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Vehicle Safety

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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Bridge Safety624,000 bridge inspections Aviation Safety30,000+ NTSB aviation events Dam Safety92,600 dam safety records Water Safety433,000+ public water systems Railroad Safety438,000+ rail crossings Pipeline Safety8,800+ pipeline incidents State DashboardsSafety grades for all 50 states ZIP ReportAny 5-digit ZIP across 9 datasets

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Browse Device Recalls

797 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 797 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 797 FDA device recalls.

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DateProductReasonClassFirm
Apr 26, 2013 Vermed, Inc Radiotransparent Defibrillation Electrodes Monophasic or biphasi... On 4/18/13 HEARTSYNC became aware of a recall from their wire/connector sub-assembly supplier whi... Class II Heart Sync, Inc
Apr 26, 2013 Heart Sync C100-Physio Radiotransparent Defibrillation Electrodes Monophasic ... On 4/18/13 HEARTSYNC became aware of a recall from their wire/connector sub-assembly supplier whi... Class II Heart Sync, Inc
Mar 8, 2013 The LifeCare Pump Model 4200 PCA Infuser makes possible the practical impleme... Hospira has received reports of PCA pumps not detecting distal occlusions, one of which resulted ... Class II Hospira Inc.
Feb 8, 2013 Medtronic DBS Lead Kit for Deep Brain Stimulation, models 3387, 3387S, 3389, ... There is a potential for lead damage due to the use of the lead cap provided in DBS and Dystonia ... Class I Medtronic Neuromodulation
Jan 24, 2013 D3000 Advantage Drive System, 115v Product Usage: The Advantage Drive Sy... The Membrane Switch Panel (referred to as "front panel" of the component part number A34-003-207,... Class III Linvatec Corp. dba ConMed Linvatec
Jan 24, 2013 D3000I Advantage Drive System, 230v, surgical instrument motor. Product Us... The Membrane Switch Panel (referred to as "front panel" of the component part number A34-003-207,... Class III Linvatec Corp. dba ConMed Linvatec
Dec 18, 2012 Ad-Tech Medical Instrument Corporation Macro Micro Subdural Electrode. For t... The microelectrodes are not flush with the silastic substrate, may contain sharp edges capable of... Class I Ad-Tech Medical Instrument Corporation
Dec 11, 2012 GreenLight HPS (High Performance System) GreenLight XPS (Xcelerated Performa... During electrical recertification testing it was found that the Voltage Scaling Board was non-con... Class II AMS Innovative Center - San Jose
Nov 9, 2012 Medtronic SynchroMed II, Model 8637, (The SynchroMed¿ II Pump is supplied in ... Medtronic notified Healthcare Professionals of the impact of unapproved drugs on the performance ... Class I Medtronic Neuromodulation
Nov 9, 2012 SynchroMed EL, models 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10... Medtronic notified Healthcare Professionals of the impact of unapproved drugs on the performance ... Class I Medtronic Neuromodulation
Nov 2, 2012 Brookstone Heated Body Bean, electrically heated SKU numbers: 734863 (Blue)... Additional Warning Statement to prevent burns to the skin Class II Brookstone Company, Inc.
Sep 28, 2012 VENTANA (a member of the Roche Group) BenchMark ULTRA; REF/MU 750-600; Resear... Potiential for a waste fluid overflow condition to accur while running decontamination cycles on ... Class II Ventana Medical Systems Inc
Sep 25, 2012 Belmont Rapid Infuser, a Fluid Management System, Model FMS2000. Leak from a saline bag caused saline to drip along the back of the Rapid infuser close to the Po... Class II Belmont Instrument Corporation
Sep 19, 2012 S5 Mast Roller Pump 85, Item Number: 10-88-60 The Stockert S5/Sorin C5 Sys... Sorin Group USA, Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers o... Class II Sorin Group USA, Inc.
Sep 19, 2012 S5 Mast Roller Pump 150, Item Number: 10-88-00 The Stockert S5/Sorin C5 Sy... Sorin Group USA, Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers o... Class II Sorin Group USA, Inc.
Sep 19, 2012 S5 Single Roller Pump 150, Item Number: 10-80-00 The Stockert S5/Sorin C5 ... Sorin Group USA, Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers o... Class II Sorin Group USA, Inc.
Sep 19, 2012 S5 Double Roller Pump 85, Item Number: 10-85-00 The Stockert S5/Sorin C5 S... Sorin Group USA, Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers o... Class II Sorin Group USA, Inc.
Sep 19, 2012 Sorin C5 Perfusion System, Item number 58-00-00 The Stockert S5/Sorin C5 S... Sorin Group USA, Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers o... Class II Sorin Group USA, Inc.
Sep 13, 2012 3M Steri-Vac Gas Sterilizer/Aerator models 5XL and 8XL. 3M Steri-Vac Gas S... 3M determined that the electrical grounding mechanism for the Steri-Vac 5XL and 8XL gas Sterilize... Class II 3M Company - Health Care Business
Sep 6, 2012 Sterile, single-use, disposable electrosurgical electrode holder. It connect... The wrong electrical connector pin was attached to the cord during assembly by the manufacturer. ... Class III Gynex Corporation
Sep 4, 2012 The Eon Mini Implantable Pulse Generator (IPG) is a 16-channel, rechargeable,... Eon Mini IPGs manufactured in April 2012 could potentially exhibit a sudden, brief surge in stimu... Class II Advanced Neuromodulation Systems Inc.
Aug 1, 2012 DGPHP RFA High-Power Single Use Grounding Pads and Cool-Tip RFA Electrode Kit... Covidien is conducting a recall of various production lots of DGHP RFA High Power single use grou... Class II Nellcor Puritan Bennett Inc. (dba Covidien LP)
Jul 13, 2012 AUTOMIX 3+3 Compounder System, product 2M8286 (115V) and 2M8286K (230V), auto... After fluid ingress into the keypad of the AUTOMIX Compounder's (AUTOMIX) control module, the AUT... Class I Baxter Healthcare Corp.
Jul 13, 2012 AUTOMIX Plus High Speed Compounder System, product 2M8075; automated nutritio... After fluid ingress into the keypad of the AUTOMIX Compounder's (AUTOMIX) control module, the AUT... Class I Baxter Healthcare Corp.
Jul 13, 2012 AUTOMIX 3+3 Compounder with Accusource Monitoring System, product 2M8287; aut... After fluid ingress into the keypad of the AUTOMIX Compounder's (AUTOMIX) control module, the AUT... Class I Baxter Healthcare Corp.
Jul 13, 2012 AUTOMIX High Speed Compounder System, product 2M8077; automated nutrition com... After fluid ingress into the keypad of the AUTOMIX Compounder's (AUTOMIX) control module, the AUT... Class I Baxter Healthcare Corp.
Jun 15, 2012 AEM Disposable Electrodes, Device, Electrosurgical, Cutting and Coagulation a... Encision is performing a field correction to their AEM Disposable Electrodes due to two consumer ... Class II Encision, Inc.
May 25, 2012 Getinge brand --- large capacity, floor loading jet spray, washers for mechan... Getinge Disinfection AB is voluntarily correcting Washer Disinfectors, Getinge Electrically Heate... Class II Getinge USA Inc
May 16, 2012 Boston Scientific Profile Single-Use Pediatric Snare 27mm UPN Outer Box: M00... Difficulty in extending snare loop from the catheter Class II Boston Scientific Corporation
May 16, 2012 Boston Scientific Profile Single-Use Pediatric Snare 11mm UPN Outer Box M005... Difficulty in extending snare loop from the catheter Class II Boston Scientific Corporation
May 16, 2012 Boston Scientific Profile Single-Use Pediatric Snare 13mm UPN Outer Box: M00... Difficulty in extending snare loop from the catheter Class II Boston Scientific Corporation
Feb 9, 2012 Reusable, Self-Adhering TENS/NMES/FES electrodes Single Patient Use Only. ... Covidien is conducting a voluntary recall regarding specific lots of TENS electrodes because it w... Class II Covidien LLC dba Uni-Patch
Feb 9, 2012 Reusable, non-sterile, self-adhering electrodes for use with TENS/NMES, . Ma... Covidien is conducting a voluntary recall regarding specific lots of TENS electrodes because it w... Class II Covidien LLC dba Uni-Patch
Feb 9, 2012 Performa reusable and self-adhering TENS/NMES/FES stimulating electrodes, ... Covidien is conducting a voluntary recall regarding specific lots of TENS electrodes because it w... Class II Covidien LLC dba Uni-Patch
Feb 9, 2012 Empi STIMC RE Self Adhesive electrodes. For use on TENS, NMES, FES. a DJO b... Covidien is conducting a voluntary recall regarding specific lots of TENS electrodes because it w... Class II Covidien LLC dba Uni-Patch
Sep 23, 2011 Tip Cover Accessory, 8 MM, MCS, box of 10 Product Usage: The disposable T... Clarification of existing labeling and related cautions for the tip cover accessory of the da Vin... Class II Intuitive Surgical, Inc.
Mar 4, 2011 Mini-Infuser Model 300XL Multispeed Infusion Pump, an Rx battery operated syr... Should a battery with the minimum contact diameter (.51 inches) be placed on the battery spring (... Class III Baxter Healthcare Corp.
Mar 4, 2011 Mini-Infuser Model 150XL Single Speed Infusion Pump, an Rx battery operated s... Should a battery with the minimum contact diameter (.51 inches) be placed on the battery spring (... Class III Baxter Healthcare Corp.
Jan 17, 2011 Automated Impella Controller (AIC) with the below product descriptions and co... Retrospective submission for following issues identified: 1. Alarm failures, power-path faults,... Class I Abiomed, Inc.
Nov 30, 2009 Cloth electrodes with Carbon construction: P/N 201-1231, Cat Nos.: 201-123... Electrode Socket Terminal pulling away from the electrode lead wire when the electrical stim lead... Class II NAImco Inc dba Richmar Inc
Nov 30, 2009 Cloth electrodes with Silver-Carbon construction: P/N 202-9231, Cat No. 400-... Electrode Socket Terminal pulling away from the electrode lead wire when the electrical stim lead... Class II NAImco Inc dba Richmar Inc
Nov 30, 2009 Foam electrodes with Silver-Carbon construction: P/N 202-9271, Cat No. 400-8... Electrode Socket Terminal pulling away from the electrode lead wire when the electrical stim lead... Class II NAImco Inc dba Richmar Inc
Nov 30, 2009 Foam Electrodes with Carbon construction: P/N 201-1261, Cat Nos.: 201-126, 2... Electrode Socket Terminal pulling away from the electrode lead wire when the electrical stim lead... Class II NAImco Inc dba Richmar Inc
Nov 17, 2009 CARTO 3 V1.05(FG-5400-00). The CARTO 3 V1.05 System is intended for cathet... The recall was initiated because Biosense Webster has become aware of information regarding a pot... Class II Biosense Webster, Inc.
Jan 25, 2009 IF 8000; 1/F Interferential Electrical Stimulation Device; NMES (neuromuscula... Zynex notified customers that a malfunction in the IF 8000 can result in the device ceasing to op... Class II Zynex Medical, Inc.
May 1, 2008 PT Link Waterbath, Model#PT100. Lab Vision PT Module Plus provides an auto... Dako is recalling the PT Link Waterbath because of a possible electrical hazard. Specifically, ... Class II Dako North America Inc.
Sep 14, 2007 HiRes 90K devices with Helix Electrodes Model CI 1400-02H The HiResolution... Advanced Bionics is recalling the the HiRes 90K cochlear implant with HiFocus Helix Electrode bec... Class II Advanced Bionics Corporation

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.