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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

39,969 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 39,969 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 39,969 FDA device recalls.

DateProductReasonClassFirm
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
May 30, 2023 Custom medical procedure packs labeled as: a) STURDI STRAINER TRAY STANDAR... 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) OPEN HEART TRACECART, REF... 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) CATH ANGIOGRAPHY DRAPE PACK,... The outer package seal could be open, or compromised which affects the sterility of the procedure... Class II DeRoyal Industries Inc
May 30, 2023 Femoral Resurfacing Cup - (xx)MM, Ti-6AI-4V ELI, TiN CERAMIC W/ PLASMA SPRAY,... Medical device components were marketed without FDA clearance Class II Synovo Production
May 30, 2023 GE Healthcare Vivid S60N, 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 Alinity ci-series System Control Module, REF: 03R70-01 There are potential performance issues found in the Alinity ci-series System software versions 3.... Class II Abbott Laboratories
May 30, 2023 VERITAS Advanced Infusion Packs (VRT-AI) and VERITAS Advanced Fluidics Packs ... Weld protrusion/physical gap between the housing and pack cover, may exceed design specification,... Class II Johnson & Johnson Surgical Vision, Inc.
May 26, 2023 Olympus Endoscope Reprocessor OER-Pro-For use in cleaning and high-level disi... Revised OER-Pro, OER-Elite, OER-Mini endoscope reprocessor labeling- the LF-V and LF-P are no lon... Class II Olympus Corporation of the Americas
May 26, 2023 Abiomed 14Fr Low Profile Introducer Set, Product Number 1000457 There was one complaint that the sidearm of the device detached during explant of a pump. When t... Class II Abiomed, Inc.
May 26, 2023 VISERA Tracheal Intubation Videoscope OLYMPUS LF Type V- For airway managemen... Revised OER-Pro, OER-Elite, OER-Mini endoscope reprocessor labeling- the LF-V and LF-P are no lon... Class II Olympus Corporation of the Americas
May 26, 2023 Olympus Endoscope Reprocessor OER-Elite-For use in cleaning and high-level di... Revised OER-Pro, OER-Elite, OER-Mini endoscope reprocessor labeling- the LF-V and LF-P are no lon... Class II Olympus Corporation of the Americas
May 26, 2023 Olympus Endoscope Reprocessor OER-Mini-For use in cleaning and high-level dis... Revised OER-Pro, OER-Elite, OER-Mini endoscope reprocessor labeling- the LF-V and LF-P are no lon... Class II Olympus Corporation of the Americas
May 26, 2023 Tracheal Intubation Fiberscope OLYMPUS LF-P- To be used with an Olympus Light... Revised OER-Pro, OER-Elite, OER-Mini endoscope reprocessor labeling- the LF-V and LF-P are no lon... Class II Olympus Corporation of the Americas
May 25, 2023 Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 150020 Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affec... Class I TELEFLEX LLC
May 25, 2023 Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cu... Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affec... Class I TELEFLEX LLC
May 25, 2023 Flexiva Pulse ID 242 TracTip single Use Fiber-intended to be used as a device... Manufactured with the incorrect component may result in lower power output and degradation or dim... Class II Boston Scientific Corporation
May 25, 2023 Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cu... Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affec... Class I TELEFLEX LLC
May 25, 2023 Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 1700100 Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affec... Class I TELEFLEX LLC
May 25, 2023 Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF ... Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affec... Class I TELEFLEX LLC
May 25, 2023 Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cu... Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affec... Class I TELEFLEX LLC
May 25, 2023 RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill, REF 112480025 Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affec... Class I TELEFLEX LLC
May 25, 2023 Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170075 Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affec... Class I TELEFLEX LLC
May 25, 2023 Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100180055 Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affec... Class I TELEFLEX LLC
May 25, 2023 Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504570 Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affec... Class I TELEFLEX LLC
May 25, 2023 Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170150 Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affec... Class I TELEFLEX LLC
May 25, 2023 Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380035 Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affec... Class I TELEFLEX LLC
May 25, 2023 Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cu... Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affec... Class I TELEFLEX LLC
May 25, 2023 Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF ... Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affec... Class I TELEFLEX LLC
May 25, 2023 Flexi-Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 506540 Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affec... Class I TELEFLEX LLC
May 25, 2023 Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380040 Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affec... Class I TELEFLEX LLC
May 25, 2023 Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100180045 Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affec... Class I TELEFLEX 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.