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Browse Device Recalls

780 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 780 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 780 FDA device recalls.

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DateProductReasonClassFirm
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.
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.