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-0318-2015 | device | Customed, Inc | Hip Orthopedia Pack, Catalog number 900-1835. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. | Customed products are being recalled because of 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 | 36 | null | null | null | null | null | null | 0 | 0 | null | false | null | sterility | manufacturing deficiencies |
Z-0448-2014 | device | Smith & Nephew Inc | GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 5-6, 11 MM QTY: (1), REF 71421516, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic | The Tyvek(TM) lid on one, or both, of the two trays that form a double barrier around the insert may not have been adequately sealed. | Terminated | null | 2013-08-27 | 2013-12-11 | null | 46 pieces | null | 3005551626 | 3 | 0 | No Action Indicated (NAI) | 2015-07-23 | 0 | 0 | null | false | -1 | packaging | inadequate seal |
D-0451-2020 | drug | Altaire Pharmaceuticals, Inc. | OCuSOFT Tears Again Sterile Lubricant Eye Drops, Net Wt 30mL (1 fl oz), Manufactured for OCuSOFT Inc., Rosenberg, TX 77471 USA, NDC 54799-904-30 | Lack of Assurance of Sterility | Completed | null | 2019-07-02 | 2019-11-27 | U.S.A. Nationwide | 29326 units | null | 1000119582 | 13 | 2 | No Action Indicated (NAI) | 2024-10-21 | 2 | 2 | 2020-03-12 | false | -1 | sterility | assurance lacking |
D-0486-2021 | drug | Cardinal Health Inc. | Triumeq (abacavir, dolutegravir, and lamivudine) 600 mg/50 mg/300 mg Tablets 30 Tablets Rx Only NDC 49702-231-13 Manufactured for: Viiv Healthcare Research Triangle Park, NC 27709 by GlaxoSmithKline Research Triangle Park, NC 27709 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Terminated | null | 2021-03-15 | 2021-06-02 | FL, GA, SC | 2264 bottles | 49702-231 | 3003474118 | 3 | 0 | No Action Indicated (NAI) | 2025-02-19 | 0 | 0 | null | false | -1 | cGMP | temperature excursion |
Z-2168-2021 | device | ROi CPS LLC | Regard NEWBORN KIT, LD00201K, Item Number: 830016011. Medical convenience kit which includes an infant heel warmer. | Instructions for use updated to include the following cautionary statement for the heel warmer, "Activate away from the user's face and away from the infant and others." | Terminated | null | 2021-06-14 | 2021-08-11 | null | 688 units | null | 3014527682 | 2 | 0 | Voluntary Action Indicated (VAI) | 2022-10-28 | 0 | 0 | null | false | -1 | other | labeling update |
Z-2480-2020 | device | Ortho Clinical Diagnostics | VITROS 3600 Immunodiagnostic System Software Versions 3.3.3 and below Product Code: 6802783, Unique Identifier: 10758750002979 | Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset to default in certain circumstances | Terminated | null | 2020-05-20 | 2020-07-08 | null | 779 (U.S.= 225;OUS= 554) | null | null | null | null | null | null | 0 | 0 | null | false | null | software | parameter reset bug |
Z-0179-2024 | device | American Contract Systems, Inc. | Robotics Pack, REF SSRO22D | 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 | 56 cases | null | 3010126341 | 2 | 0 | No Action Indicated (NAI) | 2021-12-03 | 0 | 0 | null | false | 0 | cGMP | improper sterilization process |
Z-0561-2015 | device | Pfm Medical Inc | ASEPT Pleural Drainage System, Pleural Drainage Catheter Kit, Ref No. P09080001, M7001 Product Usage: The pfm medical ASEPT Pleural Drainage System is a tunneled, long term catheter used to drain accumulated fluid from the pleural cavity in order to relieve symptoms associated with pleural effusions. | PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin. | Terminated | null | 2014-10-20 | 2014-12-17 | null | 120 units | null | null | null | null | null | null | 0 | 0 | null | false | null | sterility | bacterial endotoxin |
Z-1544-2016 | device | Smith & Nephew, Inc. | TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 4 LEFT, STERILE R, REF 12 000 017, S&N 7500272, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis | The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during surgery. | Terminated | null | 2016-03-11 | 2016-04-27 | null | 24 units | null | 3006760724 | 4 | 1 | Voluntary Action Indicated (VAI) | 2015-01-13 | 1 | 1 | 2014-06-11 | false | 0 | device_malfunction | dimensional deviation |
Z-2758-2017 | device | Cardinal Health 200, LLC | Converters(R) Tiburon(R) Arthroscopy Drape, REF 9414, STERILE EO, Qty. 1, Cardinal Health, Waukegan, IL A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and oth... | Outer label of some units of product number/lot number 8482, Lot 16LFS235 and product number/lot number 9414, Lot 16LUS317 do not match the drape packaged inside. | Terminated | null | 2017-06-27 | 2017-08-02 | null | 528 each | null | 3034315018 | 1 | 0 | No Action Indicated (NAI) | 2025-09-18 | 0 | 0 | null | false | -1 | mislabeling | label content mismatch |
Z-2403-2019 | device | Siemens Medical Solutions USA, Inc | SOMATOM go.All; Models #11061638 Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data | The injector holder could potentially fall off together with the injector and the storage box. | Terminated | null | 2019-07-31 | 2019-09-04 | null | 0 | null | 2240869 | 3 | 0 | Voluntary Action Indicated (VAI) | 2022-10-26 | 0 | 0 | null | false | -1 | device_malfunction | holder detachment |
Z-0517-2025 | device | GE Medical Systems, LLC | Discovery MR750w 3.0T, whole body magnetic resonance scanner | Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning. | Ongoing | null | 2024-10-28 | 2024-12-04 | null | 8 units | null | 2183553 | 3 | 0 | No Action Indicated (NAI) | 2012-10-11 | 0 | 0 | null | false | 0 | device_malfunction | elevated acoustic noise |
D-0037-2022 | drug | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy | ESTRADIOL VALERATE 5MG/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 | assurance deficiency |
D-568-2014 | drug | Aidapak Services, LLC | FEXOFENADINE HCl Tablet, 60 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 45802042578 | Labeling: Label Mixup; FEXOFENADINE HCL Tablet, 60 mg may be potentially mislabeled as PYRIDOXINE HCL, Tablet, 50 mg, NDC 51645090901, Pedigree: W003019, EXP: 6/12/2014; NIACIN TR, Capsule, 500 mg, NDC 00904063160, Pedigree: AD60240_17, EXP: 5/22/2014; CRANBERRY EXTRACT/VITAMIN C, Capsule, 450 mg/125 mg, NDC 31604... | Terminated | null | 2013-07-02 | 2014-01-22 | Repacked drugs were distributed in Arizona, California, Oregon, and Washington. | 300 Tablets | null | 3008673824 | 3 | 0 | Voluntary Action Indicated (VAI) | 2013-07-31 | 0 | 0 | null | false | -1 | mislabeling | label mixup |
Z-2163-2018 | device | Smith & Nephew, Inc. | smith&nephew GENESIS(R) II TIBIAL Punch, 13 MM, REF 71440408, QTY: (1) | One lot of GENESIS II 13 mm tibial punches are 2 mm smaller than specification. | Terminated | null | 2018-05-04 | 2018-06-20 | null | 5 units | null | 1219602 | 3 | 0 | No Action Indicated (NAI) | 2017-05-25 | 0 | 0 | null | false | 0 | device_malfunction | undersized instrument |
Z-1384-2017 | device | Beckman Coulter Inc. | iChemVELOCITY Urine Chemistry System, Catalog No. 800-3530, 800-7167, 800-7719, 800-7720, 800-3564, 800-7100, 800-7103, 800-7106, 800-7162, 800-7163, 800-7166, 800-3061. The iChem Velocity automated urine chemistry system is used to test for the following analytes in urine: ketones, blood, protein, glucose, bilirubin,... | The probe misalignment or bending has the potential to lead to delay in reporting results or incorrect patient results. | Terminated | null | 2017-01-30 | 2017-03-08 | null | 3175 units total (1697 units in US) | null | 2050012 | 7 | 1 | No Action Indicated (NAI) | 2021-08-05 | 2 | 2 | 2011-08-01 | false | -1 | device_malfunction | probe misalignment |
Z-1069-2013 | device | AGFA Corp. | IMPAX CV 7.8 SU3 - OCR Service. The IMPAX CV Reporting component facilitates the quick , effective creation of digital structured reports for adult catheterization and echocardiography, pediatric echocardiography, congenital heart disease, nuclear cardiology and non-invasive vascular disease management. | Software design error in IMPAX CV 7.8 SU3 | Terminated | null | 2013-03-15 | 2013-04-17 | null | 2 | null | null | null | null | null | null | 0 | 0 | null | false | null | software | design error |
Z-1529-2015 | device | Beckman Coulter, Inc. | MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: Neg/BP Combo 47, Catalog B1017-417 Microbiology: For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram Negative Breakpoint Combo Panels. Mic... | Technical Support Bulletin issued in February 2013 did not mention performance limitation for Proteus mirabilis and Imp when using the CLSIM100-S20 revised interpretive criteria. | Terminated | null | 2014-08-08 | 2015-05-06 | null | Approx ~(216240 boxes U.S. and 84249 boxes OUS) total | null | 2919016 | 3 | 0 | Voluntary Action Indicated (VAI) | 2015-03-11 | 0 | 0 | null | false | -1 | software | missing performance data |
Z-1387-2017 | device | Cook Inc. | Check-Flo Performer Introducer, Individual product is packaged in a Tyvek-film sterilizable outer pouch. Introducers are intended for introduction of balloons, closed and non-tapered end catheters or other diagnostic and interventional devices. | Devices using a specific hemostatic valve design, referred to as a blue valve or polyisoprene valve, have an increase in reports of blood loss associated with the devices which could result in delay in procedure and blood loss from patients. | Terminated | null | 2017-02-01 | 2017-03-08 | null | 884 | null | null | null | null | null | null | 0 | 0 | null | false | null | device_malfunction | valve blood leakage |
Z-1119-2023 | device | MEDLINE INDUSTRIES, LP - Northfield | Surgical convenience kits labeled as: a) CENTURION MEDICAL PRODUCTS CHEST TUBE INSERTION TRAY, Reorder Number CVI2105; b) CENTURION MEDICAL PRODUCTS VASECTOMY KIT, Reorder Number MNS11975; c) CENTURION MEDICAL PRODUCTS LACERATION TRAY, Reorder Number SUT11670; d) CENTURION MEDICAL PRODUCTS LACERATION TRAY, Reor... | The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile. | Ongoing | null | 2022-12-07 | 2023-02-22 | null | 2753 units | null | null | null | null | null | null | 0 | 0 | null | false | null | sterility | perforated packaging compromise |
D-0292-2018 | drug | Medline Industries Inc | Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060 | Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. | Terminated | null | 2017-09-21 | 2018-02-07 | Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey | 100 cases | null | 3019239304 | 1 | 0 | No Action Indicated (NAI) | 2024-11-04 | 0 | 0 | null | false | -1 | potency | subpotent iodine |
Z-1143-2022 | device | Baxter Healthcare Corporation | 5 Prong Manifold Set (with Luer Connectors) | Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error. | Ongoing | null | 2022-04-21 | 2022-06-08 | null | 180 units | null | 1416980 | 17 | 2 | Official Action Indicated (OAI) | 2024-08-01 | 1 | 1 | 2014-01-17 | false | -1 | null | null |
D-0228-2015 | drug | Oregon Compounding Centers, Inc. dba Creative Compounds | VITAMIN B COMPLEX (PRES) injectable, 100mg, 10 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070. | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. | Terminated | null | 2014-10-06 | 2014-11-12 | Oregon, Washington | 490 mL | null | null | null | null | null | null | 0 | 0 | null | false | null | sterility | quality control deficiency |
Z-1402-2021 | device | Siemens Healthcare Diagnostics, Inc. | ADVIA 2120i Refurb Single Aspirate (SMN 11314044) - OUS, 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 | 33 units | null | 2517506 | 4 | 1 | Voluntary Action Indicated (VAI) | 2014-04-23 | 1 | 1 | 2012-06-29 | false | 0 | software | barcode identification error |
Z-0661-2021 | device | Boston Scientific Corporation | IcePearl" 2.1 CX Cryoablation Needle | Complaint trend regarding needle shaft gas leaks. | Completed | null | 2020-11-18 | 2020-12-30 | null | 86 units | null | 3032507796 | 2 | 0 | No Action Indicated (NAI) | 2016-12-14 | 0 | 0 | null | false | 0 | device_malfunction | needle shaft leaks |
Z-2202-2014 | device | Gambro Renal Products, Incorporated | Prismaflex M100. Product number 106697. Each set is packaged in a plastic pouch, 4 pouches per carton box | Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood. | Terminated | null | 2014-07-18 | 2014-08-20 | null | 401,451 | null | 1713683 | 2 | 0 | No Action Indicated (NAI) | 2015-02-12 | 0 | 0 | null | false | -1 | device_malfunction | connector breakage |
D-0562-2021 | drug | Cardinal Health Inc. | Medroxyprogesterone acetate injectable suspension, USP 150 mg per mL 1 mL Prefilled Syringe Rx only NDC 59762-4538-2 Distributed by: Greenstone, LLC. Peapack, NJ 07977 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Terminated | null | 2021-03-15 | 2021-06-02 | FL, GA, SC | 286 syringes | null | 3003474118 | 3 | 0 | No Action Indicated (NAI) | 2025-02-19 | 0 | 0 | null | false | -1 | cGMP | temperature excursion |
Z-0577-2021 | device | Synthes (USA) Products LLC | DePuy Synthes 13.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.022S | RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniques are not followed | Terminated | null | 2020-11-19 | 2020-12-23 | null | 1447 US; 554 OUS | null | 3008812560 | 7 | 0 | Voluntary Action Indicated (VAI) | 2017-10-20 | 0 | 0 | null | false | 0 | device_malfunction | reamer head breakage |
Z-0765-2022 | device | Boston Scientific Corporation | JAGTOME REVOLUTION RX 39-20-260-025 Material Number: M00584240 | Sterility of device is compromised due to a sterile barrier breach | Ongoing | null | 2021-12-22 | 2022-03-23 | null | 7115 units | null | 3005099803 | 7 | 0 | Voluntary Action Indicated (VAI) | 2024-11-26 | 0 | 0 | null | false | -1 | sterility | barrier breach |
Z-0269-2023 | device | Beckman Coulter, Inc. | MicroScan autoSCAN-4 Instrument, Catalog Number B1018-280 | Due to MicroScan autoSCAN-4 Instruments being manufactured with an incorrect diffuser plate. | Ongoing | null | 2022-10-03 | 2022-11-30 | null | 53 plates | null | 3007448124 | 1 | 0 | No Action Indicated (NAI) | 2014-11-20 | 0 | 0 | null | false | 0 | device_malfunction | incorrect diffuser plate |
Z-0112-2025 | device | Boston Scientific Corporation | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO INT UPGRADE JAPAN; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anatomical information. The system can provide various modalities which includes intravascular ultrasound ... | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was connected to the AVVIGO+ Multi-Modality Guidance System while in either Live or Record mode. The Boston Scientific investigation determined t... | Ongoing | null | 2024-09-05 | 2024-10-23 | null | 1 unit | null | 3010178326 | 1 | 0 | Voluntary Action Indicated (VAI) | 2014-03-20 | 0 | 0 | null | false | 0 | software | grid overlay display |
D-758-2015 | drug | Attix Pharmaceuticals | Levofloxacin Hemihydrate 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. | 25606 grams | null | null | null | null | null | null | 0 | 0 | null | false | null | contamination | penicillin cross contamination |
D-1409-2019 | drug | P & L Developments, LLC | Cetirizine Oral Solution 1 mg/mL, Up & Up, Children's allergy relief, Antihistamine, Dye Free, Grape Flavor, 4 FL. oz. (118 mL) Bottle, Distributed by Target Corporation, Minneapolis, MN 55403, NDC 11673-178-04, UPC 359726178044. | cGMP Deviations: Firm was notified by their supplier of Cetirizine HCL Oral Solution, USP, 1mg/mL, 4oz, of the voluntary recall that they have initiated due to potential contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). | Terminated | null | 2019-06-05 | 2019-06-26 | Nationwide in the U.S. | 124,512 bottles | null | null | null | null | null | null | 0 | 0 | null | false | null | contamination | bacterial contamination |
Z-2027-2013 | device | Zimmer, Inc. | 00597603110 Articular Surface AC ART SURF 34/STRIPED YEL 10, Rx, Sterile; 00597603112 Articular Surface AC ART SURF 34/STRIPED YEL 12, Rx, Sterile; 00597603110 Articular Surface AC ART SURF 34/STRIPED YEL 10, Rx, Sterile; 00597603110 Articular Surface AC ART SURF 34/STRIPED YEL 10, Rx, Sterile; 00597603110 ... | Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in combinations that are not approved (micro with standard). Includes CR Micro Femurs, Articular Surface, Patellae, instruments and provisionals combined with standard components. A March 2012 recall reiterated the proper comb... | Terminated | null | 2013-06-07 | 2013-08-28 | null | 192,355 all devices | null | 1000220733 | 10 | 4 | No Action Indicated (NAI) | 2022-07-27 | 0 | 0 | null | false | -1 | mislabeling | unapproved component combinations |
Z-1133-2018 | device | Boston Scientific Corporation | SpyScope DS Access and Delivery diagnostic biliary catheter, M00546600 | Certain lots of devices may have the working channel sleeve protruding from the camera cap which may result in injuries from minor tissue damage to significant bleeding. | Terminated | null | 2017-12-20 | 2018-03-28 | null | 5026 | null | 2124215 | 18 | 1 | Official Action Indicated (OAI) | 2025-04-07 | 0 | 0 | null | false | -1 | device_malfunction | protruding component |
Z-1047-2024 | device | Cardinal Health 200, LLC | Dover" HYDROGEL COATED LATEX 400 ML U/M FOLEY TRAY, LL, 14 FR (4.7 MM), 5 CC, 2000 ML DRAIN BAG, CSD; Dover" 100% SILICONE SILVER-HYDROGEL COATED 400ML U/M TEMP SENSE FOLEY TRAY, 16FR (5.3 MM), 5CC, CSD; Dover" 100% SILICONE SILVER-HYDROGEL COATED 400ML U/M TEMP SENSE FOLEY TRAY, 18FR (6.0 MM), 5CC, CSD; Dover" 100% S... | Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist. | Ongoing | null | 2023-12-04 | 2024-02-28 | null | 7800 units | null | 3004259653 | 2 | 0 | No Action Indicated (NAI) | 2018-01-18 | 0 | 0 | null | false | 0 | other | recalled component recall |
Z-0769-2016 | device | GE Medical Systems, LLC | GE Healthcare, Brivo XR285amx Mobile Digital Ready Radiographic System Designed to generate diagnostic radiographic images. | Potential safety latch mechanism failure. The safety latch, within the column that supports the horizontal arm, is a backup in the unlikely event the primary safety cable breaks. A fall of the arm assembly could result in bodily harm to a person. | Terminated | null | 2015-12-23 | 2016-02-17 | null | 126 | null | 2183553 | 3 | 0 | No Action Indicated (NAI) | 2012-10-11 | 0 | 0 | null | false | 0 | device_malfunction | safety latch failure |
D-1650-2012 | drug | Custom Medical Specialties, Inc. | CMS-8934 Custom Phlebectomy Tray, Sterile, contains Sodium chloride 0.9% 50 mL, Manufactured by: CMS, Custom Medical Specialties, Inc., 330 East Main St, PO Box 177, Pine level, NC 27568, the tray also contains other components not listed in this product description. | Lack of Assurance of Sterility; the firm's medical trays contain Hospira's 0.9% Sodium Chloride bags which were subject to recall due to leaking bags. | Terminated | null | 2012-07-23 | 2012-08-29 | GA, MD, MA | 20 Trays | null | 3005474845 | 2 | 0 | No Action Indicated (NAI) | 2013-08-08 | 0 | 0 | null | false | -1 | sterility | leaking bags |
Z-0699-2014 | device | ICU Medical, Inc. | 120" 10 Drop Primary Set w/2 BCV-CLAVE¿, Remv 2 Gang CLAVE¿ Stopcock, Remv CLAVE¿ Stopcock, NanoClave¿ T-Connector, Rotating Luer, 2 Ext, Part No. A1000, Item No. SC125 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set f... | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. | Terminated | null | 2013-12-24 | 2014-01-15 | null | 2000 units | null | 3013319212 | 8 | 2 | No Action Indicated (NAI) | 2024-09-09 | 2 | 2 | 2013-05-09 | false | -1 | device_malfunction | connector leakage |
D-1045-2020 | drug | Noven Therapeutics, LLC | Daytrana (methylphenidate transdermal system) patches, Delivers 30 mg over 9 hours (3.3 mg/hr), 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC. Miami, FL 33186, NDC 68968-5555-3 | Defective Delivery System: Out of specification for mechanical peel and shear. | Terminated | null | 2020-03-02 | 2020-03-25 | U.S.A. Nationwide | 7469 boxes | 68968-5552 | null | null | null | null | null | 0 | 0 | null | false | null | device_malfunction | defective delivery system |
D-0839-2020 | drug | Akorn Inc | Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL dropper bottle, Rx only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701; NDC 50383-901-10. | Subpotent Drug: Low Out of specification (OOS) assay results for the hydrocortisone portion of this product. | Terminated | null | 2019-12-16 | 2020-02-19 | Nationwide in the USA and Puerto Rico | 16,078 bottles | null | 3008883167 | 1 | 0 | No Action Indicated (NAI) | 2015-11-10 | 0 | 0 | null | false | 0 | potency | subpotent API |
Z-0195-2024 | device | Siemens Medical Solutions USA, Inc | Siemens Cios Alpha (VA30) mobile fluoroscopic C-arm X-ray System, designed for the surgical environment. 11105200 | Software issue for Cios Alpha, Cios Flow, and Cios Spin VA30 systems, fulfillment of new requirements from DIN and IEC standards for Cios VA30 systems required may result in patient misdiagnosis/repeat exposure | Ongoing | null | 2023-09-12 | 2023-11-08 | null | 237 units | null | 2240869 | 3 | 0 | Voluntary Action Indicated (VAI) | 2022-10-26 | 0 | 0 | null | false | 0 | software | standards compliance update |
D-1520-2022 | drug | Carolina Infusion | Semaglutide/Cyanocobalamin 10/2 MG/ML Injectable, 0.4 ML syringe, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936. | Lack of Assurance of Sterility | Completed | null | 2022-08-26 | 2022-09-21 | Nationwide in the USA. | 4 syringes | null | 3015826782 | 2 | 2 | Official Action Indicated (OAI) | 2025-01-24 | 1 | 1 | 2023-06-09 | false | -1 | sterility | lack of assurance |
Z-1798-2015 | device | Biomet, Inc. | Vanguard M Unicondylar Tibial Trial For use during knee joint replacement. | The Left and Right orientation of the trial was incorrectly etched on one side. When the instrument is rotated about the axis of the handle 180 degrees to view the other side, the etch on the handle now shows R on the same side as the keel marked LM and the L on the same side as the keel marked RM. This is incorrect.... | Terminated | null | 2015-04-22 | 2015-06-24 | null | 27 | null | 1825034 | 7 | 0 | Voluntary Action Indicated (VAI) | 2023-11-09 | 2 | 2 | 2018-08-24 | false | -1 | device_malfunction | incorrect orientation marking |
Z-1844-2017 | device | Smith & Nephew, Inc. | Smith & Nephew ACUFEX TRUNAV Retrograde Drill 8.5MM Product Number: 72204043 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone | Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming | Terminated | null | 2017-03-15 | 2017-04-26 | null | N/A | null | 3006760724 | 4 | 1 | Voluntary Action Indicated (VAI) | 2015-01-13 | 1 | 1 | 2014-06-11 | false | 0 | device_malfunction | blade detachment fracture |
Z-0094-2023 | device | SIEMENS HEALTHCARE DIAGNOSTICS INC | N Antiserum to Human IgG, 5mL Variant for BN II System and BN ProSpec System- IVD Siemens Material Number (SMN): 10446299 | N Antiserum to Human IgG are not meeting the current High-Dose Hook Effect expectation of up to 648 mg/L for IgGU (urine) and up to 2290 mg/L for IgGC (CSF). | Ongoing | null | 2022-08-30 | 2022-10-26 | null | 10,201 packs | null | 1824828 | 3 | 0 | No Action Indicated (NAI) | 2017-11-09 | 0 | 0 | null | false | 0 | potency | insufficient antiserum reactivity |
D-0149-2021 | drug | BASF Corporation | Kollidon CL-M Crospovidone Ph.Eur.Type B, USP/NF, JP, micronized, packaged in 30 kg plastic drums, Manufacturer: BASF SE, Carl-Bosch-Strabe 38, 67056 Ludwigshafen, Germany, Co-Manufactured by Siegfried PharmaChemikalien Minden GmbH, D-32423 Minden | Cross contamination: the excipient was found to be contaminated with theophylline. | Completed | null | 2020-11-17 | 2020-12-23 | USA Nationwide and Worldwide | 4560 kg | null | 3003165270 | 2 | 0 | No Action Indicated (NAI) | 2024-12-04 | 0 | 0 | null | false | -1 | contamination | excipient cross contamination |
Z-0851-2026 | device | Philips North America Llc | IntelliVue MP20. Product Number: M8001A. | Potential issue where the IntelliVue monitors did not alarm. | Ongoing | null | 2025-10-31 | 2025-12-10 | null | 1,913,441 units | null | 1000524572 | 10 | 2 | Voluntary Action Indicated (VAI) | 2022-10-27 | 2 | 1 | 2017-10-31 | false | 0 | device_malfunction | alarm failure |
D-308-2016 | drug | Kalman Health & Wellness, Inc. dba Essential Wellness Pharma | HCG 2000 Units/mL Injection, packaged in a) 4 mL and b) 15 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. | Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs. | Terminated | null | 2015-09-03 | 2015-11-25 | Nationwide | 2 vials | null | null | null | null | null | null | 0 | 0 | null | false | null | sterility | poor production practices |
D-0425-2023 | drug | Accord Healthcare, Inc. | rOPINIRole Tablets USP 0.25 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA. NDC 16729-232-01, UPC 3 16729 23201 2; | CGMP Deviations: recalling drug products following an FDA inspection. | Terminated | null | 2023-02-07 | 2023-03-08 | United States including Puerto Rico and Canada | 139,332 bottles | 16729-232 | 3007518432 | 4 | 0 | No Action Indicated (NAI) | 2017-01-19 | 0 | 0 | null | false | 0 | cGMP | inspection deviations |
Z-0555-2020 | device | Boston Scientific Corporation | Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 10cm UPN: M005336680 | Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life | Terminated | null | 2019-10-21 | 2019-12-04 | null | 222 units | null | 2124215 | 18 | 1 | Official Action Indicated (OAI) | 2025-04-07 | 0 | 0 | null | false | -1 | mislabeling | incorrect shelf life |
D-1120-2016 | drug | Reliable Rexall-A Compounding Pharmacy | All acyclovir and lidocaine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122. | Lack of Processing Controls | Terminated | null | 2016-03-25 | 2016-07-13 | U.S. Including: CA, HI, NM | N/A | null | 3006164918 | 1 | 1 | Official Action Indicated (OAI) | 2016-03-29 | 1 | 1 | 2017-03-10 | false | -1 | cGMP | processing controls |
Z-1602-2013 | device | Baxter Healthcare Corp. | Brand Name: Regional Analgesia Infusor System with Patient Control. Indicated for the intravenous administration of medications. | Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products listed above due to an increase in rupture complaints. Baxter has implemented product and process improvements which have substantially improved product quality. Complaint rates for ruptures have since decreased. Baxter wants t... | Terminated | null | 2013-06-07 | 2013-07-03 | null | 3,255,096 total | null | null | null | null | null | null | 0 | 0 | null | false | null | device_malfunction | rupture defect |
Z-1538-2014 | device | Biorep Technologies | Joseph Lamelas Atrial Lift System, Model Number MI-ALS-001. A single surgical instrument or tool for retraction of the atrial wall tissue in cardiac surgery. | The support arm attached with an adhesive to the body of the blade is detaching while attempting to engage the visor component. | Terminated | null | 2014-03-19 | 2014-05-14 | null | 80 boxes (480 units) | null | null | null | null | null | null | 0 | 0 | null | false | null | device_malfunction | adhesive failure detachment |
Z-2980-2017 | device | Valorem Surgical LLC | PALLAS M/MAXIMIS Dilator B. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine. | Devices are not consistent with Quality System Requirements. | Terminated | null | 2017-06-21 | 2017-08-16 | null | 262 units total | null | 3010212187 | 2 | 1 | Official Action Indicated (OAI) | 2016-10-26 | 0 | 0 | null | true | 0 | cGMP | quality system compliance |
Z-3386-2018 | device | B. Braun Medical, Inc. | GOVCE17TKFC EPIDURAL TRAY W/ 17GA TUOHY, Material Number 332602 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous admi... | The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed. | Terminated | null | 2018-07-20 | 2018-10-10 | null | 1020 | null | 2523676 | 11 | 0 | Voluntary Action Indicated (VAI) | 2025-05-16 | 0 | 0 | null | false | -1 | device_malfunction | connector failure |
D-1158-2015 | drug | Lincare, Inc. | TPN 2:1, 200 ml Bags, Qty: 7, Base Formula NaCl 0.9%, Dextrose 70%, Trophamine 10%, Water for Inj; Electrolytes Calcium Gluc, MgSO4, Na Phos, KCL; Vitamins, trace elements and medications Copper Cl, Selenium, Zinc Sulfate, Infuvite Pediat, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman... | Lack of Assurance of Sterility: Sterility of product is not assured. | Terminated | null | 2015-05-28 | 2015-07-08 | United States including: Arkansas | 7 Bags | null | 1031031 | 1 | 0 | No Action Indicated (NAI) | 2011-05-04 | 0 | 0 | null | false | 0 | sterility | lack of sterility assurance |
D-410-2014 | drug | Specialty Medicine Compounding Pharmacy | Acetylcysteine (PF) 20 % Opthalmic, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 | Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured. | Terminated | null | 2013-10-19 | 2014-01-22 | Hospitals, clinics, physicians, and patients in the Michigan area only. | 20 mL | null | null | null | null | null | null | 0 | 0 | null | false | null | sterility | non-sterile environment |
Z-0831-2024 | device | American Contract Systems, Inc. | Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) LavH, kit number BBLV21C; b) LAP HYST 247540, kit number BFHY75U | During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There is no supporting documentation stating the "piggybacked" components were assessed to determine if they were suitable for exposure to elevated temperatures for an... | Ongoing | null | 2023-11-29 | 2024-02-07 | null | 144 units | null | 3003368406 | 3 | 0 | Voluntary Action Indicated (VAI) | 2017-05-11 | 0 | 0 | null | false | 0 | device_malfunction | sterilization damage |
D-317-2014 | drug | Main Street Family Pharmacy, LLC | Triamcinolone Acetonide 40mg/ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200 | The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. | Terminated | null | 2013-05-28 | 2013-12-11 | nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV | 66 units | null | 3010199183 | 1 | 1 | Official Action Indicated (OAI) | 2013-06-11 | 0 | 0 | null | false | -1 | sterility | bacterial contamination |
Z-0874-2018 | device | Bausch & Lomb Inc Irb | LASEREDGE Knives, 2.65MM SLIT KNIFE ANGLED DOUBLE BEVEL GUARDED (6/BOX), REF/PRODUCT CODE E7551ADBG, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to surgeons for use in procedures. | The complaints database was reviewed and there have been an atypical volume of dull blades complaints for various lots. out of an abundance of precaution, Bausch + Lomb is voluntarily recalling all product codes SKU manufacturing without the electro-polish control and penetration force testing. | Terminated | null | 2017-03-03 | 2018-03-14 | null | 1,236,749 knives in total | null | null | null | null | null | null | 0 | 0 | null | false | null | device_malfunction | dull blades |
Z-3135-2024 | device | Datascope Corp. | CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons. | Firm has developed a software correction (Revision D.00) outside the US to mitigate product problems that pose a risk of hemodynamic instability and failure of transmission of clinical data in Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump devices. | Ongoing | null | 2024-08-08 | 2024-10-02 | null | 5,475 units | null | 3007965489 | 2 | 2 | Official Action Indicated (OAI) | 2023-06-15 | 1 | 0 | 2015-02-03 | true | 0 | software | hemodynamic instability risk |
Z-2439-2012 | device | Covidien LP | Covidien Duet TRS 60 4.8 mm Universal Articulating Single Use Loading Unit. Product Code: DUET6048A. Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal, gynecologic and pediatric surgery for resection, transection and cre... | Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications. | Terminated | null | 2012-08-21 | 2012-10-03 | null | 135,712 units | null | 1282497 | 8 | 0 | Voluntary Action Indicated (VAI) | 2022-11-18 | 0 | 0 | null | false | -1 | device_malfunction | injury risk design |
D-1191-2015 | drug | Lincare, Inc. | Vancomycin HCl, Vancomycin 1500mg / D5W 265mL, Qty: 2 265 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200. | Lack of Assurance of Sterility: Sterility of product is not assured. | Terminated | null | 2015-05-28 | 2015-07-08 | United States including: Arkansas | 2 Bags | null | 3006426734 | 1 | 0 | No Action Indicated (NAI) | 2013-09-12 | 0 | 0 | null | false | 0 | sterility | inadequate assurance |
Z-0875-2014 | device | Synergetics Inc | Chandelier Infusion Cannula, Synergetics, inc., 20ga, length 7.5 ft, sterile / EO, 56.30.P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO. | Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure. | Terminated | null | 2013-12-09 | 2014-02-05 | null | 108 units | null | 1000119053 | 4 | 0 | No Action Indicated (NAI) | 2017-11-16 | 0 | 0 | null | false | -1 | device_malfunction | faulty outer pouch seal |
Z-1464-2019 | device | Zimmer GmbH | V-TEK", micro-countersink, round shaft, Item Number 28.66.112 | An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications. | Terminated | null | 2019-04-08 | 2019-05-29 | null | N/A | null | 3005233524 | 1 | 0 | No Action Indicated (NAI) | 2010-02-26 | 0 | 0 | null | false | 0 | cGMP | unapproved material |
D-1143-2020 | drug | Herbal Doctor Remedies | Max Slim, 500mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808 | CGMP Deviations: These products have been found to be misbranded as unapproved new drugs | Terminated | null | 2020-03-24 | 2020-04-15 | Products are sold online within the United States and internationally to the following countries: Australia, Canada, Israel, Italy, Japan, Norway, and United Kingdom | N/A | null | 3003040962 | 3 | 1 | No Action Indicated (NAI) | 2018-05-22 | 2 | 2 | 2019-10-04 | false | 0 | cGMP | unapproved drug misbranding |
Z-0506-2020 | device | Cook Inc. | Pneumothorax Tray, Catalog No. C-UTPTY-1400-WAYNE-112497-IMH, GPN G56537 - Product Usage: The modified Wayne Pneumothorax Set is used for the relief of simple, spontaneous, iatrogenic, and tension pneumothorax. | Lidstock perforation line may be over the sterile area of the tray, when it should be on the lip of the tray, potentially compromising the sterility of the device. | Terminated | null | 2019-09-17 | 2019-11-27 | null | 41 units | null | null | null | null | null | null | 0 | 0 | null | false | null | sterility | lidstock perforation placement |
D-1052-2022 | drug | Mckesson Medical-Surgical Inc. Corporate Office | Xylocaine + Epinephrine, multi dose vial 1%, packaged in a) 20 mL, 25-count box (NDC 63323-482-27) b) 50 mL, 25-count box (NDC 63323-482-57), Rx only, MFG: Fresenius Kabi USA LLC | cGMP deviations: Temperature abuse | Terminated | null | 2022-04-13 | 2022-06-15 | USA nationwide. | 76 trays/25 vials per tray | 63323-481 | null | null | null | null | null | 0 | 0 | null | false | null | cGMP | temperature abuse |
Z-1762-2024 | device | Angiodynamics, Inc. | DURAFLOW 2, 32CM STRAIGHT BASIC KIT PG-Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103012035 | Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure. | Ongoing | null | 2024-03-18 | 2024-05-15 | null | 35 units | null | 3017892510 | 10 | 0 | No Action Indicated (NAI) | 2021-06-25 | 0 | 0 | null | false | 0 | foreign_material | metal shavings |
Z-0513-2023 | device | Stradis Medical, LLC dba Stradis Healthcare | HENRY SCHEIN, VEIN TRAY, Item No.570-2738, | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit. | Ongoing | null | 2022-11-02 | 2022-12-21 | null | 18 units | null | 1000111025 | 6 | 1 | No Action Indicated (NAI) | 2021-08-05 | 1 | 1 | 2011-08-15 | false | 0 | sterility | incomplete seal breach |
Z-2144-2021 | device | CooperVision Inc. | AQUATECH PLUS 1 DAY TORIC Power: -07.50 -0.75/060 Daily Disposable Contact Lens with UV blocker | Misaligned placement of an axis mark can cause the patient to experience blurred vision | Terminated | null | 2021-05-19 | 2021-08-04 | null | 720 lenses | null | null | null | null | null | null | 0 | 0 | null | false | null | device_malfunction | misaligned axis mark |
D-872-2013 | drug | Pallimed Solutions | MIC with B6 and B12, compounded by Pallimed Solutions Pharmacy, Woburn, MA | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance | Terminated | null | 2013-03-25 | 2013-08-21 | Nationwide | 18 vials | null | null | null | null | null | null | 0 | 0 | null | false | null | sterility | QC procedure deficiency |
Z-2351-2019 | device | Siemens Medical Solutions USA, Inc. | ACUSON NX2 Elite Diagnostic Ultrasound System, Model # 11284500, RX Only, Siemens Medical Solutions, containing software version VA10A, VA10B, VA11A, VA11B; UDI # 04056869050775 The ACUSON NX2 diagnostic ultrasound imaging systems are intended for the following applications: Cardiac, Fetal, Abdominal (including liv... | The action is being initiated due to internal testing which identified a possibility for transducers to exceed the acoustic output power (AOP) values defined . The transit voltage values based on PW Doppler are calculated normally but not loaded correctly into hardware | Ongoing | null | 2019-01-28 | 2019-08-28 | null | 70 systems | null | 3006365753 | 3 | 0 | No Action Indicated (NAI) | 2019-06-06 | 0 | 0 | null | false | -1 | software | output power calculation |
D-0720-2020 | drug | Assurance Infusion | CJC-1295 2000 mcg/Ipamorelin 2000 mcg/mL Inj. in 2 mL vial Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Terminated | null | 2019-12-20 | 2020-01-22 | Nationwide within the United States | 19 vials | null | 3015617746 | 1 | 1 | Official Action Indicated (OAI) | 2019-12-03 | 1 | 1 | 2020-06-12 | true | 0 | sterility | assurance failure |
Z-1112-2024 | device | MEDLINE INDUSTRIES, LP - Northfield | Medline Kits, trays, and packs labeled as follows: a) LACERATION KIT, REF SUT13935; b) LACERATION TRAY, REF SUT21215; c) LACERATION TRAY, REF SUT15380; d) LACERATION TRAY W/SNAGFREE NEE, REF SUT19005; e) PLASTICS SUTURE TRAY, REF SUT13535; f) UVC INSERTION TRAY, REF UVT840A g) BRONCHOALVEOLAR LAVAGE PACK,... | Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result ... | Ongoing | null | 2023-11-15 | 2024-03-06 | null | 21154 units | null | null | null | null | null | null | 0 | 0 | null | false | null | sterility | non-sterile solution |
Z-1880-2014 | device | The Anspach Effort, Inc. | ANSPACH***REF 98-0001***eMax Hand Control***Rx Only*** This device is intended to be used with Anspach Systems | The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements. | Terminated | null | 2012-11-28 | 2014-07-02 | null | 3 | null | 1045834 | 4 | 0 | Voluntary Action Indicated (VAI) | 2015-02-06 | 0 | 0 | null | false | -1 | cGMP | quality system non-compliance |
D-0024-2017 | drug | Teva Pharmaceuticals USA | Amikacin Sulfate Injection, USP, 1 gm/4 mL (250 mg/mL) Rx Only, Manufactured in Hungary For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-9040-01 (individual pack), NDC 0703-9040-03 (shelf-pack carton of 10 vials). | CGMP Deviations | Terminated | null | 2016-07-29 | 2016-10-19 | Nationwide and Puerto Rico | 11,844 vials | null | null | null | null | null | null | 0 | 0 | null | false | null | cGMP | CGMP deviations |
Z-3278-2024 | device | Boston Scientific Corporation | WALLFLEX ESOPHAGEAL FC 23/28MMX10CM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas Material Number (UPN): M0051... | WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. | Ongoing | null | 2024-08-01 | 2024-10-02 | null | 364 units | null | 2183460 | 6 | 0 | No Action Indicated (NAI) | 2016-02-24 | 0 | 0 | null | false | 0 | device_malfunction | catheter tip detachment |
Z-0623-2019 | device | Clark Laboratories, Inc. (dba,Trinity Biotech USA) | Genesys 2 Reagent, REF 01-03-0022 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion exchange chromatography. For in vitro diagnostic use only. | lack of 510K | Terminated | null | 2018-11-01 | 2018-12-26 | null | 216 units | null | null | null | null | null | null | 0 | 0 | null | false | null | cGMP | missing regulatory clearance |
D-218-2014 | drug | Main Street Family Pharmacy, LLC | Methylprednisolone 40mg w/lidocaine 1ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200 | The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. | Terminated | null | 2013-05-28 | 2013-12-11 | nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV | 247 units | null | 3010199183 | 1 | 1 | Official Action Indicated (OAI) | 2013-06-11 | 0 | 0 | null | false | -1 | sterility | bacterial contamination |
Z-2562-2023 | device | Landauer | nanoDot D2DNS, Model Numbers: a) 18100-000; b) 18100-1MO; c) 18100-2MO; d) 18100-KIT; radiation monitoring dosimeter used with the microSTAR readers | LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDots indicated the presence of a potential non-conformance in the Optical Stimulated Luminescence (OSL) material that is beamed after exposure and emits fluorescence propor... | Completed | null | 2023-07-12 | 2023-09-20 | null | 211815 units | null | 3008426232 | 1 | 0 | No Action Indicated (NAI) | 2021-12-16 | 0 | 0 | null | false | 0 | device_malfunction | accuracy deviation |
Z-1579-2022 | device | Baxter Healthcare Corporation | Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Green: a) 25 pack, REF H93869025, b) 100 pack, REF H938674100, c) 100 pack, REF H93869100 | There is a potential of the packaging not maintaining a sterile barrier for the tip caps. | Ongoing | null | 2022-07-22 | 2022-08-31 | null | 168390 units | null | 1416980 | 17 | 2 | Official Action Indicated (OAI) | 2024-08-01 | 1 | 1 | 2014-01-17 | false | -1 | sterility | compromised barrier integrity |
Z-0775-2021 | device | Boston Scientific Corporation | AXIOS Stent and Electrocautery - Enhanced Delivery System 20mm x10mm UPN: M00553660 - Product Usage: The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or walled-off necrosis resolution. | The rotating luer fitting at the distal end of the delivery system handle may become detached from the nose of the delivery during device preparation, stent delivery or use, resulting in delay or procedure or risk of peritonitis developing from leakage of enteric, pseudocyst, or biliary contents into the peritoneal ... | Terminated | null | 2020-12-01 | 2021-01-13 | null | 38 units | null | 1000120754 | 3 | 0 | Voluntary Action Indicated (VAI) | 2014-10-09 | 0 | 0 | null | false | 0 | device_malfunction | luer fitting detachment |
Z-3301-2018 | device | Olympus Corporation of the Americas | Bronchovideoscope BF-Q180 | The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel port. | Terminated | null | 2018-08-08 | 2018-10-10 | null | 5845 | null | 2429304 | 5 | 1 | No Action Indicated (NAI) | 2019-09-26 | 1 | 1 | 2012-09-10 | false | -1 | device_malfunction | port loosening risk |
Z-1300-2021 | device | Cardinal Health 200, LLC | In-View Clear Leggings Sterile | Cardinal Health has determined that a manufacturing variance in a plastic film used to manufacture these products is causing the drapes and leggings to stick , which may prevent the products from being unfolded and applied properly. | Terminated | null | 2021-02-25 | 2021-03-31 | null | 28417 units | null | 3004335638 | 2 | 0 | No Action Indicated (NAI) | 2022-06-27 | 0 | 0 | null | false | -1 | packaging | plastic film defect |
D-0250-2019 | drug | Kadesh International | puriton EYE RELIEF DROPS, 0.5 oz (15 ml) bottle, Kadesh Inc., NDC#7079600115, UPC 7 36972 16799 0. | Non-Sterility: Product manufactured under non-sterile production conditions. | Terminated | null | 2018-11-05 | 2018-11-21 | Product was distributed via online stores and retail distributors Nationwide in the USA, Uruguay, Canada, China, Dominican Republic, Korea, and Vietnam. | 18,521 bottles | null | 3003832984 | 2 | 1 | No Action Indicated (NAI) | 2021-07-15 | 1 | 1 | 2019-05-02 | false | -1 | sterility | non-sterile manufacturing |
Z-1454-2021 | device | BIOTRONIK Inc | BIOTRONIK INVENTRA 7, HF-T QP DF4 IS4, REF 393012, UDI: 04035479129286 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias. | There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds) | Terminated | null | 2021-03-08 | 2021-04-28 | null | 702 UNITS | null | 1028232 | 3 | 0 | No Action Indicated (NAI) | 2014-03-07 | 0 | 0 | null | false | 0 | device_malfunction | premature battery depletion |
D-1173-2015 | drug | Lincare, Inc. | CEFTRIAXONE SODIUM 2000mg / NS 50mL, Qty:4 50 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200. | 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 | 3006538765 | 1 | 0 | No Action Indicated (NAI) | 2012-08-30 | 0 | 0 | null | false | 0 | sterility | lack of assurance |
Z-0090-2014 | device | Carestream Health, Inc. | DRX Revolution Mobile X-Ray System, Model DRXR-1, Verona Street Rochester, NY 14608 Catalog Numbers 1019397, 1023415, 1023423 --- Made in USA by Carestream Health, Inc. 150 The device is designed to perform radiographic x-ray examinations on all pediatric and adult patients, in all patient treatment areas. | During an audit, Carestream discovered a DRX-1 System that captured an image which displayed an artifact. This issue was discovered in manufacturing. It occurs when the DRX product console software is updated to v5.6b software and the detector is not calibrated before use. | Terminated | null | 2013-07-26 | 2013-11-06 | null | 23 units installed total (11 domestically & 12 internationally) | null | 1317307 | 5 | 0 | No Action Indicated (NAI) | 2022-10-20 | 0 | 0 | null | false | -1 | software | calibration software bug |
Z-2329-2024 | device | Cardinal Health 200, LLC | Presource kits and trays, labeled as: 1) Cardiovascular Procedure Kit, Catalog Number SAN29ANCC3; 2) Cardiovascular Procedure Kit, Catalog Number SAN29ANCC4; 3) Cardiovascular Procedure Kit, Catalog Number SAN29ANCCL; 4) Cardiovascular Procedure Kit, Catalog Number SAN29ANCCM; 5) Cardiovascular Procedure Kit, Cat... | Cardinal Health is following the FDA's recommendations regarding the disposition of affected Jiangsu Shenli Medical Production Co. Ltd (Shenli) Syringes in the Merit Medical¿ supplied finished kits. Merit Medical¿ supplied finished kits are included as components in Presource kits. According to the FDA s communication,... | Ongoing | null | 2024-05-29 | 2024-07-17 | null | 17445 units | null | 3002973487 | 3 | 0 | No Action Indicated (NAI) | 2015-07-20 | 0 | 0 | null | false | 0 | device_malfunction | design modification |
Z-0178-2019 | device | Siemens Medical Solutions USA, Inc. | Biograph mCT: a) S(64)-3R, Material Number 10248669 b) S (20) -3R, Material Number 10507786 c) Flow 20-4R, Material Number 10528958 d) m Flow 64-4R, Material Number 10529161 e) mCT S(40)-4R, Material Number 10248671 f) mCT S(64)-4R, Material Number 0248672 g) mCT S(20)-3R, Material Number 10534159 h) mCT ... | The terminals on the plug may become loose and overheat. | Terminated | null | 2018-09-28 | 2018-10-24 | null | 890 units | null | 3006365753 | 3 | 0 | No Action Indicated (NAI) | 2019-06-06 | 0 | 0 | null | false | -1 | device_malfunction | loose terminals overheating |
Z-2548-2019 | device | Musculoskeletal Transplant Foundation, Inc. | QuickGraft¿ Model # 430PST | Measurement listed on the label is not taken under tension, and this would cause possible extension of surgical time needed to complete the procedure. | Terminated | null | 2019-08-15 | 2019-10-02 | null | 9 Qty | null | 3003370891 | 1 | 0 | No Action Indicated (NAI) | 2013-01-10 | 0 | 0 | null | false | 0 | mislabeling | incorrect measurements |
Z-1332-2026 | device | Medline Industries, LP | Medline medical convenience kits packaged as: SUTURE REMOVAL TRAY, Kit SKU DYNDR1277A | Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators. | Ongoing | null | 2025-12-24 | 2026-02-18 | null | 2448 kits | null | 3015274459 | 1 | 0 | No Action Indicated (NAI) | 2026-01-05 | 0 | 0 | null | false | -1 | packaging | open seal |
Z-1454-2020 | device | Cardinal Health 200, LLC | Monoject Hypodermic Safety Needle 30G X 1/2" Item Code 1183005 - Product Usage: used for general purpose injection and aspiration of fluids from vials, ampules and parts of the body below the surface of the skin. | Non-sterile product was shipped to customers. Product package is labeled as both "STERILE" and "NON-STERILR" ; the product did not undergo sterilization process and is non-sterile. The usage of a needle that is not sterile could result in infection. Firm is not aware of any reports of patient harm. | Terminated | null | 2020-01-15 | 2020-03-18 | null | 8000 | null | 3030940002 | 1 | 0 | No Action Indicated (NAI) | 2025-10-30 | 0 | 0 | null | false | -1 | sterility | non-sterile product |
D-0544-2025 | drug | Pfizer Inc. | Bicillin L-A (penicllin G benzathine injectable suspension), 1,200,000 units per 2 mL, 2 mL-vial, Rx Only, Distributed by Pfizer Inc., New York, NY 10001. Made in Austria, Carton NDC - 60793-701-10, Syringe NDC - 60793-701-02 | CGMP Deviations; particulates identified during visual inspection | Ongoing | null | 2025-07-10 | 2025-08-06 | Nationwide in the USA | 50,855 2 mL vials | 60793-700 | 2416101 | 5 | 1 | No Action Indicated (NAI) | 2022-07-22 | 2 | 2 | 2012-05-24 | false | 0 | cGMP | particulate matter |
Z-0771-2019 | device | Varian Medical Systems, Inc. | Eclipse(TM) Treatment Planning System with Proton Convolution Superposition algorithm license only The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, elec- tron ... | There is an anomaly with the Eclipse(TM) Treatment Planning System [TPS] Proton Convolution Superposition [PCS] dose calculation algorithm. The PCS algo- rithm calculates the water equivalent range incorrectly for non-square 3D CT images (either different number of pixels in X and Y, or non-square pixels). Before the... | Terminated | null | 2018-12-26 | 2019-01-30 | null | 1450 devices | null | 3000206172 | 4 | 0 | No Action Indicated (NAI) | 2022-09-07 | 0 | 0 | null | false | -1 | software | dose calculation algorithm |
D-0294-2023 | drug | Sentara Infusion Services | GANCICLOVIR ( CYTOVENE) (a)1480MG IN NS 296ML, (b) 740 MG IN NS 336 ML, antiviral, Rx Only, use with a Curlin pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320 | Lack of sterility assurance | Terminated | null | 2022-12-27 | 2023-02-22 | Dispensed to Patients Nationwide. | 5 bags | null | 3011627411 | 3 | 2 | Official Action Indicated (OAI) | 2022-12-16 | 1 | 1 | 2016-08-08 | true | 0 | sterility | lack of assurance |
D-0413-2015 | drug | Mylan Institutional LLC | Nicardipine Hydrochloride Injection, 25 mg/10 ml (2.5 mg/mL),10 mL single dose vial, Rx only, Manufactured in India for: Mylan Institutional LLC, Rockford, IL 61103, NDC 67457-224-10 | Subpotent Drug and Failed Impurities/Degradation Specifications | Terminated | null | 2015-01-23 | 2015-03-25 | Nationwide | 78,090 vials | null | null | null | null | null | null | 0 | 0 | null | false | null | potency | subpotent API |
Z-2433-2014 | device | Customed, Inc | OPEN HEART TRAY PACK A CONTENTS: (1) TABLE COVER BTC 77" X 110" HD FULL COVERAGE LIF (1) MAYO STAND COVER REINFORCED L/F (3) TOWEL ABSORBENT 15" X 20" LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (1) SPLIT SHEET BILATERAL 84" X 80" (12) % SHEET 60" X 77" DRAPE REINFORCED LIF (1) MAYO TRAY LARGE (1) CV D... | Customed has determined that there is the possibility that packaging integrity may be compromised on differ catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. | Terminated | null | 2014-05-20 | 2014-09-10 | null | 12 lots/88 units, multiple units per lot | null | null | null | null | null | null | 0 | 0 | null | false | null | packaging | compromised integrity |
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