, 4 oz./ 113.4 g per tube, Manufactured by CA Botana, San Diego, CA 92123. NDC: 35192-042-02 | CGMP Deviations | Ongoing | null | 2025-10-10 | 2025-12-03 | CA, CO, FL, PR, WA | 1167 tubes | null | 2023910 | 4 | 1 | Official Action Indicated (OAI) | 2025-04-04 | 0 | 0 | null | true | 0 | cGMP | CGMP deviations |
Z-0348-2025 | device | Baxter Healthcare Corporation | Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009 | The door on the Spectrum IQ Infusion pump may not be able to fully close. | Ongoing | null | 2024-10-02 | 2024-11-20 | null | 8 units | null | 1036337 | 4 | 0 | No Action Indicated (NAI) | 2017-08-23 | 0 | 0 | null | false | 0 | device_malfunction | door closure failure |
D-1183-2022 | drug | Wedgewood Village Pharmacy, LLC | Boric Acid 600 mg capsules, 14 capsules per box, Qty: 1, Wedgewood Village Pharmacy LLC, 405 Heron Drive, Ste 200, Swedesboro, NJ 08085 | Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection | Terminated | null | 2022-06-10 | 2022-07-13 | Products were distributed nationwide in the USA. | 1 box | null | 3001779702 | 3 | 1 | Voluntary Action Indicated (VAI) | 2022-03-24 | 1 | 1 | 2014-02-21 | false | 0 | cGMP | insanitary processing conditions |
Z-0721-2014 | device | Boston Scientific Corporation | TWISTER PLUS 22mm Rotatable Retrieval Device (Box of 10 configuration) Universal Product Number (UPN):M00561412. Distributed by: Boston Scientific, Natick, MA. Manufactured by: Horizons International Corp., Costa Rica Intended to be used in flexible endoscopes as a retrieval device for foreign body objects, such as ... | Sterility of device may be compromised due to lack of pouch seal integrity | Terminated | null | 2013-11-20 | 2014-01-22 | null | 740 eaches | null | 1000120754 | 3 | 0 | Voluntary Action Indicated (VAI) | 2014-10-09 | 0 | 0 | null | false | -1 | sterility | pouch seal integrity |
Z-2046-2016 | device | Implant Direct Sybron Manufacturing, LLC | 6534-08N InterActive¿ Implant Open-Tray Transfer Narrow Part Number: 6534-08N Product Usage: Intended Use of Implant Direct Open Tray Transfers are to capture implant position in an elastomeric impression of the mandible or maxilla. Open Tray transfers stay within the Impression material prior to delivery to the ... | The incorrect sized product, InterActive Implant Open-Tray Transfer Wide, 6534-08W, was packaged instead of the InterActive Implant Open-tray Transfer Narrow, 6534-08N, causing a possible issue with the impression. This discrepancy may lead to the possibility of an oversized crown fabrication. | Terminated | null | 2016-05-19 | 2016-06-29 | null | 48 | null | null | null | null | null | null | 0 | 0 | null | false | null | packaging | incorrect product packaged |
Z-1419-2022 | device | DePuy Orthopaedics, Inc. | ATTUNE Measured Sizing and Rotation Guide-to size the femur and align rotation of the bone cuts in preparation for the femoral implant Part Number: 254400525 | Manufactured with a Galvanized High Carbon Steel spring instead of the correct 302 Stainless steel spring. has the potential to oxidize and corrode in the ATTUNE Measured Sizing & Rotation Guide, resulting in surgical delay, debris in surgical field, Osteolysis, Poor Joint Mechanics, Soft Tissue Irritation, Pain | Ongoing | null | 2022-06-29 | 2022-07-27 | null | 872 units | null | 1219655 | 2 | 0 | No Action Indicated (NAI) | 2015-09-24 | 0 | 0 | null | false | 0 | device_malfunction | material substitution defect |
D-0905-2023 | drug | L. Perrigo Company | Allergy ALLER-FEX, Fexofenadine Hydrochloride Tablets, 180 mg, 180-count cartons, Packaged by: Perrigo, 515 Eastern Ave., Allegan, MI 49010 USA. NDC 63981-847-48 | Failed Impurities/Degradation Specifications | Terminated | null | 2023-02-09 | 2023-07-19 | Nationwide within the USA | 360,184 | 63981-847 | 1811666 | 20 | 1 | Voluntary Action Indicated (VAI) | 2025-03-19 | 1 | 1 | 2010-04-29 | false | -1 | stability | impurity degradation |
D-0377-2018 | drug | Sage Products Inc | Q CARE q4 Oral Cleansing & Suctioning System, Contains 1 Covered Yankauer and Y-Connector, 2 Suction Toothbrush packages with Antiplaque solution, 4 Suction Oral Swab packages with Perox-A-Mint solution, 2 Oropharyngeal Suction Catheter packages, Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code... | Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products | Terminated | null | 2017-08-22 | 2018-02-21 | Distributed Nationwide in the USA and Puerto Rico, Canada, United Kingdom, Ireland, Netherlands, New Zealand | 9,110 cases | null | null | null | null | null | null | 0 | 0 | null | false | null | contamination | cross contamination |
Z-2154-2025 | device | MEDLINE INDUSTRIES, LP - Northfield | Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: IV START KIT LAB DRAW-SH, REF CDS860014P | Affected convenience kits contain BD ChloraPrep Clear - 1 mL Applicators, which were recalled by BD due to potential to exhibit an open seal on its packaging. This may constitute a breach to sterility, which may in turn lead to the infection related harms for the patient. | Ongoing | null | 2025-06-12 | 2025-07-30 | null | 184 units | null | null | null | null | null | null | 0 | 0 | null | false | null | sterility | open seal packaging |
Z-1390-2021 | device | Siemens Healthcare Diagnostics, Inc. | ADVIA 2120i with Single Aspirate Autosampler (SMN 10488923) - US, automated hematology analyzer Software Versions 6.10 and 6.11 | Potential Sample Identification (SID) Mismatch with14-Character Barcodes | Ongoing | null | 2021-03-05 | 2021-04-21 | null | 15 units | null | 2432235 | 9 | 1 | No Action Indicated (NAI) | 2024-05-24 | 1 | 1 | 2012-05-29 | false | -1 | software | barcode identification error |
Z-3084-2024 | device | Baxter Healthcare Corporation | Baxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175, for use in a pharmaceutical compounding device | Baxter Healthcare Corporation has received increased customer reports of particulate matter in the Automated Compounding Device Inlets (disposable inlet), Product Codes H938173, H938174, H938175, H938176, used with the ExactaMix and ExactaMix Pro compounders. Particulate matter has been observed within the inlet primar... | Ongoing | null | 2024-08-20 | 2024-09-25 | null | 5,828,540 units | null | 1036337 | 4 | 0 | No Action Indicated (NAI) | 2017-08-23 | 0 | 0 | null | false | 0 | foreign_material | particulate matter inlet |
Z-0688-2026 | device | B Braun Medical Inc | IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/ B/C VALVE,103 IN.; Catalog Number: 470179. | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). | Ongoing | null | 2025-10-29 | 2025-12-03 | null | 28,344 units | null | null | null | null | null | null | 0 | 0 | null | false | null | device_malfunction | backflow and occlusion |
Z-0752-2015 | device | Stryker Endoscopy | PKG, 5MM X 45CM INSERT, DISSECTING FORCEPS, P/N 0250080762 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for ele... | The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity cycle and the Ethylene Oxide cycle sterilization methods | Terminated | null | 2014-11-17 | 2014-12-24 | null | 180,573 units total | null | null | null | null | null | null | 0 | 0 | null | false | null | device_malfunction | sterilization incompatibility |
Z-0968-2023 | device | Cardinal Health 200, LLC | Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2187 | Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of radiopacity in wound drains, dull trocars impacting product performance, lack of flexibility of wound drains, and broken wound tips. | Ongoing | null | 2022-12-14 | 2023-01-25 | null | 4111 devices | null | 3030940002 | 1 | 0 | No Action Indicated (NAI) | 2025-10-30 | 0 | 0 | null | false | -1 | device_malfunction | drain performance defects |
Z-1421-2017 | device | Siemens Healthcare Diagnostics, Inc | IMMULITE 2000 Progesterone; Catalog Number: L2KPW2 L2KPW6; Siemens Material Number: 10381181, 10381170 Product Usage: For in vitro diagnostic use with the IMMULITE¿ and IMMULITE 1000 Analyzers - for the quantitative measurement of progesterone in serum as an aid in the diagnosis and treatment of disorders of the ... | DHEA-S causes falsely elevated progesterone results. | Terminated | null | 2017-01-04 | 2017-03-15 | null | 11963 | null | null | null | null | null | null | 0 | 0 | null | false | null | software | test result interference |
D-0083-2019 | drug | Lannett Company, Inc. | HydrOXYzine HYDROCHLORIDE SYRUP (HydrOXYzine Hydrochloride Oral Solution, USP), 10 mg per 5 mL, Rx only, Distributed by Lannett Company, Inc., Philadelphia, PA 19154, NDC 54838-502-80. | CGMP Deviations: cleaning procedures during manufacturing caused out of specification results for unknown impurities. | Terminated | null | 2018-10-11 | 2018-10-31 | Nationwide in the USA | 8,324 bottles | 54838-502 | 3006174033 | 1 | 0 | No Action Indicated (NAI) | 2010-09-14 | 0 | 0 | null | false | 0 | cGMP | cleaning procedure deviation |
D-0785-2016 | drug | Safecor Health, LLC | Phenobarbital/Hyoscyamine/ Atropine/Scopolamine 16.2/0.1037/0.0194/0.0065 mg DONNATAL ELIXIR, 5 ml Cup grape, Alcohol 23.8%, Rx Only, MFG: Concordia, PKG BY: SAFECOR HEALTH, WOBURN, MA, C5921242304. | Labeling: Label Error on Declared Strength: Label incorrectly identifies product dose as 5ml instead of 10 ml. | Terminated | null | 2015-07-16 | 2016-04-06 | NY | 23 cups | null | 1218914 | 6 | 2 | Voluntary Action Indicated (VAI) | 2025-10-28 | 1 | 1 | 2023-09-05 | false | -1 | mislabeling | incorrect dose volume |
Z-1767-2025 | device | Baxter Healthcare Corporation | Baxter Novum IQ LVP INFUSION SYSTEM, REF 40700BAXUS | There is a potential for the Novum IQ LVP due to the potential for underinfusion following use of the "standby mode" feature or if the device is powered off with the set loaded. | Ongoing | null | 2025-04-24 | 2025-05-28 | null | 34,524 units | null | 1416980 | 17 | 2 | Official Action Indicated (OAI) | 2024-08-01 | 1 | 1 | 2014-01-17 | true | 0 | device_malfunction | underinfusion risk |
Z-0006-2018 | device | Permobil, Ab | Electric Wheelchair bases: a) C300 b) C350 c) C400 d) C500 | There is a potential failure of the top plate assembly, which is the component that connects the seating system of the wheelchair to the base. | Terminated | null | 2017-09-01 | 2017-10-11 | null | 146 units | null | null | null | null | null | null | 0 | 0 | null | false | null | device_malfunction | top plate assembly failure |
Z-1701-2022 | device | American Contract Systems, Inc. | Various ob/gyn packs | Product was exposed to multiple sterilization cycles without validation for multiple exposures. | Ongoing | null | 2022-06-16 | 2022-09-14 | null | 15 units | null | 3003309947 | 5 | 1 | No Action Indicated (NAI) | 2025-04-17 | 0 | 0 | null | false | -1 | cGMP | sterilization validation |
Z-0180-2024 | device | American Contract Systems, Inc. | Sub Q Recorder Pack, REF BPRC87A | During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and Adhesive Dermabond (part number DHVM12) were inadvertently subjected to the ACS sterilization process and exposed to EO and higher temperatures than approved by the component manufacturer. As a result, the com... | Ongoing | null | 2023-09-01 | 2023-11-01 | null | 96 cases | null | 3003368406 | 3 | 0 | Voluntary Action Indicated (VAI) | 2017-05-11 | 0 | 0 | null | false | 0 | cGMP | unauthorized sterilization process |
Z-0087-2024 | device | Cardinal Health 200, LLC | Procedure packs: (1) Presource PBDS, Cat. PGMHSUESR, Southeast Hospital MHHS, Kit, Set Up No Drape, SE, Sterile; (2) Presource PBDS Cat. PGVGLBP20, Parkview Medical Center, Kit, Lap Chole, Sterile; (3) Presource PBDS Cat. PG63CCC31, USPI Christ Hosp Spine Srgry C, Kit, Basic, Sterile; (4) Presource PBDS Cat. PG63... | Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits). | Ongoing | null | 2023-08-16 | 2023-10-18 | null | 13,351 total packs | null | 3001236905 | 4 | 1 | Official Action Indicated (OAI) | 2023-12-20 | 1 | 1 | 2024-04-24 | false | -1 | foreign_material | recalled components |
Z-1086-2024 | device | Quidel Corporation | The Sofia 2 Flu + SARS Antigen FIA employs immunofluorescence technology in a sandwich design that is used with Sofia 2 to detect nucleocapsid protein from influenza A, influenza B, and SARS-CoV-2. This test allows for the detection of SARS-CoV and SARS-CoV-2, but does not differentiate between the two viruses. | One lot of the Sofia 2 Flu + SARS Antigen FIA (Lot 709083) was labelled with incorrect expiration dates. The kits contain pouched cassettes labeled with an expiration date of May 31, 2025, however the correct expiration date for the pouches is September 12, 2024. The kits are labeled with an expiration date of April 30... | Ongoing | null | 2024-01-03 | 2024-02-21 | null | 312 Kits | null | 1000122536 | 6 | 0 | No Action Indicated (NAI) | 2021-08-03 | 0 | 0 | null | false | 0 | mislabeling | incorrect expiration dates |
Z-0243-2024 | device | Stryker Corporation | Disposable Spetzler-Malis Bipolar forceps, 23CM SM DISP BAYONET 1.0MM TIP, Catalog Number 6760-230-010 | An error was identified on the expiration date of the product label. The shelf life for the products impacted is 36 months (3 years) however the product label represents a 54 month (4.5 year) shelf life. | Ongoing | null | 2023-09-11 | 2023-11-15 | null | 2,321 total units | null | 1811755 | 6 | 2 | No Action Indicated (NAI) | 2016-01-07 | 1 | 1 | 2013-03-06 | false | 0 | mislabeling | incorrect expiration date |
D-0445-2021 | drug | Cardinal Health Inc. | MURO-128 2% 15ML OPTH; NDC/UPC 324208276150; OTC; DROPS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Terminated | null | 2021-03-15 | 2021-06-02 | FL, GA, SC | 64 droptainers | null | 3004008697 | 5 | 0 | No Action Indicated (NAI) | 2017-09-12 | 0 | 0 | null | false | 0 | cGMP | temperature excursion |
Z-1080-2025 | device | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | AlluraXper FD20 System Code: (1) 722006 (2) 722012 (3) 722028 | Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the longitudinal guiding rails and the tabletop. This may result in an injury of the finge... | Ongoing | null | 2025-01-13 | 2025-02-12 | null | 1528 units US; 3482 units OUS | null | 3000976525 | 1 | 1 | Official Action Indicated (OAI) | 2025-01-17 | 0 | 0 | null | false | -1 | device_malfunction | finger entrapment hazard |
D-1516-201 | drug | Lupin Limited | Escitalopram Tablets USP 20 mg, 100-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Baltimore, MD, 21202, Manufactured by: Lupin Limited, Goa 403 722, India, NDC 68180-136-01 | Labeling: Incorrect or Missing Lot and/or Expiration Date | Terminated | null | 2016-03-24 | 2016-09-28 | Nationwide | 3,192 bottles (319,200 tablets) | 68180-137 | 3007549629 | 5 | 3 | Official Action Indicated (OAI) | 2019-01-25 | 1 | 1 | 2017-11-06 | false | -1 | mislabeling | missing lot/expiration |
D-1340-2020 | drug | Akorn, Inc. | Prednisolone Sodium Phosphate Oral Solution, 5 mg/5 mL, 120 mL Bottle, Rx only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701. NDC: 50383-040-04 | Discoloration: Out of Specification (OOS) result for APHA Color Test. | Terminated | null | 2020-06-05 | 2020-06-17 | Distributed Nationwide in the USA | 17,424 bottles | null | 3003102962 | 5 | 0 | No Action Indicated (NAI) | 2019-03-05 | 1 | 1 | 2012-10-02 | false | 0 | stability | discoloration OOS |
Z-1532-2025 | device | Omnicell, Inc. | IVX Station Reconstitution Transfer Set. Model Number: 298921215. Packaging: 1 set per White Tyvek Pouch, 5 Tyvek Pouches per shelf box, 10 shelf boxes per case box. IVX Station Reconstitution Transfer Set is used for the reconstitution of drug vials in hospital pharmacies. It is indicated for use with the IVX Stat... | IVX Station Reconstitution Transfer Sets were shipped in advance of the IVX Station upgrade and not intended for clinical use but are engineering devices intended for use during set up and system calibration. The items were not shipped in a validated packing configuration and sterility cannot be ensured. | Ongoing | null | 2025-02-20 | 2025-04-16 | null | 3 | null | 3011278888 | 2 | 0 | Voluntary Action Indicated (VAI) | 2024-02-01 | 0 | 0 | null | false | 0 | sterility | unvalidated packaging |
Z-0063-2021 | device | Medline Industries Inc | Kit Model #650301023, MTO Radiology Kit Cleveland Clinic - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist of any combination of devices from the NAMIC Fluid Management finished good product families and potentially other devices designed and manufactured by original equipment manufacturers... | Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities. | Terminated | null | 2020-09-14 | 2020-10-14 | null | 20 kits | null | 3006662398 | 1 | 0 | No Action Indicated (NAI) | 2019-03-06 | 0 | 0 | null | false | 0 | sterility | non-sterile distribution |
Z-1683-2024 | device | Boston Scientific Corporation | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL1 (5PK), REF H74908526962; cardiac catheter | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining. | Ongoing | null | 2024-03-21 | 2024-05-22 | null | 37252 catheters | null | 2648729 | 5 | 0 | No Action Indicated (NAI) | 2021-07-21 | 0 | 0 | null | false | 0 | device_malfunction | polyurethane delamination |
Z-2613-2017 | device | Abbott Laboratories | ARCHITECT SHBG Reagent The ARCHITECT SHBG assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of sex hormone binding globulin (SHBG) in human serum and plasma on the ARCHITECT iSystem. The ARCHITECT SHBG assay is used as an aid in the diagnosis of androgen disorders. | Firm has identified that ARCHITECT SHBG results generated with the Potassium EDTA specimen tube type may demonstrate a negative shift relative to results generated with serum. There is a potential for falsely decreased ARCHITECT SHBG results to be generated when using the ARCHITECT SHBG assay with the Potassium EDTA s... | Terminated | null | 2017-04-18 | 2017-06-28 | null | 7981 kits | null | 3016438761 | 1 | 0 | No Action Indicated (NAI) | 2021-11-10 | 0 | 0 | null | false | -1 | device_malfunction | assay accuracy shift |
Z-1256-2021 | device | Cardinal Health 200, LLC | JUDKINS PACK | Component Part Number: 19537LBL (LBL, SHEET OF 39, ASSORTED, STDSZ, MULTI W/BLK INK, WATERPROOF) is being reported as intermittently mixed with an incorrect medication label sheet throughout the specific Presource¿ kit SANHDJTVCF Judkins Pack lot # 525067. | Terminated | null | 2021-02-11 | 2021-03-24 | null | 298 units | null | 3004259653 | 2 | 0 | No Action Indicated (NAI) | 2018-01-18 | 0 | 0 | null | false | 0 | mislabeling | incorrect label sheets |
Z-1123-2021 | device | Baxter Healthcare Corporation | Gambro Cartridge Low Weight-Low Volume Blood Transport System for Hemodialysis Blood Set, product code 114435 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems. | complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received. | Ongoing | null | 2020-12-30 | 2021-02-24 | null | 25785 devices | null | 2650090 | 9 | 1 | Voluntary Action Indicated (VAI) | 2025-03-26 | 1 | 1 | 2011-01-20 | false | -1 | device_malfunction | kinked access lines |
Z-2152-2025 | device | Beckman Coulter Inc. | Estrone RIA, REF: DSL8700. Estrone RIA is an IVD used for the quantitative measurement of estrone in human serum and plasma. | A specific lot of bovine serum albumin (BSA) used for manufacturing of coated tubes (CT) that are included in the Estrone RIA kit lots caused different affinity of manufactured coated tubes to patient samples, causing falsely increased assay results for the impacted Estrone RIA kits. | Ongoing | null | 2025-06-12 | 2025-07-30 | null | 496 units | null | 2050012 | 7 | 1 | No Action Indicated (NAI) | 2021-08-05 | 2 | 2 | 2011-08-01 | false | 0 | potency | altered assay performance |
D-0948-2023 | drug | Central Admixture Pharmacy Services, Inc. | vancomycin 1 g/250 mL added to 0.9% sodium chloride, 4 mg/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6064-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Terminated | null | 2023-07-14 | 2023-08-09 | Nationwide in the USA | 3,980 bags | null | 3009590582 | 4 | 3 | Official Action Indicated (OAI) | 2023-03-30 | 3 | 3 | 2024-03-29 | true | 0 | sterility | insufficient validation data |
Z-1137-2013 | device | GE Healthcare, LLC | GE Healthcare, AW Server. Product Usage: . AW Server is a medical software system that allows multiple users to remotely access AW applications from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images. Both the client and server software a... | GE Healthcare has recently become aware of a potential safety issue with respect to the Results Viewer in the AW Server. After starting the Results Viewer with the selected series of a patient, the pixel and certain annotation data from a different patient is displayed in one of the viewports. This occurs on an occa... | Terminated | null | 2012-06-28 | 2013-04-24 | null | 429 | null | null | null | null | null | null | 0 | 0 | null | false | null | software | data display error |
D-0539-2021 | drug | Cardinal Health Inc. | ZOLPIDEM TARTRATE SUBLINGUAL TABLET 3.5 MG 30 UNIT DOSE POUCHES; NDC/UPC 49884089911; RX; EACH POUCH CONTAINS ONE SUBLINGUAL TABLET | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Terminated | null | 2021-03-15 | 2021-06-02 | FL, GA, SC | 55 Boxes | null | 1000148701 | 3 | 0 | No Action Indicated (NAI) | 2020-02-19 | 0 | 0 | null | false | 0 | cGMP | temperature excursion |
D-910-2013 | drug | Novartis Consumer Health | Maalox Nighttime Antacid with Acid Reflux Barrier (calcium carbonate and alginic acid) chewable tablets, 500 mg/200 mg, Cherry flavor, 65-count tablets per bottle, Novartis Consumer Health Canada Inc., Mississauga, ON L5N 2X7, foreign labeling containing English and French, NPN 80000899, UPC 0 58478 10090 6. | Labeling: Incorrect or Missing Lot and/or Exp Date: The lot number and/or expiration date may be illegible on the outer plastic bottle packaging. | Terminated | null | 2013-08-06 | 2013-08-28 | Nationwide, Canada, and Panama. | 11,760 bottles | null | null | null | null | null | null | 0 | 0 | null | false | null | mislabeling | illegible lot/exp date |
Z-0657-2021 | device | Boston Scientific Corporation | IceFORCE" 2.1 CX 90¿ Cryoablation Needle | Complaint trend regarding needle shaft gas leaks. | Completed | null | 2020-11-18 | 2020-12-30 | null | 22,289 units | null | 3001236349 | 8 | 0 | No Action Indicated (NAI) | 2019-09-25 | 0 | 0 | null | false | 0 | device_malfunction | needle shaft gas leaks |
D-0312-2025 | drug | SUN PHARMACEUTICAL INDUSTRIES INC | Gabapentin Capsules, USP 400 mg, Rx Only, Packaged in a) 500-count bottles, NDC 62756-139-05; b) 1000-count bottles, NDC 62756-139-04; Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway, Halol-389 350, Gujarat, India. | Cross Contamination | Ongoing | null | 2025-03-04 | 2025-04-16 | Nationwide in the USA | 852 bottles | 62756-137 | 3013472760 | 13 | 1 | No Action Indicated (NAI) | 2024-12-12 | 1 | 1 | 2010-08-25 | false | 0 | contamination | cross contamination |
D-1773-2015 | drug | The Compounding Pharmacy of America | Tri-Mix (25/2.5/10) (MFG) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility | Terminated | null | 2015-06-02 | 2015-09-23 | Nationwide | 12 ml | null | null | null | null | null | null | 0 | 0 | null | false | null | sterility | GMP violations |
D-0413-2016 | drug | Western Drug | Medroxyprogesterone 150/LID 5 mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Lack of Assurance of Sterility | Terminated | null | 2015-10-19 | 2015-12-09 | Nationwide in US: Arizona, California, Georgia, New Mexico, South Carolina, South Dakota, Texas, and Utah | 17 containers | null | null | null | null | null | null | 0 | 0 | null | false | null | sterility | sterility assurance |
D-1051-2014 | drug | NuVision Pharmacy, Inc. | HCG (Lyophilized) Stock # 21714, 5000 IUnits-5 mL vial, Compounded by NuVision Pharmacy Dallas, TX 75244 | Lack of Assurance of Sterility: The recall is being initiated due to a lack of sterility assurance and concerns associated with the quality control processes identified during an FDA inspection. | Terminated | null | 2013-04-15 | 2014-02-05 | Nationwide | 285 vials | null | null | null | null | null | null | 0 | 0 | null | false | null | sterility | QC process deficiency |
Z-1028-2020 | device | Cardinal Health | AAMI 3 NON-REINF SURGICAL GOWN XXL, Item Code 9575 | The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. | Terminated | null | 2020-01-11 | 2020-02-12 | null | 7,659,634 total units | null | 3011200334 | 1 | 0 | No Action Indicated (NAI) | 2017-01-25 | 0 | 0 | null | false | 0 | contamination | bioburden and particulates |
Z-1426-2025 | device | American Contract Systems, Inc. | Brand Name: Banner University Med Ctr. Product Name: Cardiac Cath Lab Pack-170278 Model/Catalog Number: GSCC40G Software Version: N/A Product Description: Convenience Kit Component: No | Sterility assurance with procedure trays | Ongoing | null | 2025-01-31 | 2025-04-02 | null | 460 kits. | null | 3003368406 | 3 | 0 | Voluntary Action Indicated (VAI) | 2017-05-11 | 0 | 0 | null | false | 0 | sterility | procedure tray sterility |
D-0027-2023 | drug | Pharmacy Plus, Inc. dba Vital Care Compounder | ACETYLCYSTEINE OPTH 5% Solution, 15 mL droptainers, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402 | Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile. | Ongoing | null | 2022-10-07 | 2022-11-09 | AL, LA, MS, and TN | 2 droptainers | null | null | null | null | null | null | 0 | 0 | null | false | null | sterility | manufacturing process failure |
D-1425-2015 | drug | Mutual Pharmaceutical Company, Inc. | Imipramine HCl Tablets, USP, 50 mg, 100 count bottles, Mfd By: Mutual Pharmaceutical Co., Inc., Philadelphia, PA --- NDC 54738-914-01 | Chemical Contamination; benzophenone leached from the product label varnish | Terminated | null | 2015-07-16 | 2015-09-16 | Nationwide | 10,080 bottles | null | null | null | null | null | null | 0 | 0 | null | false | null | contamination | benzophenone leaching |
Z-0582-2016 | device | Vidco, Inc. | Remote Patient Monitoring System, MDP 2000 Series, Part Numbers: MDP2040-0100, PGM340R3, or PGM340R4. The MDP2000 is intended for use in conjunction with patient monitoring equipment. The MDP2000 is not patient connected Examples of areas where the MDP200 is used include ICU, CCU, PACU, Emergency, Telemetry Step-dow... | Testing at customer site showed unit Remote Patient Monitoring System MDP2040-0100 in a continuous trap condition, not allowing system to reset and reboot. Two customers recently complained of the system freezing and it could only be restarted if the user re-applied power. | Terminated | null | 2015-11-08 | 2016-01-13 | null | 59 units | null | 3020646 | 5 | 1 | No Action Indicated (NAI) | 2018-02-08 | 1 | 1 | 2017-05-05 | false | -1 | device_malfunction | system freeze condition |
Z-3115-2024 | device | MEDLINE INDUSTRIES, LP - Northfield | Medline convenience kits containing semi-rigid suction liners labeled as follows: NICU ADMIT KIT, Pack Number DYKA1014G | Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/2023 due to the potential loss of suction or low suction during intermittent suction use. | Ongoing | null | 2024-06-27 | 2024-09-18 | null | 444 units | null | null | null | null | null | null | 0 | 0 | null | false | null | device_malfunction | suction loss |
Z-0929-2022 | device | Siemens Healthcare Diagnostics, Inc. | Atellica CH Enzymatic Hemoglobin A1c (A1c_E/A1c_H), Siemens Material Number 11097536 | Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting quality control (QC), patient samples, and calibrator results. | Ongoing | null | 2022-02-09 | 2022-04-20 | null | 6606 | null | 1000660462 | 1 | 0 | No Action Indicated (NAI) | 2013-04-03 | 0 | 0 | null | false | 0 | cGMP | reagent carryover |
Z-0380-2015 | device | Customed, Inc | Laparoscopy Chole Pack, Catalog number 900-414. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. | Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection. | Terminated | null | 2014-10-08 | 2014-12-10 | null | 440 | null | null | null | null | null | null | 0 | 0 | null | false | null | sterility | manufacturing deficiencies |
Z-1314-2019 | device | Becton Dickinson & Co. | BD Veritor System Reader -In Vitro Diagnostic for use with BD Veritor System Test Kit Devices Catalog Number: 256055 | Background calibration has the potential to cause false positive or false negative test results. An incorrect test result with the BD Veritor System could lead to possible misdiagnosis and inappropriate treatment | Terminated | null | 2019-04-03 | 2019-05-22 | null | 124 | null | 1000220943 | 1 | 0 | No Action Indicated (NAI) | 2011-08-12 | 0 | 0 | null | false | 0 | software | calibration algorithm error |
Z-0189-2019 | device | Siemens Healthcare Diagnostics, Inc. | Atellica Sample Handler Prime (SMN 11069001). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens. | Atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were identified: 1. Reagent Lock may not work as intended with Primary Reagent ReadyPacks¿ and Ancillary Packs when more than one (1) lot of specific Reagent kits are loaded on the analyzer at the same time. 2. Sample barcodes m... | Terminated | null | 2018-06-29 | 2018-10-24 | null | 107 | null | 2432235 | 9 | 1 | No Action Indicated (NAI) | 2024-05-24 | 1 | 1 | 2012-05-29 | false | -1 | software | behavioral issues |
Z-1866-2019 | device | Thermo Fisher Scientific (Asheville) LLC | Fisher Scientific Isotemp -General Purpose Water Bath: lsotemp 10L GP Bath Model Number: FSGPD10 | Product may have been assembled incorrectly,the assembly error can cause the bath to malfunction and raise the temperature of the fluid in the reservoir above the temperature set point selected by the user. | Terminated | null | 2019-04-02 | 2019-07-03 | null | 5 units | null | 1036832 | 4 | 0 | No Action Indicated (NAI) | 2023-08-24 | 0 | 0 | null | false | -1 | device_malfunction | assembly error temperature |
Z-0999-2013 | device | Trophy Sas | CareStream Dental CS 2100 X-ray system Product Usage: The expected usage (intended use) for all of these products is for dental radiographic examination and diagnosis of the teeth, jaw and oral structures. | There have been approximately 2% of the x-ray generators manufactured between February 2012 and November 2012 returned due to errors. These generators showed the type of defect that indicates poor contact of HT transformer power pin. The defect is a bent connector associated with the generator. | Terminated | null | 2012-09-18 | 2013-05-08 | null | 167 installed in the US | null | 7695 | 2 | 0 | Voluntary Action Indicated (VAI) | 2023-03-10 | 0 | 0 | null | false | -1 | device_malfunction | bent connector defect |
Z-2721-2016 | device | Elekta, Inc. | Medical Linear Accelerator | There have been instances in hospitals where the joint between the drive gear and the gantry base drive wheel has become loose, leading to fatigue failure of some of the securing bolts. | Terminated | null | 2016-07-08 | 2016-09-14 | null | 553 | null | 1000123805 | 3 | 0 | No Action Indicated (NAI) | 2015-08-26 | 0 | 0 | null | false | 0 | device_malfunction | loose joint fasteners |
Z-2262-2019 | device | Degania Silicone, Ltd. | Cardinal Health Jackson-Pratt Channel Drain 15FR, Full flutes, with trocar Product Number: JP-2189 An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavit... | 15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in connection point between clear tube and white profile part. requiring additional surgical intervention to remove the broken end from patient's body | Terminated | null | 2019-06-28 | 2019-08-21 | null | 6080 | null | null | null | null | null | null | 0 | 0 | null | false | null | device_malfunction | breakage during removal |
Z-0369-2022 | device | Cardinal Health | SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-Large SKU: 9011 | Potential for open packaging seals compromising the sterility of the surgical gowns | Ongoing | null | 2021-11-02 | 2021-12-22 | null | 169,262 units | null | 1921846 | 3 | 0 | No Action Indicated (NAI) | 2015-11-18 | 0 | 0 | null | false | 0 | packaging | compromised seal |
Z-0327-2022 | device | Boston Scientific Corporation | HURRICANE RX DILATION BALLOON 10MM 4CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545960 | Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure | Ongoing | null | 2021-10-21 | 2021-12-08 | null | null | 3001451463 | 6 | 0 | No Action Indicated (NAI) | 2016-04-08 | 0 | 0 | null | false | 0 | device_malfunction | pressure retention failure |
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.