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Vehicle Recalls320,000+ NHTSA safety recalls Browse VehiclesEvery make, model and year Complaints2.1M+ consumer safety complaints TSBs4.7M technical service bulletins VIN LookupDecode any vehicle VIN instantly OBD Codes12,000+ diagnostic trouble codes Fuel EconomyEPA MPG data for all vehicles Safety Ratings11,700+ NHTSA crash test ratings Investigations5,300+ NHTSA defect investigations StatisticsRecall trends & safety analysis Compare VehiclesTwo vehicles side by side

Consumer Safety

Product Safety9,700+ CPSC product recalls Food Safety28,600+ FDA food recalls Pet Safety1.3M FDA animal adverse events Drug Safety17,500+ FDA drug recalls Device Safety38,400+ FDA device recalls Workplace Safety102,900+ OSHA injury reports Brand HistoryRecall lookup by company

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Browse Device Recalls

2,609 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,609 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 2,609 FDA device recalls in 2023.

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DateProductReasonClassFirm
Jun 6, 2023 Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, ... There is the potential for out of specification device geometries. widths, lengths, heights, and... Class II Medtronic Sofamor Danek USA Inc
Jun 6, 2023 Vios Monitoring System Bedside Monitor, Model BSM2050, Software Version Numbe... A premature failure condition was identified with the L2050R pulse oximeter SpO2 sensor that conn... Class II Murata Vios, Inc.
Jun 6, 2023 Vanta with AdaptiveStim Implantable Neurostimulator, Model 977006; spinal cho... A cardioversion procedure may damage the electronics in the Vanta INS device, making the INS unre... Class II Medtronic Neuromodulation
Jun 6, 2023 OmniTom/OmniTom Elite- X-ray computed tomography applications for anatomy tha... 1. Wheels loosening over time with use of the device could lead to the inability to effectively d... Class II NeuroLogica Corporation
Jun 6, 2023 GE Healthcare Giraffe Incubator Carestation CS1, Infant Incubator. Model Numb... Prior to current established manufacturing practices, higher levels of airborne formaldehyde expo... Class I DATEX--OHMEDA, INC.
Jun 6, 2023 Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, ... There is the potential for out of specification device geometries. widths, lengths, heights, and... Class II Medtronic Sofamor Danek USA Inc
Jun 6, 2023 Medtronic Catalyft LS Expandable Interbody System Implant Kit, Anterior Stand... There is the potential for out of specification device geometries. widths, lengths, heights, and... Class II Medtronic Sofamor Danek USA Inc
Jun 5, 2023 Exactech Shoulder GPS Impactor Handle, Catalog #531-07-05. The ball and spring housed within the locking mechanism of the handle can dislodge during disasse... Class II Exactech, Inc.
Jun 5, 2023 VITROS Immunodiagnostic Products Troponin I ES Calibrators Reagent packs could potentially contain incorrect wells, which will generate incorrect, and poten... Class II ORTHO-CLINICAL DIAGNOSTICS
Jun 5, 2023 Perifix¿ / Epidural anesthesia kit (10 count carton) Kits were assembled with the incorrect Filter Straw. Class II B. Braun Medical, Inc.
Jun 5, 2023 Verigene Enteric Pathogens Nucleic Acid Test (EP), REF 30-002-023 It is possible that in rare instances the VERIGENE CDF Nucleic Acid Test Kit (Part No. 20-005-022... Class II Luminex Corporation
Jun 5, 2023 Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0... An unexpected shutdown of the IABP may occur due to failures of tantalum capacitors in the Power... Class I Datascope Corp.
Jun 5, 2023 VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022 It is possible that in rare instances the VERIGENE CDF Nucleic Acid Test Kit (Part No. 20-005-022... Class II Luminex Corporation
Jun 5, 2023 Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0... An unexpected shutdown of the IABP may occur due to failures of tantalum capacitors in the Power... Class I Datascope Corp.
Jun 5, 2023 Cios Select VA 21 with FD- A Mobile X-ray system intended for use in Operatin... Incorrect glue was applied on the plexiglass sheet on the single tank cover assembly could potent... Class II Siemens Medical Solutions USA, Inc
Jun 5, 2023 Exactech Ergo Impactor Handle, Catalog #321-09-05. The ball and spring housed within the locking mechanism of the handle can dislodge during disasse... Class II Exactech, Inc.
Jun 5, 2023 Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0... IABP may lose the ability to charge batteries in one or both bay slots. Therapy may be interru... Class I Datascope Corp.
Jun 5, 2023 VITROS Immunodiagnostic Products Troponin I ES Reagent Pack Reagent packs could potentially contain incorrect wells, which will generate incorrect, and poten... Class II ORTHO-CLINICAL DIAGNOSTICS
Jun 5, 2023 Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0... IABP may lose the ability to charge batteries in one or both bay slots. Therapy may be interru... Class I Datascope Corp.
Jun 5, 2023 Design Options¿ / Epidural anesthesia kit (10 count carton) Kits were assembled with the incorrect Filter Straw. Class II B. Braun Medical, Inc.
Jun 2, 2023 Beckman Coulter DxA Automation System, DxA 5000, REF: B87352, IVD, 200240V, 1... A software defect in the DxA Automation System may cause tests to be run on patient samples in tu... Class II Beckman Coulter Biomedical GmbH
Jun 2, 2023 Beckman Coulter DxA Automation System, DxA 5000 Fit, REF: B87352, IVD, 200240... A software defect in the DxA Automation System may cause tests to be run on patient samples in tu... Class II Beckman Coulter Biomedical GmbH
Jun 2, 2023 Covidien Cytosponge Cell Collection Device, REF: CYTO-201; and Covidien Cytos... Cell Collection Device may be at increased risk of the sponge detaching from the string during re... Class II Covidien, LLC
Jun 1, 2023 epoc BGEM BUN Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Senso... There is potential for discrepant high glucose results in samples with glucose results on the low... Class II Siemens Healthcare Diagnostics Inc
Jun 1, 2023 MEGADYNE MEGA SOFT Universal Patient Return Electrode. used during electrosu... Firm has received reports of patient burns in surgical procedures where device was used. Class I Megadyne Medical Products, Inc.
Jun 1, 2023 MEGADYNE MEGA SOFT Dual Reusable Patient Return Electrode. used during elect... Firm has received reports of patient burns in surgical procedures where device was used. Class I Megadyne Medical Products, Inc.
Jun 1, 2023 epoc BGEM Test Card (BUN & TCO2),Veterinary with epoc Host SW v3.37.3, epoc N... There is potential for discrepant high glucose results in samples with glucose results on the low... Class II Siemens Healthcare Diagnostics Inc
Jun 1, 2023 MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode. used during... Firm has received reports of patient burns in surgical procedures where device was used. Class I Megadyne Medical Products, Inc.
Jun 1, 2023 MEGADYNE MEGA SOFT Reusable Patient Return Electrode. used during electrosur... Firm has received reports of patient burns in surgical procedures where device was used. Class I Megadyne Medical Products, Inc.
Jun 1, 2023 MEGADYNE MEGA 2000 Patient Return Electrode. used during electrosurgery Firm has received reports of patient burns in surgical procedures where device was used. Class I Megadyne Medical Products, Inc.
Jun 1, 2023 MEGADYNE MEGA SOFT Pediatric Patient Return Electrode. used during electrosu... Firm has received reports of patient burns in surgical procedures where device was used. Class I Megadyne Medical Products, Inc.
Jun 1, 2023 MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode. used during elec... Firm has received reports of patient burns in surgical procedures where device was used. Class I Megadyne Medical Products, Inc.
Jun 1, 2023 MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode. used during elec... Firm has received reports of patient burns in surgical procedures where device was used. Class I Megadyne Medical Products, Inc.
Jun 1, 2023 epoc BGEM Crea Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sens... There is potential for discrepant high glucose results in samples with glucose results on the low... Class II Siemens Healthcare Diagnostics Inc
May 31, 2023 COULTER DxH Diluent, REF 628017; diluent used for counting and sizing blood c... Specific diluent lot numbers showed that conductivity, osmolality, and pH were out of manufacturi... Class II Beckman Coulter, Inc.
May 31, 2023 UFSK Treatment chair 500 XLE- Treatment chair for positioning and support of ... Service life of the electrical seat part drive of the treatment chair may be shortened unexpected... Class II UFSK - International OSYS Gmbh
May 31, 2023 Trexo Device Electrical issues that could potentially render the device non-functional, give off electromagnet... Class II Trexo Robotics Holdings Inc.
May 31, 2023 REF 218-1604-SP-10, Profile 0 4mm AutoDrive Screw Sterile Qty 10, Rx Only, St... Screws for osteotomies have contain an undersize screwhead which has the potential to pass throug... Class II Osteomed, LLC
May 31, 2023 Remel Haemophilus Test Medium (Agar) (150mm), 10/pk, REF R04033; and Remel Ha... The test medium may not perform as intended. Class II Remel, Inc
May 31, 2023 REF: 218-1604, 1.6mm x 4mm Profile Zero Auto-Drive Screw, Rx Only, Sterile Screws for osteotomies have contain an undersize screwhead which has the potential to pass throug... Class II Osteomed, LLC
May 31, 2023 MICRO-X Rover Mobile X-ray System, # MXU-RV35 Shots were terminated by the mAs integrator; however, the 4 ms exposure time did not allow enough... Class II Micro-X Ltd.
May 30, 2023 ACETABULAR BEARING (xx)MM I.D X (xx) O.D. UHMWPE 1020, STERILEEO, Reference N... Medical device components were marketed without FDA clearance Class II Synovo Production
May 30, 2023 ACETABULAR FIXATION CUP, (xx)MM, 5 HOLE, Ti-6AI-4V ELI TiN CERAMIC W/PLASMA S... Medical device components were marketed without FDA clearance and without FDA approval Class II Synovo Production
May 30, 2023 REF 1975.14.500, Prima TT Genoid Monoblock Reverse TT Baseplate, STERILE R Due to manufacturing issue, their is a potential for peripheral holes to be out of specification. Class II Limacorporate S.p.A
May 30, 2023 GE Healthcare Vivid S60, ultrasound device GE HealthCare has become aware that certain Vivid ultrasound systems cannot boot up in a timely f... Class II GE Vingmed Ultrasound As
May 30, 2023 GE Healthcare Vivid S70, ultrasound device GE HealthCare has become aware that certain Vivid ultrasound systems cannot boot up in a timely f... Class II GE Vingmed Ultrasound As
May 30, 2023 REF 1975.14.800, Prima TT Genoid Modular Reverse TT Baseplate, Sterile R Due to manufacturing issue, their is a potential for peripheral holes to be out of specification. Class II Limacorporate S.p.A
May 30, 2023 Custom medical procedure packs labeled as: a) STANDARD OB PACK ASCENSION W... The outer package seal could be open, or compromised which affects the sterility of the procedure... Class II DeRoyal Industries Inc
May 30, 2023 Custom medical procedure packs labeled as: a) PELVIC EXAM TRAY, REF 89-6219 The outer package seal could be open, or compromised which affects the sterility of the procedure... Class II DeRoyal Industries Inc
May 30, 2023 GE Healthcare Vivid S70N, ultrasound device GE HealthCare has become aware that certain Vivid ultrasound systems cannot boot up in a timely f... Class II GE Vingmed Ultrasound As

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.