Browse Device Recalls

3,276 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,276 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 3,276 FDA device recalls in 2024.

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DateProductReasonClassFirm
Jan 9, 2024 Custodiol HTK Solution, 500ml bottle. 10 per carton. Potential for particles to be present in solution. Class II Dr Franz Koehler Chemie Gmbh
Jan 9, 2024 Medtronic Invos, Reusable Sensor Cable for PM7100, REF: PMAC71RSC manufacturing defects to sensor cable connectors may result in error codes or non-functioning c... Class II Covidien
Jan 9, 2024 Signature Laparoscopic Instruments, Sharp Tooth Grasper with Rotating Shaft a... Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, l... Class II Silex Medical, LLC
Jan 9, 2024 DISP.TROCAR W.DILATING PIN 12/110MM, Product Code EK236SU. For use in laparos... The sterile blister packaging may be damaged, and sterility may be compromised. Class II Aesculap Inc
Jan 9, 2024 Signature Laparoscopic Instruments, Debakey Grasper with Rotating Shaft and M... Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, l... Class II Silex Medical, LLC
Jan 9, 2024 DISP.TROCAR W.DILATING PIN 12/110MM, Product Code EK234SU. For use in laparos... The sterile blister packaging may be damaged, and sterility may be compromised. Class II Aesculap Inc
Jan 9, 2024 Sekisui Diagnostics Control Kit OSOM¿ BVBLUE¿ Bacterial Vaginosis Facility Critical Temperature Excursions on 08-JAN 2024 in Walk-In refrigerator due to mechanical... Class II Mckesson Medical-Surgical Inc. Corporate Office
Jan 9, 2024 Signature Laparoscopic Instruments, Bullet Tip Grasper with Rotating Shaft an... Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, l... Class II Silex Medical, LLC
Jan 9, 2024 DISP.HASSON TROCAR 10/110MM, Product Code EK230SU. For use in laparoscopic pr... The sterile blister packaging may be damaged, and sterility may be compromised. Class II Aesculap Inc
Jan 9, 2024 Steris Corporation Endo Cleaning Indicator VERIFY" RESITEST" Facility Critical Temperature Excursions on 08-JAN 2024 in Walk-In refrigerator due to mechanical... Class II Mckesson Medical-Surgical Inc. Corporate Office
Jan 9, 2024 Medtronic Invos, Reusable Infant Sensor Adapter Cable for PM7100, REF: PMAC71RIC manufacturing defects to sensor cable connectors may result in error codes or non-functioning c... Class II Covidien
Jan 8, 2024 BD BBL Sensi Disc Clarithromycin- 15 ug, used for semi-quantitative in vitro ... There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibil... Class II Becton Dickinson & Co.
Jan 8, 2024 BD BBL Sensi Disc Ampicillin with Sulbactam 10/10 ¿g, Catalog Number 231660... There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibil... Class II Becton Dickinson & Co.
Jan 8, 2024 BD BBL Sensi Disc Doripenem- 15 ug, used for semi-quantitative in vitro susce... There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibil... Class II Becton Dickinson & Co.
Jan 8, 2024 BEQ-RF-32-USA RotaFlow Centrifugal Pump with BIOLINE Coating, Product Code 70... Nonconformities at their seal could potentially compromise the sterile barrier for affected produ... Class II Maquet Medical Systems USA
Jan 8, 2024 BD BBL Sensi Disc Ceftriaxone- 30 ug, used for semi-quantitative in vitro sus... There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibil... Class II Becton Dickinson & Co.
Jan 8, 2024 BD BBL Sensi Disc Cefuroxime- 30 ug, used for semi-quantitative in vitro susc... There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibil... Class II Becton Dickinson & Co.
Jan 8, 2024 BD BBL Sensi Disc Ampicillin - 10 ¿g, Catalog No. 230705 and 231264; 2 ¿g, Ca... There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibil... Class II Becton Dickinson & Co.
Jan 8, 2024 BO-RF-32-USA RotaFlow Centrifugal Pump with SOFTLINE Coating, Product Code 70... Nonconformities at their seal could potentially compromise the sterile barrier for affected produ... Class II Maquet Medical Systems USA
Jan 8, 2024 BD BBL Sensi Disc Cefixime - 5 ug¿, used for semi-quantitative in vitro susce... There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibil... Class II Becton Dickinson & Co.
Jan 8, 2024 Microbiologics Enteric Pathogens Control Panel (Inactivated Pellet), REF 8184. The negative control was contaminated with one of the positive control pathogens (Norovirus). Th... Class II Microbiologics Inc
Jan 8, 2024 BD BBL Sensi Disc Ofloxacin- 5 ug, used for semi-quantitative in vitro suscep... There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibil... Class II Becton Dickinson & Co.
Jan 8, 2024 BD BBL Sensi Disc Ceftazidime- 30 ug, used for semi-quantitative in vitro sus... There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibil... Class II Becton Dickinson & Co.
Jan 8, 2024 BD BBL Sensi Disc Sulfamethoxazole with Trimethoprim 23.75/1.25 ug, used for ... There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibil... Class II Becton Dickinson & Co.
Jan 8, 2024 BD BBL Sensi Disc Augmentin - 3¿g, Catalog Number 291270¿used for semi-quanti... There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibil... Class II Becton Dickinson & Co.
Jan 8, 2024 BD BBL Sensi Disc Levofloxacin- 5 ug, used for semi-quantitative in vitro sus... There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibil... Class II Becton Dickinson & Co.
Jan 8, 2024 BD BBL Sensi Disc Aztreonam - 30 ug¿, used for semi-quantitative in vitro su... There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibil... Class II Becton Dickinson & Co.
Jan 8, 2024 BD BBL Sensi Disc Ciprofloxacin- 5 ug, used for semi-quantitative in vitro su... There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibil... Class II Becton Dickinson & Co.
Jan 8, 2024 BD BBL Sensi Disc Ertapenem- 10 ug, used for semi-quantitative in vitro susce... There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibil... Class II Becton Dickinson & Co.
Jan 8, 2024 BD BBL Sensi Disc Chloramphenicol- 30 ug, used for semi-quantitative in vitro... There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibil... Class II Becton Dickinson & Co.
Jan 8, 2024 BD BBL Sensi Disc Moxifloxacin- 5 ug, used for semi-quantitative in vitro sus... There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibil... Class II Becton Dickinson & Co.
Jan 8, 2024 BD BBL Sensi Disc Imipenem- 10 ug, used for semi-quantitative in vitro suscep... There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibil... Class II Becton Dickinson & Co.
Jan 8, 2024 BD BBL Sensi Disc Cefepime - 30 ug¿, used for semi-quantitative in vitro sus... There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibil... Class II Becton Dickinson & Co.
Jan 8, 2024 BD BBL Sensi Disc Ceftaroline - 30 ug, used for semi-quantitative in vitro su... There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibil... Class II Becton Dickinson & Co.
Jan 8, 2024 BD BBL Sensi Disc Meropenem- 10 ug, used for semi-quantitative in vitro susce... There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibil... Class II Becton Dickinson & Co.
Jan 8, 2024 BD BBL Sensi Disc Tetracycline 30 ug,used for semi-quantitative in vitro susc... There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibil... Class II Becton Dickinson & Co.
Jan 8, 2024 BD BBL Sensi Disc Cefotaxime - 30 ug¿, used for semi-quantitative in vitro su... There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibil... Class II Becton Dickinson & Co.
Jan 8, 2024 BD BBL Sensi Disc Cefaclor - 30 ug¿, used for semi-quantitative in vitro susc... There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibil... Class II Becton Dickinson & Co.
Jan 8, 2024 BD BBL Sensi Disc Minocycline - 30 ug, used for semi-quantitative in vitro s... There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibil... Class II Becton Dickinson & Co.
Jan 8, 2024 Sensi Disc Amoxicillin with Clavulanic Acid 20/10 ¿g, Catalog No. 231628 an... There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibil... Class II Becton Dickinson & Co.
Jan 8, 2024 BD BBL Sensi Disc Cefpodoxime - 10 ug, used for semi-quantitative in vitro su... There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibil... Class II Becton Dickinson & Co.
Jan 8, 2024 BD BBL Sensi Disc Rifampin- 5 ug, used for semi-quantitative in vitro suscept... There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibil... Class II Becton Dickinson & Co.
Jan 8, 2024 BD BBL Sensi Disc Azithromycin -15 ¿g, Catalog Number 231682¿used for semi-qu... There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibil... Class II Becton Dickinson & Co.
Jan 8, 2024 BD BBL Sensi Disc Piperacillin/Tazobactam- 100/10 ug, used for semi-quantita... There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibil... Class II Becton Dickinson & Co.
Jan 5, 2024 Hemostasis Probe, Model: CD-B622LA The BICOAG Hemostasis Probe with a coaxial plug was mispackaged into the package and labeled as a... Class II Olympus Corporation of the Americas
Jan 5, 2024 OPTIMIZER model CCM X11 implantable pulse generator (IPG) devices - Smart Min... OPTIMIZER devices may cease to deliver CCM therapy if the device incorrectly detects a charging e... Class II IMPULSE DYNAMICS (USA) INC
Jan 4, 2024 Medline Contro-Bulb Syringe, REF DYND20125; bulb irrigation syringe Packaging material was updated for the Bulb Irrigation Syringe (DYND20125), and additional testin... Class II MEDLINE INDUSTRIES, LP - Northfield
Jan 3, 2024 SmartPath to dStream for 1.5T. Model (REF) Numbers 781260, 782112. The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in cont... Class II Philips North America
Jan 3, 2024 USTAR II Knee System Cemented curved stem, RHS, Non Coated for the following ... Their is a potential that the implant curved stem may be oriented incorrectly. Class II United Orthopedic Corporation
Jan 3, 2024 The Prestige Coil System is a product family of embolic coils with associated... Discoloration was identified along the delivery pusher which was attributed to corrosion of the h... Class II BALT USA, LLC

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.