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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
D-1103-2020 | drug | Avet Pharmaceuticals, Inc. | Losartan Potassium Tablets USP 50 mg, a) 30 count (NDC 23155-645-03), b) 90 count (NDC 23155-645-09) and c) 1000 count (NDC 23155-645-10) bottles, Rx only, Manufactured by: Vivimed Life Sciences Private Limited, Tamil Nadu, India, Manufactured for: Heritage Pharmaceutical Inc., East Brunswick, NJ 08816 NDC 23155-645-09 | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level | Terminated | null | 2020-03-26 | 2020-04-15 | Nationwide | a) 2,904; b) 14,316; c) 1,368 bottles | null | null | null | null | null | null | 0 | 0 | null | false | null | cGMP | impurity above limits |
Z-0704-2014 | device | ICU Medical, Inc. | 28" (71 cm) Appx 1.0 ml, Smallbore Ext Set w/Anti-Siphon Valve, MicroClave¿ T-Connector, Clamp, Rotating Luer, Item # B33071-T, Lot # 2791245. The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fl... | 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 | 50 | null | 2025816 | 2 | 0 | No Action Indicated (NAI) | 2017-07-14 | 0 | 0 | null | false | -1 | device_malfunction | leaking connector |
D-0319-2017 | drug | Tri-Coast Pharmacy | TriMix, Alprostadil/Phentolamine/Papaverine 40mcg/2mg/30mg/mL, (1 ML). Compounded by Tri-Coast Pharmacy | Lack of Assurance of Sterility | Ongoing | null | 2016-11-17 | 2017-01-11 | Nationwide | 17 vials | null | 3011827553 | 1 | 1 | Official Action Indicated (OAI) | 2016-10-21 | 1 | 1 | 2018-08-20 | true | 0 | sterility | sterility assurance failure |
Z-0667-2017 | device | Siemens Medical Solutions USA, Inc. | Z6Ms transesophageal transducers used on ACUSON SC2000 ultrasound systems, Z6Ms model 10436113. Radiology: The ACUSON SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transesophageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal... | Firm received reports about "acquisition errors" and the deterioration of material covering the articulating section of the Z6Ms transesophageal transducer. | Terminated | null | 2016-11-07 | 2016-12-07 | null | 33 | null | 3006365753 | 3 | 0 | No Action Indicated (NAI) | 2019-06-06 | 0 | 0 | null | false | -1 | device_malfunction | material deterioration |
Z-1036-2022 | device | American Contract Systems, Inc. | 1) ACS Spine Pack 2) ACS Lumbar/Back Set Up Tray | Product was sterilized with a higher than specification EO concentration. | Ongoing | null | 2022-03-22 | 2022-05-18 | null | 72 packs | null | 3003309947 | 5 | 1 | No Action Indicated (NAI) | 2025-04-17 | 0 | 0 | null | false | -1 | sterility | elevated EO residue |
Z-0755-2018 | device | Steris Corporation | Vis-U-All High Temp 3.5"x22" Heat Seal Pouch 200 pouches per box; 5 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclose and seal medical devices to be sterilized by steam. The pouch is designed to maintain sterility of properly proc... | On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of the ink onto the device(s) contained within the pouch. | Terminated | null | 2017-06-15 | 2018-03-07 | null | 17 | null | 1923569 | 4 | 0 | Voluntary Action Indicated (VAI) | 2022-03-31 | 0 | 0 | null | false | -1 | packaging | ink migration defect |
Z-1731-2013 | device | Terumo Cardiovascular Systems Corporation | CDI Blood Parameter Monitoring System 500 with Arterial blood parameter modules and Hematocrit/Saturation probe. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hematocrit, hemoglobin, and temperature are desired. | Terumo discovered through its own testing that CDI 500 Blood Parameter Monitoring System software contains inaccuracies associated with a software algorithm, and a software update has been developed to address this issue and a premarket notification (K130425) has been submitted to the agency. Once clearance is received... | Terminated | null | 2013-02-27 | 2013-07-24 | null | 3972 unit since 4/26/12 | null | 3000204839 | 6 | 0 | No Action Indicated (NAI) | 2024-02-16 | 0 | 0 | null | false | -1 | software | algorithm inaccuracy |
Z-2263-2018 | device | TriMed Inc. | Nitinol Staple, Elastic Staple Large-Symmetrical, Sterile R, Model #: a) ES-18x14; b) ES-20x20; c) ES-25x22 | During a retrospective review of sterilization records, TriMed has determined that evidence of quarterly dose audits/verification required to comply with the regulations could not be found. Sterilization records indicate that all lots of staples were irradiated to at least the defined dose. There is a risk that this ... | Terminated | null | 2018-04-13 | 2018-06-27 | null | 323 | null | 3001236812 | 5 | 1 | No Action Indicated (NAI) | 2019-08-14 | 1 | 1 | 2016-06-30 | false | -1 | sterility | sterilization documentation |
Z-1260-2021 | device | Smisson-Cartledge Biomedical, LLC | ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor 1200 Rapid Thermal Infusion System, used for infusion of: -crystalloid, colloid, or blood product, including packed red blood cells, as volume replacement for patients suffering from blood loss due to trauma or surgery -warmed f... | Customers are being notified of results from a Toxicological Risk Assessment related to potential for aluminum ions to leach into warmed fluids. | Terminated | null | 2021-02-18 | 2021-04-07 | null | 11768 devices | null | 3006158088 | 5 | 0 | No Action Indicated (NAI) | 2023-09-15 | 0 | 0 | null | false | -1 | contamination | aluminum ion leaching |
Z-0172-2024 | device | American Contract Systems, Inc. | LAVH, REF BBLV21C | 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 | 18 cases | null | 3003309947 | 5 | 1 | No Action Indicated (NAI) | 2025-04-17 | 0 | 0 | null | false | -1 | cGMP | improper sterilization process |
D-0447-2021 | drug | Cardinal Health Inc. | DEXAMETH SOD PHOS 0.1% 5ML; NDC/UPC 24208072002; RX; DROPS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Terminated | null | 2021-03-15 | 2021-06-02 | FL, GA, SC | 318 droptainers | null | 1000148701 | 3 | 0 | No Action Indicated (NAI) | 2020-02-19 | 0 | 0 | null | false | 0 | cGMP | temperature excursion |
Z-1832-2019 | device | Covidien LLC | SIGNIA TRI-STAPLE 2.0 30MM MEDIUM/ THICK RELOAD , SIG30AMT | The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax which can result in the potential for infection and/or sepsis. | Ongoing | null | 2019-05-17 | 2019-06-26 | null | 3,113,280 | null | 2936999 | 4 | 0 | No Action Indicated (NAI) | 2025-07-16 | 0 | 0 | null | false | -1 | device_malfunction | missing pin component |
Z-1442-2020 | device | CME America, LLC | BodyGuard Microset REF A120-003XYVA, Sterile EO, Tubing: 150 in. (380 cm), Prime Vol: approx. 8ml Product Usage: The BodyGuard Infusion Pump System is designed to transfer medication and fluids intravenously. | When using a specific tubing set with infusion pump system, may result in under deliver of fluids. | Terminated | null | 2019-09-16 | 2020-03-18 | null | 69400 infusion sets | null | 3006967710 | 5 | 0 | No Action Indicated (NAI) | 2018-04-23 | 0 | 0 | null | false | 0 | device_malfunction | under-delivery fluid |
D-723-2015 | drug | Attix Pharmaceuticals | Hydroxyurea 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. | 4250 grams | null | null | null | null | null | null | 0 | 0 | null | false | null | contamination | penicillin cross-contamination |
Z-1121-2026 | device | Baxter Healthcare Corporation | SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2 | Certain pumps have potentially been released from service with defective grease applied to the cam and motor gears. Due to its low viscosity, the defective grease may lead to the device having insufficient lubrication on the cam, which could lead to premature wear of the mechanism assembly, resulting in over-infusion o... | Ongoing | null | 2025-11-28 | 2026-01-28 | null | 585 units | null | 1019003 | 12 | 2 | No Action Indicated (NAI) | 2023-07-14 | 0 | 0 | null | false | 0 | device_malfunction | defective lubrication grease |
Z-2545-2025 | device | Quidel Corporation | QuickVue: Dipstick Strep A Test: 50T, REF: 20108; 25T, REF: 20125; 50T, SCN, REF: 20108SC | Dipstick strep A test has potential for false positive results. | Ongoing | null | 2025-06-17 | 2025-09-17 | null | 22470 | null | 2024674 | 2 | 0 | Voluntary Action Indicated (VAI) | 2017-04-10 | 0 | 0 | null | false | 0 | device_malfunction | false positive results |
D-0758-2023 | drug | Amerisource Health Services LLC | Glimepiride Tablets, USP, 2 mg, RX, Packaged as a ) 100-count bottle, NDC# 68001-178-00; b) 500-count bottle; NDC# 68001-178-03 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA. For BluePoint Laboratories | CGMP Deviations: recalling drug products following an FDA inspection. | Terminated | null | 2023-03-17 | 2023-05-31 | Nationwide USA | 105,361 bottles | null | 3000209995 | 7 | 0 | No Action Indicated (NAI) | 2022-05-27 | 0 | 0 | null | false | 0 | cGMP | inspection deviations |
Z-0845-2013 | device | Codman & Shurtleff, Inc. | NEUROPATH 5Fx100 GUIDING CATH HH Product Code: GHH51000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices | Sterility of device may be compromised due to lack of package integrity | Terminated | null | 2013-01-11 | 2013-02-27 | null | 50 units | null | null | null | null | null | null | 0 | 0 | null | false | null | sterility | compromised package integrity |
D-1219-2019 | drug | CMC Enterprise Pharmacy | Oxytocin 30 units in NS 500 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208. | Lack of sterility assurance. | Terminated | null | 2019-04-12 | 2019-05-01 | NC | 3690 bags | null | 3014539004 | 1 | 1 | Official Action Indicated (OAI) | 2019-03-22 | 1 | 1 | 2020-06-04 | true | 0 | sterility | lack of assurance |
D-0493-2017 | drug | Mylan Institutional, Inc. (d.b.a. UDL Laboratories) | Mirtazapine Tablets, USP, 45 mg. Rx only, 100 Tablets (10 X 10). Manufactured by: Mylan Pharmaceuticals Inc, Morgantown, WV ---NDC 51079-088-20 | Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablets commingled | Terminated | null | 2017-01-27 | 2017-03-15 | Nationwide | 58 UD100 Unit Dose Blister Cards of 10 (10 cards of 10 tablets each) | 51079-086 | null | null | null | null | null | 0 | 0 | null | false | null | foreign_material | commingled tablets |
Z-1935-2012 | device | Greiner Bio-One North America, Inc. | Vacuette Quickshield Complete Plus, 21G x 1 (0.8 x 25 mm), Greiner bio-one. The Quick shield Complete Plus is intended to be used only with Vacuette Blood collection Tubes as a system in routine venipuncture procedures. They are for single-use only and should only be used by adequately trained healthcare personnel ... | : The Quickshield Complete Plus may have a defect (split at the base), which can cause the green safety shield attachment of the Quickshield holder to be loose and unstable. | Terminated | null | 2012-04-02 | 2012-07-11 | null | 19.5 cases (5,850 pieces) and 244 cases (73,200 pieces)= 263.5 (73258 pieces total) | null | 3001451379 | 7 | 1 | No Action Indicated (NAI) | 2023-09-14 | 1 | 1 | 2020-04-16 | false | -1 | device_malfunction | split base defect |
Z-0875-2017 | device | Neusoft Medical Systems Co., Ltd. | NeuViz 64 Multi-slice CT Scanner Systems | The Firm discovered during contrast agent tracking scan, when the expected concentration of contrast agent is reached, later planned scan may be interrupted. The system must be powered down and restarted to clear the interruption error before scanning can resume. | Terminated | null | 2016-08-31 | 2017-01-04 | null | 23 units | null | 3003575350 | 5 | 0 | No Action Indicated (NAI) | 2019-01-24 | 0 | 0 | null | false | -1 | software | scanning interruption error |
Z-2974-2020 | device | Inpeco S.A. | Accelerator a3600 system with Sysmex XN-9000/XN-9100 Interface Module (dual robot) FLX-290-10; FLX-290-20 and Track to Rack Module FLX-295-10- Intended Clinical Chemistry Test Systems - Product Usage: The FlexLab 3.6 Automation is a modular system designed to automate Pre-Analytical and Post-Analytical processing, samp... | Firmware of the Sysmex XN-9000/XN-9100 Interface Module (IM) and of the Track to Rack Module has the potential to mis-associate sample IDs leading to incorrect results or delayed results | Terminated | null | 2020-08-07 | 2020-09-23 | null | 2 US and 6 OUS | null | null | null | null | null | null | 0 | 0 | null | false | null | software | sample ID association |
Z-1025-2016 | device | Karman Healthcare Inc | Karma Flexx Wheelchair Manual Wheelchair. | Karman Healthcare, Inc. is recalling Karma Flexx Wheelchair because incorrect size screws and corresponding hardware were installed on the front caster fork brackets. | Terminated | null | 2016-01-27 | 2016-03-09 | null | 35 | null | null | null | null | null | null | 0 | 0 | null | false | null | device_malfunction | incorrect hardware installation |
Z-2206-2019 | device | Integra LifeSciences Corp. | Codman ISOCOOL Bipolar Forceps-are indicated for cauterizing, coagulating, grasping, and manipulating tissue during general surgery, neurosurgery, ENT surgery, OB/GYN surgery, and maxillofacial / plastic surgery procedures. Model # 8145100S | Tips have an inadequate product insulation coating, which could result in the tips not coagulating as expected | Terminated | null | 2019-07-19 | 2019-08-14 | null | 125 units | null | null | null | null | null | null | 0 | 0 | null | false | null | device_malfunction | insulation coating defect |
Z-2193-2021 | device | Heartware, Inc. | HeartWare HVAD Driveline Extension Cable, REF 100US | Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational clinical comparisons that shows a higher frequency of neurological adverse events and mortality associated with the system when compared to other commercially available left ventricular assist devices, as well as c... | Ongoing | null | 2021-06-03 | 2021-08-18 | null | 443 units | null | 3010767211 | 2 | 1 | Voluntary Action Indicated (VAI) | 2017-07-21 | 0 | 0 | null | false | 0 | device_malfunction | pump restart failure |
Z-2484-2020 | device | Ortho Clinical Diagnostics | VITROS XT 7600 Integrated System Software Versions 3.5.1 and below Product Code:6844461 Unique Identifier: 10758750031610 | 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 | Total= 353 ( U.S.= 167; OUS 186) | null | null | null | null | null | null | 0 | 0 | null | false | null | software | parameter reset failure |
Z-1225-2023 | device | St. Jude Medical | CardioMEMS HF System PA Sensor and Delivery System, Model Number CM3100, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart failure (HF) patients. The system measures changes in PA pressure which physicians use to initiate or modify heart failure tre... | Select CardioMEMS PA Sensors (Model CM2000) operate outside of the intended frequency range at higher elevations when readings are taken over approximately 2,000 ft. (610 meters) above sea level; operation outside of the intended radiofrequency has the potential to result in inaccurate readings or sensor signal acquisi... | Ongoing | null | 2023-02-07 | 2023-03-15 | null | 317 units | null | 3008308852 | 1 | 0 | No Action Indicated (NAI) | 2010-04-19 | 0 | 0 | null | false | 0 | device_malfunction | altitude-related frequency drift |
D-0798-2018 | drug | Kroger Specialty Pharmacy, Inc. | OPDIVO 40 mg/4 mL SDV NDC 00003-3772-11 28 days supply | Lack of Processing Controls. | Terminated | null | 2018-04-03 | 2018-05-16 | MS, LA, AR, IL, FL | Unknown | null | null | null | null | null | null | 0 | 0 | null | false | null | cGMP | inadequate processing controls |
Z-1664-2015 | device | United Surgical Associates | Elastic Ankle Support. A limb orthosis (brace) is a device intended for medical purposes that is worn on the upper or lower extremities to support, to correct, or to prevent deformities or to align body structures for functional improvement. | The product does not bear the caution label regarding latex content. Potential for Allergic skin reaction | Terminated | null | 2015-04-13 | 2015-06-03 | null | 1278 | null | null | null | null | null | null | 0 | 0 | null | false | null | undeclared_allergen | latex allergen |
D-0021-2024 | drug | Central Admixture Pharmacy Services Inc | fentaNYL, 2500 mcg/50 mL, (50 mcg/mL), 50 mL Syringe, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-3 | Lack of assurance of sterility: | Terminated | null | 2023-09-21 | 2023-10-11 | Nationwide in the USA | 476, 50 mL Syringes | null | 3005292119 | 1 | 0 | Voluntary Action Indicated (VAI) | 2021-05-24 | 0 | 0 | null | false | 0 | sterility | sterility assurance failure |
Z-0419-2024 | device | Aizu Olympus Co., Ltd. | PCF-H190L, EVIS EXERA III COLONOVIDEOSCOPE | Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in loss of image, decreased suction, or impact the ability to effectively reprocess the device. This in turn may lead to unanticipated delay to... | Ongoing | null | 2023-10-16 | 2023-12-06 | null | 24 incorrectly repaired units | null | 3002964398 | 4 | 1 | Official Action Indicated (OAI) | 2022-07-08 | 1 | 1 | 2022-11-02 | true | 0 | device_malfunction | improperly repaired connector |
Z-0803-2014 | device | Civco Medical Instruments Inc | Civco Belly Board MRI, Reusable non-sterile glass fiber belly board with cushion, REF 126000, packaged 1 per box. Product Usage: This device is intended to reduce the irradiated small bowel volume of gynecological patients undergoing treatment in the pelvic region. | Scales adhered to the product may be misaligned from the zero reference such that one side will not match the other. | Terminated | null | 2013-10-25 | 2014-01-29 | null | 2 belly board | null | null | null | null | null | null | 0 | 0 | null | false | null | device_malfunction | misaligned scale |
D-0375-2023 | drug | Accord Healthcare, Inc. | BusPIRone Hydrochloride Tablets USP 7.5 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 16729-201-01 | CGMP Deviations: recalling drug products following an FDA inspection. | Terminated | null | 2023-02-07 | 2023-03-08 | United States including Puerto Rico and Canada | 23,784 bottles | 16729-200 | 3007518432 | 4 | 0 | No Action Indicated (NAI) | 2017-01-19 | 0 | 0 | null | false | 0 | cGMP | inspection deviations |
Z-2533-2015 | device | Covidien LLC | Mahurkar Elite Acute Triple Lumen Catheter Tray, Curved Extensions with IC* Safety Components, 12.5 Fr x 13 cm Item Code: 8888233413 Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access devices. | Sterility may be compromised | Terminated | null | 2015-08-06 | 2015-09-09 | null | 165 kits | null | 3011410703 | 3 | 0 | Voluntary Action Indicated (VAI) | 2016-03-11 | 0 | 0 | null | false | -1 | sterility | compromised sterility |
D-0554-2021 | drug | Cardinal Health Inc. | Chantix (varenicline) Tablets Continuing Month Box Contains: 4 Continuing Weeks (1 mg x 56 tablets) Rx only NDC 0069-0469-03 Distributed by Pfizer Labs Division of Pfizer Inc., NY, NY 10017 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Terminated | null | 2021-03-15 | 2021-06-02 | FL, GA, SC | 940 cartons | null | 3004008697 | 5 | 0 | No Action Indicated (NAI) | 2017-09-12 | 0 | 0 | null | false | 0 | cGMP | temperature excursion |
Z-1390-2025 | device | Covidien | Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula, REF: 7CN80R | Tracheostomy tube with cuff reusable inner cannula has a flange that may disconnect from the outer cannula of the device, which could cause respiratory failure, aspiration, unspecified tissue injury, aspiration, respiratory tract infection, bronchospasm, a delay to treatment and/or death. | Ongoing | null | 2025-02-26 | 2025-04-02 | null | 780 | null | 1317749 | 4 | 0 | No Action Indicated (NAI) | 2013-12-16 | 0 | 0 | null | false | 0 | device_malfunction | flange disconnection |
D-0506-2021 | drug | Cardinal Health Inc. | Pantoprazole Sodium Delayed-Release Tablets, USP 20 mg* 90 Tablets Rx Only NDC 62175-180-46 Distributed by: Kremers Urban Pharmaceuticals Inc. Princeton, NJ 08540, USA | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Terminated | null | 2021-03-15 | 2021-06-02 | FL, GA, SC | 4 bottles | 62175-617 | 3004008697 | 5 | 0 | No Action Indicated (NAI) | 2017-09-12 | 0 | 0 | null | false | 0 | cGMP | temperature excursion |
Z-0255-2024 | device | Stryker Corporation | Disposable Spetzler-Malis Bipolar forceps, 23CM SLM DISP BAYONET 0.5MM, Catalog Number 6780-230-005 | 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 | null | 3015967359 | 1 | 0 | Voluntary Action Indicated (VAI) | 2023-01-24 | 0 | 0 | null | false | 0 | mislabeling | incorrect expiration date |
Z-2083-2014 | device | DePuy Orthopaedics, Inc. | RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation. | The product can be difficult to remove from the Distal Stem both out of the package and after proximal reaming. | Terminated | null | 2014-06-03 | 2014-07-30 | null | 10,467 units | null | 1818910 | 8 | 1 | No Action Indicated (NAI) | 2024-03-28 | 2 | 2 | 2011-12-08 | false | -1 | device_malfunction | difficult removal |
D-0590-2019 | drug | King Bio Inc. | Dr. King's Natural Medicine Homeopathic Total Mold Allergy Relief, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806, UPC 357955519522, NDC 57955-6287-2 | Microbial contamination | Terminated | null | 2018-07-20 | 2019-03-20 | U.S.A. Nationwide, Canada, and Australia. | 1999 bottles | null | 1053442 | 8 | 1 | Voluntary Action Indicated (VAI) | 2023-07-28 | 2 | 2 | 2019-03-20 | false | -1 | contamination | microbial contamination |
Z-0373-2018 | device | Boston Scientific Corporation | PROPONENT SR 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 | 3001236349 | 8 | 0 | No Action Indicated (NAI) | 2019-09-25 | 0 | 0 | null | false | -1 | device_malfunction | sensor over-sensing |
D-1033-2017 | drug | SCA Pharmaceuticals | Potassium Chloride 40 meq Added to Sodium Chloride 0.9% 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 ---- NDC# 70004-0833-40 | Lack of Assurance of Sterility; product has the potential to leak. | Terminated | null | 2017-07-14 | 2017-08-02 | Nationwide | N/A | null | null | null | null | null | null | 0 | 0 | null | false | null | sterility | potential leak risk |
Z-2260-2015 | device | Medtronic MiniMed Inc. | MiniMed NGP 640G 1.8ml (mmol/L), Model No. MMT-1511; NGP 640G 1.8ml (mg/dL), Model No. 1512; NGP 640G PLGM 3ml (mmol/L), Model No. MMT-1711; NGP 640G PLGM 3ml (mg/dL), Model No. MMT-1712. | Medtronic MiniMed is recalling the MiniMed 620G and 640G insulin pumps because there are certain scenarios where the set Bolus screen will not timeout, which could cause confusion by showing a bolus amount that is no longer appropriate. | Terminated | null | 2015-06-19 | 2015-08-05 | null | 1936 units | null | null | null | null | null | null | 0 | 0 | null | false | null | software | screen timeout failure |
D-0973-2017 | drug | Baxter Healthcare Corporation | 0.9% Sodium Chloride Injection, USP, 100 mL VIAFLEX Container, Rx Only, Baxter Healthcare Corporation, Deerfield IL 60015 USA, Product Code: 2B1309, NDC: 0338-0049-38 | Lack of Assurance of Sterility: Bags have the potential to leak. | Terminated | null | 2017-07-06 | 2017-07-19 | Nationwide, Puerto Rico and Saudi Arabia | 295,200 bags | 0338-0043 | 2025695 | 3 | 1 | No Action Indicated (NAI) | 2017-03-03 | 1 | 1 | 2013-12-19 | false | 0 | sterility | bag leakage risk |
D-0884-2017 | drug | Dr. Reddy's Laboratories, Inc. | Zenatane (isotretinoin) Capsules, USP, 20 mg, 30-count (3 x 10 Prescription Packs) per carton, Rx Only, Manufactured By: Cipla Limited, Kurkumbh Village, Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupally 500 090 India, NDC 55111-136-81 | Failed Dissolution Specifications: out of specification results observed for low dissolution. | Terminated | null | 2017-05-22 | 2017-06-14 | Nationwide in the USA and Puerto Rico | 89,118 cartons | 55111-113 | 3011009040 | 1 | 0 | No Action Indicated (NAI) | 2025-08-21 | 0 | 0 | null | false | -1 | potency | low dissolution |
Z-0188-2017 | device | Windstone Medical Packaging, Inc. | Face Pack, Kit number AMS3641 convenience custom kits used for general surgery in hospital operating room | The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility. | Terminated | null | 2015-04-22 | 2016-10-26 | null | 27 kits | null | 1000125955 | 2 | 0 | No Action Indicated (NAI) | 2019-06-21 | 0 | 0 | null | false | -1 | sterility | defective gloves |
D-1394-2022 | drug | Family Dollar Stores, Llc. | VICKS VAPORUB 1.76 OZ SKU 919667 VICKS VAPOR RUB LAVENDER 1.76 OZ 999813 SWAN MEDICATED CHEST RUB 3.53 OZ SKU 920611 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. | CGMP Deviations: product held outside appropriate storage temperature conditions. | Ongoing | null | 2022-06-23 | 2022-08-31 | Nationwide within the United States | Unknown | null | null | null | null | null | null | 0 | 0 | null | false | null | cGMP | improper storage conditions |
Z-0186-2024 | device | CareFusion 303, Inc. | Alaris PCA Module 8120 | Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling contains syringes that have not been validated. | Ongoing | null | 2023-09-15 | 2023-11-15 | null | 86,393 units | null | 2016493 | 8 | 6 | Official Action Indicated (OAI) | 2024-05-22 | 1 | 1 | 2024-11-22 | false | -1 | device_malfunction | invalid syringe compatibility |
Z-0713-2025 | device | Trokamed GmbH | Sheath, 20 Fr., 130 mm (REF: WA2PS20S), gastroenterology-urology endoscopic access overtube. | If the inflow speed is too quick, it could result in reduced outflow through the shaft due to blood, tissue fragments and kidney stone fragments, and quickly build up of intrarenal pressure. | Ongoing | null | 2024-11-27 | 2025-01-22 | null | 34 units | null | 3004595684 | 2 | 1 | Voluntary Action Indicated (VAI) | 2016-02-19 | 1 | 1 | 2013-11-22 | false | 0 | device_malfunction | reduced outflow buildup |
Z-2385-2023 | device | Covidien LP | MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, Kit REF: 8888345603HP | Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, partially or fully, and/or uncured or excessive MDX may dislodge from the catheter lead to full catheter obstruction resul... | Ongoing | null | 2023-06-28 | 2023-08-23 | null | 2685 units | null | 1282497 | 8 | 0 | Voluntary Action Indicated (VAI) | 2022-11-18 | 0 | 0 | null | false | 0 | device_malfunction | catheter lumen occlusion |
Z-2332-2020 | device | Smith & Nephew, Inc. | smith&nephew R3 ZERO HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 42MM 71332242 46MM 71332246 48MM 71332248 50MM 71332250 52MM 71332252 54MM 71332254 56MM 71332256 58MM 71332258 60MM 71332260 62MM 71332262 64MM 71332264 Orthopedic implan... | A manufacturing error resulted in out of specification R3 Acetabular Shells | Ongoing | null | 2020-04-22 | 2020-06-17 | null | 1450 devices | null | 1219602 | 3 | 0 | No Action Indicated (NAI) | 2017-05-25 | 0 | 0 | null | false | 0 | cGMP | out of specification manufacturing |
D-1385-2012 | drug | Physicians Total Care, Inc | Morphine Sulfate Extended Release tablet, 30 mg, 60 tablet bottles, Rx only, Physician Total Care, Inc, Tulsa, Ok 74146-6234, NDC 54868-4033-00 | Labeling: Label mix-up; Bottles labeled to contain Morphine Sulfate IR may contain Morphine Sulfate ER and vice-versa. | Terminated | null | 2010-11-10 | 2012-06-27 | FL | 540 tablets (9 containers of 60 tablets each) | null | null | null | null | null | null | 0 | 0 | null | false | null | mislabeling | label mix-up |
Z-0058-2019 | device | Ortho Clinical Diagnostics Inc | VITROS Immunodiagnostic Products - Folate Reagent Pack(10758750009237) 1513266 | The recalling firm determined that biased results may occur for specific VITROS Immunodiagnostic Products (MicroWell Assays) at biotin concentrations which are lower than indicated in the current Instructions For Use (IFU). Patients who are taking biotin supplements could potentially have biased sample results for affe... | Ongoing | null | 2018-07-12 | 2018-10-10 | null | 7880 | null | null | null | null | null | null | 0 | 0 | null | false | null | software | assay performance bias |
Z-0776-2025 | device | Baxter Healthcare Corporation | Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product Code 35700BAX2 | Devices were identified as released after repair without full testing being performed, which includes flow testing. | Ongoing | null | 2024-11-19 | 2025-01-08 | null | 1 unit | null | 1019003 | 12 | 2 | No Action Indicated (NAI) | 2023-07-14 | 0 | 0 | null | false | 0 | device_malfunction | inadequate testing post-repair |
Z-1658-2024 | device | Boston Scientific Corporation | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL4.5 (5PK), REF H74908526232; 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 | 4715 catheters | null | 3005099803 | 7 | 0 | Voluntary Action Indicated (VAI) | 2024-11-26 | 0 | 0 | null | false | -1 | device_malfunction | polyurethane delamination |
D-0022-2020 | drug | Colonia Care Pharmacy | C-PAPAV/PHENTOL/PGE1 18MG/0.6MG/5.88MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067 | Lack of Assurance of Sterility: product sterility cannot be guaranteed. | Terminated | null | 2019-07-24 | 2019-10-09 | Patient Specific Prescriptions in NJ | 1 vial | null | 3012223534 | 3 | 3 | Official Action Indicated (OAI) | 2021-07-26 | 1 | 1 | 2017-10-12 | false | -1 | sterility | sterility assurance failure |
D-0020-2020 | drug | Colonia Care Pharmacy | C-PAPAV/PHENTOL/PGE1 10MG/1MG/20MCG/ML, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067 | Lack of Assurance of Sterility: product sterility cannot be guaranteed. | Terminated | null | 2019-07-24 | 2019-10-09 | Patient Specific Prescriptions in NJ | 1 vial | null | 3012223534 | 3 | 3 | Official Action Indicated (OAI) | 2021-07-26 | 1 | 1 | 2017-10-12 | false | -1 | sterility | sterility assurance failure |
D-0250-2022 | drug | Bayer Healthcare Pharmaceuticals Inc. | Tinactin (Tolnaftate 1%) DEODORANT POWDER SPRAY NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, UPC 3 11017 41000 4, NDC 11523-4162-1, Product of Finland 20006105 | Chemical Contamination: presence of benzene | Terminated | null | 2021-10-01 | 2021-11-24 | Distributed Nationwide in the US, Puerto Rico, Canada and Mexico through a variety of retail channels. | 738,432 cans | 11523-4162 | 2243252 | 9 | 0 | No Action Indicated (NAI) | 2025-08-15 | 0 | 0 | null | false | -1 | contamination | benzene presence |
Z-2702-2017 | device | Penumbra Inc. | Penumbra 3D Revascularization Device It is indicated for used in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral-M1 and M2 segments) within 8 hours of symptom onset. Patients who are ineligible for intra... | Penumbra has identified an issue in these four lots involving a raw material component of the delivery wire. This issue could result in breakage of the delivery wire, which could potentially lead to serious patient injury or death. | Terminated | null | 2017-06-09 | 2017-07-26 | null | 155 units | null | 3005168196 | 10 | 1 | No Action Indicated (NAI) | 2021-06-21 | 1 | 1 | 2009-12-31 | false | -1 | device_malfunction | delivery wire breakage |
D-1493-2022 | drug | Plastikon Healthcare LLC | CORRECTDOSE Children's PAIN RELIEF & Fever Reducer, Cherry, (Acetaminophen 160 mg per 5 mL), 2.04 FL.OZ (60mL), packaged in 12-5mL individual doses, Distributed by Correct Dose Inc, Braintree MA 02184. NDC 62320-311-05 UPC 8 60003 67145 0 | CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled. | Terminated | null | 2022-06-07 | 2022-09-14 | Distributed Nationwide in the USA | 1,464 ampoules | null | 3009840089 | 5 | 1 | No Action Indicated (NAI) | 2024-04-30 | 1 | 1 | 2022-04-20 | false | -1 | cGMP | inadequate process control |
D-0753-2019 | drug | King Bio Inc. | Dr. King's SafeCare Rx Adrenal Burnout Mind & Body, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955097921, NDC 57955-0981-2 | Microbial contamination | Terminated | null | 2018-07-20 | 2019-03-20 | U.S.A. Nationwide, Canada, and Australia. | 1491 bottles | null | 1053442 | 8 | 1 | Voluntary Action Indicated (VAI) | 2023-07-28 | 2 | 2 | 2019-03-20 | false | -1 | contamination | microbial contamination |
D-0681-2023 | drug | Central Admixture Pharmacy Services, Inc. | Modified del Nido Microplegia, packaged in 40 mL per syringe, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0219-1. | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. | Terminated | null | 2023-04-28 | 2023-05-31 | Nationwide in the USA. | 690 syringes | null | 3009590582 | 4 | 3 | Official Action Indicated (OAI) | 2023-03-30 | 3 | 3 | 2024-03-29 | true | 0 | sterility | sterility assurance |
Z-0244-2024 | device | Stryker Corporation | Disposable Spetzler-Malis Bipolar forceps, 23CM SM DISP BAYONET 1.5MM TIP, Catalog Number 6760-230-015 | 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 | 3015967359 | 1 | 0 | Voluntary Action Indicated (VAI) | 2023-01-24 | 0 | 0 | null | false | 0 | mislabeling | incorrect expiration date |
Z-1565-2025 | device | Baxter Healthcare Corporation | Welch Allyn Spot Vital Signs 4400 Device, Product Code/Part Numbers: 1) 44WT-2; 2) 44WT-3; 3) 44WT-4; 4) 44WT-6; 5) 44WT-B; 6) 44XT-2; 7) 44XT-4; 8) 44XT-6; 9) 44XT-B. | Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs. | Ongoing | null | 2025-03-21 | 2025-04-23 | null | 34187 units | null | 3006472186 | 4 | 0 | Voluntary Action Indicated (VAI) | 2016-11-29 | 0 | 0 | null | false | 0 | undeclared_allergen | natural rubber latex |
D-1198-2015 | drug | Lincare, Inc. | Potassium Chloride, Dextrose 5% LR 1000 mL with 40mEq KCL, Qty: 1 1000 mL Bag, 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 | 1 Bag | null | 1000116354 | 1 | 0 | No Action Indicated (NAI) | 2010-03-02 | 0 | 0 | null | false | 0 | sterility | sterility not assured |
Z-0600-2023 | device | DeRoyal Industries Inc | DeRoyal BASIC NEURO PACK, REF 89-7523.16 | XXX | Ongoing | null | 2022-11-03 | 2022-12-21 | null | 304 kits | null | 3006369524 | 4 | 0 | Voluntary Action Indicated (VAI) | 2019-10-01 | 0 | 0 | null | false | 0 | other | insufficient information |
D-1151-2022 | drug | Vi-Jon, LLC | 70% ISOPROPYL ALCOHOL First aid antiseptic, 4 FL OZ (118 mL) bottle, Made in US with US and foreign components for Medline Industries, Inc., Mundelein, IL 60060 USA, NDC: 53329-798-04, UPC (01) 10888277362291. | Defective Container: Product may leak when squeezed or when not in an upright position determined to be due to defects in the bottle neck finish and insufficient tightening. | Terminated | null | 2022-06-15 | 2022-06-29 | Nationwide in the USA | 3,157,620 bottles | 53329-798 | null | null | null | null | null | 0 | 0 | null | false | null | packaging | defective container closure |
Z-1322-2020 | device | Nobel Biocare Usa Llc | Abutment Screw Retrieval Instrument 3.0/NP - Product Usage: The instruments for abutment screw retrieval can be used if an abutment screw is broken and a part of the screw is left inside the implant screw channel. If the implant thread needs to be cleaned before placing a new screw, a screw tap repair can be used. The ... | Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life. | Terminated | null | 2019-03-14 | 2020-02-26 | null | 233 units | null | 1000125598 | 7 | 0 | No Action Indicated (NAI) | 2025-08-08 | 0 | 0 | null | false | -1 | sterility | packaging seal failure |
Z-0954-2015 | device | GE Healthcare | GE Healthcare, Proteus XR/a with wall stand model number 600-0301. | GE Healthcare has recently become aware of a potential safety issue involving the breakage of the two steel cables which support the bucky device in the wall stand of Proteus XR/a X-ray imaging systems. No injuries reported. | Terminated | null | 2014-12-08 | 2015-01-21 | null | 3096 (2486 US, 610 OUS). | null | 3004526608 | 3 | 0 | No Action Indicated (NAI) | 2014-08-20 | 0 | 0 | null | false | 0 | device_malfunction | cable breakage |
D-0447-2021 | drug | Cardinal Health Inc. | DEXAMETH SOD PHOS 0.1% 5ML; NDC/UPC 24208072002; RX; DROPS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Terminated | null | 2021-03-15 | 2021-06-02 | FL, GA, SC | 318 droptainers | null | 3003474118 | 3 | 0 | No Action Indicated (NAI) | 2025-02-19 | 0 | 0 | null | false | -1 | cGMP | temperature excursion |
Z-2089-2020 | device | Howmedica Osteonics Corp. | Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 58 Right, Sterile, Catalog # 504-02-58D-R, UDI (01)07613327012446(17) | The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating debris. | Terminated | null | 2020-04-16 | 2020-05-27 | null | 4895 | null | 3003070421 | 7 | 0 | Voluntary Action Indicated (VAI) | 2023-12-01 | 0 | 0 | null | false | -1 | device_malfunction | component detachment |
D-0420-2018 | drug | Dr. Reddy's Laboratories, Inc. | Atorvastatin Calcium Tablets 40 mg, 90 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd., Srikakulam, INDIA --- NDC 55111-123-05 | Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability | Terminated | null | 2018-01-29 | 2018-02-07 | Nationwide | 12,579 bottles | 55111-121 | 3003989912 | 4 | 0 | Voluntary Action Indicated (VAI) | 2022-05-26 | 0 | 0 | null | false | -1 | stability | degradation impurities |
Z-2644-2023 | device | B. Braun Medical, Inc. | B.Braun NORM-JECT Luer Lock Solo, 10 ml, Sterile-Intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to/from the body. Distributed by: Air-Tite Products Co., Inc, 565 Central Drive, Virginia Beach, VA 23454. REF: NJ-4606728-02 | The sterile blister packaging may be damaged, and sterility may be compromised | Ongoing | null | 2023-08-07 | 2023-10-04 | null | 604,800 units | null | 3014301563 | 1 | 0 | Voluntary Action Indicated (VAI) | 2018-12-27 | 0 | 0 | null | false | 0 | sterility | damaged blister packaging |
Z-0562-2025 | device | Baxter Healthcare Corporation | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4483; use in Peritoneal Dialysis | There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set. | Ongoing | null | 2024-10-23 | 2024-12-04 | null | 62,718 | null | 2650090 | 9 | 1 | Voluntary Action Indicated (VAI) | 2025-03-26 | 1 | 1 | 2011-01-20 | false | -1 | device_malfunction | connector separation |
D-1078-2016 | drug | Reliable Rexall-A Compounding Pharmacy | All fluocinonide 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 | inadequate processing controls |
D-1457-2016 | drug | Actavis Inc | Glipizide 2.5 mg Extended-release tablets, 30-count bottle, Rx Only, Manufactured By: Patheon Pharmaceuticals Inc Cincinnati, OH 45237, NDC 00591-0900-30 | Failed Dissolution Specifications: Glipizide 2.5 mg ER Tablets exceeded dissolution specification rates for the 10 hour testing point. | Terminated | null | 2016-06-30 | 2016-08-24 | Nationwide | 167,152 bottles | null | null | null | null | null | null | 0 | 0 | null | false | null | potency | failed dissolution |
D-0946-2019 | drug | King Bio Inc. | NET Remedies #7 Flora Plus Homeopathic Preparation, Oral Liquid, 57 mL, NDC 57955-4207-2 | Microbial contamination | Terminated | null | 2018-07-20 | 2019-03-20 | U.S.A. Nationwide, Canada, and Australia. | 9888 bottles | null | 1053442 | 8 | 1 | Voluntary Action Indicated (VAI) | 2023-07-28 | 2 | 2 | 2019-03-20 | false | -1 | contamination | microbial contamination |
Z-1305-2014 | device | Medtronic Vascular, Inc. | FIBERNET Embolic Protection System: Recommended Vessel Diameter 6.0 -7.0 mm, Maximum Guidewire Diameter: 0.014 in (0.36mm) Rx only, Sterile; Manufactured in: Invatec S.P.A., Italy; Manufacturer: Medtronic Inc. Minneapolis, MN. The FiberNet Embolic Protection System is indicated for use as a guidewire and emb... | Medtronic is recalling a specific subset of lot numbers of the FIBERNET Embolic Protection System (EPS) where the yellow polyimide tube on the FIBERNET EPS was not removed from the FIBERNET EPS during the manufacturing process and subsequently may remain on the FIBERNET EPS. | Terminated | null | 2014-03-03 | 2014-04-02 | null | 50 Total all sizes: 18 in US, 32 Internationally | null | 3008493192 | 2 | 0 | No Action Indicated (NAI) | 2017-04-19 | 0 | 0 | null | false | -1 | device_malfunction | manufacturing defect component |
Z-0190-2026 | device | Baxter Healthcare Corporation | CLEARLINK System Solution Set, DUO-VENT, CLEARLINK Luer Activated Valve, 10 drops/mL, 92-inch (2.3 meters), Product code 2C8419 | IV sets may leak. | Ongoing | null | 2025-08-29 | 2025-10-22 | null | 136512 | null | 1025114 | 11 | 5 | Official Action Indicated (OAI) | 2024-02-09 | 0 | 0 | null | true | 0 | device_malfunction | leaking IV sets |
D-0286-2018 | drug | Medline Industries Inc | Medline Staple Remover Kit, Sterile, Single Use Only. Packaged in USA 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 | 600 cases | null | 3019239304 | 1 | 0 | No Action Indicated (NAI) | 2024-11-04 | 0 | 0 | null | false | -1 | potency | subpotent iodine |
Z-2498-2016 | device | Biomet 3i, LLC | Certain Temporary Hexed Cylinder Dental implants | Pouches may not have been sealed during packing. | Terminated | null | 2015-11-25 | 2016-08-24 | null | 1,648,273 devices (all products subject to this recall) | null | null | null | null | null | null | 0 | 0 | null | false | null | packaging | unsealed pouches |
Z-2401-2016 | device | Invacare Corporation | Invacare¿ Foot Section for Semi & Full Electric Beds, Junction Boxes, Product Usage: The Invacare Bariatric home care bed is intended to provide a rest surface with adjustable height from floor and adjustable surface contours. | The firm recently identified a quality issue with the Junction box used in the Invacare Bariatric Bed. They discovered that the Junction Box may omit sparks which could result in a fire in the presence of flammable materials. | Terminated | null | 2016-03-15 | 2016-08-17 | null | 3,050 units | null | 1031452 | 5 | 2 | No Action Indicated (NAI) | 2017-11-27 | 1 | 1 | 2010-12-15 | false | -1 | device_malfunction | fire hazard defect |
Z-0786-2013 | device | Philips Medical Systems (Cleveland) Inc | Mx8000 IDT Whole Body Computed Tomography X-ray system Distributed by Philips Medical Systems, Highland Heights, OH 44143 The Brilliance Scanner are computed Tomography X-ray systems with multi-slice capability of up to 16 slices,which are intended to produce cross-sectional images of the body by computer reconstruc... | The low contrast pins in the Image Quality (IQ) phantom deteriorates over time. This prevents the customers from doing the Daily Image Quality Checks as defined in the current Instructions for Use (IfU). | Terminated | null | 2012-09-18 | 2013-03-06 | null | 1,474 Units | null | 1525965 | 10 | 2 | No Action Indicated (NAI) | 2019-11-26 | 1 | 1 | 2011-06-07 | false | -1 | device_malfunction | phantom pin degradation |
Z-0931-2026 | device | Datascope Corp. | Cardiosave Hybrid | The IFU addendum updates the Vibration and Shock Table to reference the correct standards. | Ongoing | null | 2025-10-23 | 2025-12-24 | null | 11470 units (5095 US, 6375 OUS) | null | 1000222374 | 2 | 1 | Official Action Indicated (OAI) | 2018-06-11 | 1 | 1 | 2018-09-11 | true | 0 | software | IFU documentation error |
Z-0650-2016 | device | Biomet, Inc. | Biomet Integral Centralizer Hip System, Lateralized Femoral Stem (Co-Cr-Mo), 9mm, 11mm, 13mm, 15mm, and 17mm | PMMA is listed as a material on the label but the product does not contain PMMA. | Terminated | null | 2015-11-17 | 2016-01-20 | null | 21 | null | 1825034 | 7 | 0 | Voluntary Action Indicated (VAI) | 2023-11-09 | 2 | 2 | 2018-08-24 | false | -1 | mislabeling | incorrect material listing |
D-0564-2021 | drug | Cardinal Health Inc. | Cefazolin for Injection, USP 1 gram per vial Rx Only Single-use Vial Sterile Manufactured in Austria by Sandoz GmbH for Sandoz, Inc., Princeton, NJ 08540, NDC 0781-3451-70 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Terminated | null | 2021-03-15 | 2021-06-02 | FL, GA, SC | 8 vials | 0781-3450 | 1000148701 | 3 | 0 | No Action Indicated (NAI) | 2020-02-19 | 0 | 0 | null | false | 0 | cGMP | temperature excursion |
Z-2194-2020 | device | Baxter Healthcare Corporation | Gambro Cartridge Blood Transport System for Hemodialysis Blood Set - Product Usage: is intended for single use in a hemodialysis treatment using Dialysis Delivery Systems. | Potential disconnection of tubing set. | Terminated | null | 2020-04-17 | 2020-06-10 | null | 53,895 units | null | 3007319130 | 4 | 0 | No Action Indicated (NAI) | 2016-01-07 | 0 | 0 | null | false | 0 | device_malfunction | tubing disconnection |
Z-1128-2025 | device | Cardinal Health 200, LLC | Cardinal Health Presource Kits: 1) UROLOGY ROBOTIC PACK, Catalog Number:SOT4FRUWFA; 2) UROLOGY ROBOTIC PACK, Catalog Number:SOT4FRUWFB; 3) UROLOGY ROBOTIC PACK, Catalog Number:SOT4FRUWFC | Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. | Ongoing | null | 2024-11-08 | 2025-02-19 | null | 973,785 total units | null | 2016452 | 3 | 0 | No Action Indicated (NAI) | 2021-12-21 | 0 | 0 | null | false | 0 | contamination | endotoxin contamination |
Z-2711-2014 | device | Philips Medical Systems (Cleveland) Inc | The Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scanners are Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient... | Ingenuity CT system can mislabel the exposure that results in an image in the incorrect order that it was taken by the user. | Terminated | null | 2014-09-11 | 2014-10-08 | null | 79 | null | 1525965 | 10 | 2 | No Action Indicated (NAI) | 2019-11-26 | 1 | 1 | 2011-06-07 | false | -1 | software | image sequencing error |
Z-0293-2024 | device | Philips North America Llc | Brilliance CT Big Bore with software version V4.8.0.10421 Model:728244 CT scanner and simulator designed for radiation oncology and therapy. | For oncology users: If the user performed off-set reconstruction on CT device a shift could be observed on the contouring area of the primary and secondary images sets when using image fusion (on TPS) and incorrect coordinates may be sent to TPS system when using absolute patient marking. This may lead to incorrect rad... | Ongoing | null | 2023-10-09 | 2023-11-22 | null | 11 units | null | 1000524572 | 10 | 2 | Voluntary Action Indicated (VAI) | 2022-10-27 | 2 | 1 | 2017-10-31 | false | 0 | software | reconstruction algorithm error |
Z-2637-2014 | device | Data Innovations, LLC | ProVue Instrument Driver for JResultNet (ProVue.jrm) v. 1.5.3 and below JResultNet is a stand-alone software package that provides connectivity between in-vitro diagnostic instruments (IVDs) and Laboratory Information Systems (LIS) aiding the flow of laboratory information, including test orders and results, specime... | Potential issues with the ProVue driver have been identified which may cause data to be misassociated with patient results under a given set of circumstances. | Terminated | null | 2014-08-15 | 2014-09-24 | null | 84 | null | 3001451449 | 1 | 0 | Voluntary Action Indicated (VAI) | 2016-09-01 | 0 | 0 | null | false | -1 | software | data misassociation |
Z-1841-2022 | device | Cook Incorporated | Roadrunner PC Wire Guide (The Firm), Guidewire Reference Part Number/GPN RPC-35-145 G06979 RPC-35-80 G09534 | Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised. | Ongoing | null | 2022-08-16 | 2022-10-05 | null | 363 US; 244 OUS | null | 1825146 | 3 | 0 | No Action Indicated (NAI) | 2017-05-26 | 0 | 0 | null | false | 0 | sterility | compromised packaging seal |
Z-2570-2016 | device | Medtronic | Valleylab Laparoscopic Curved Spatula Electrode Retractable 28CM Item Code: E2781R28ASP The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable | Potential for compromise of the package resulting in a breach of the sterile barrier | Terminated | null | 2016-07-08 | 2016-08-24 | null | N/A | null | 3004097636 | 4 | 0 | No Action Indicated (NAI) | 2016-02-01 | 0 | 0 | null | false | 0 | sterility | sterile barrier compromise |
Z-1696-2014 | device | Davol, Inc., Subs. C. R. Bard, Inc. | Bard¿ Ventralight" ST Mesh with Echo PS" 8"x10" Reorder Number: 5955810 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias. | Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal. | Terminated | null | 2014-04-24 | 2014-06-11 | null | null | null | null | null | null | null | 0 | 0 | null | false | null | sterility | compromised pouch seal | |
Z-3060-2017 | device | Shippert Medical Technologies | Tissu-Trans Filtron 100, 3-TT-FILTRON 100. Product Usage: Intended for fat transfer and liposuction. | Seal integrity of the Tissu-Trans product sterile packages cannot be assured. | Terminated | null | 2017-06-01 | 2017-08-30 | null | 5,188 units total | null | null | null | null | null | null | 0 | 0 | null | false | null | sterility | compromised package seal |
D-1365-2015 | drug | Reckitt Benckiser LLC | Mucinex Fast-Max Cold & Sinus, Maximum Strength, Acetaminophen Pain Reliever/Fever Reducer, Guaifenesin Expectorant, Phenylephrine HCl Nasal Decongestant, 6 fl oz (180 mL) Bottle, For Ages 12+, Dist. by: Reckitt Benckiser Parsippany, NJ 07054-0224 Made in India, NDC 63824-016-66, UPC 63824-01665-8 | Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. As a result cert... | Terminated | null | 2015-04-15 | 2015-09-02 | Nationwide | 379,284 Bottles | null | 3011867128 | 3 | 0 | No Action Indicated (NAI) | 2026-01-20 | 0 | 0 | null | false | -1 | mislabeling | missing active ingredients |
Z-1191-2026 | device | Medline Industries, LP | Medline medical procedure convenience kits labeled as: 1) SMJ LAP CHOLE PACK-LF, Kit SKU DYNJ19974P; 2) DEPAUL ABDOMINAL ENDOSCOPY-LF, Kit SKU DYNJ20027K; 3) LAPAROSCOPY PACK-LF, Kit SKU DYNJ20468J; 4) SMJ LAPAROSCOPY PACK, Kit SKU DYNJ25763N; 5) SMJ LAPAROSCOPY PACK, Kit SKU DYNJ25763O; 6) BWNBORO LAP CHO... | Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive. | Ongoing | null | 2025-12-12 | 2026-02-04 | null | 456 units | null | 3024832985 | 1 | 0 | No Action Indicated (NAI) | 2025-07-21 | 0 | 0 | null | false | 0 | device_malfunction | tubing cracking defect |
D-1355-2022 | drug | Aire-Master of America Inc | Avant Foaming Hand Sanitizer, ethanol 62%, a) 18 fl. oz. bottle (530 mL), b) 1000 mL (33.9 fl. oz.) pouch, c) 55 gallon drum, Fragrance Free, Manufactured for B4 Brands, Lisbon, Iowa 62253 | CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization. | Terminated | null | 2022-07-15 | 2022-08-24 | Florida, Illinois, Iowa, New Jersey | 18 oz bottle: 11,435 bottles; 1000 mL pouch: 4,116 pouches, c) 2 drums | null | 3002764676 | 3 | 1 | Official Action Indicated (OAI) | 2021-10-19 | 1 | 1 | 2022-05-23 | true | 0 | cGMP | water system control |
Z-1827-2024 | device | Philips North America Llc | Patient Information Center iX and Patient Information Center iX Expand, Software Version 4.x. | Event Catalog information does not save when copied and transferred from one unit to another. | Ongoing | null | 2024-04-19 | 2024-05-22 | null | 358 units (US: 45; OUS: 313) | null | 1000524572 | 10 | 2 | Voluntary Action Indicated (VAI) | 2022-10-27 | 2 | 1 | 2017-10-31 | false | 0 | software | data persistence issue |
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