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Browse Device Recalls

723 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 723 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 723 FDA device recalls.

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DateProductReasonClassFirm
Jun 12, 2012 Carestream DRX-1 System Battery --- Made in U.S.A. for Carestream Health, Inc... Carestream DRX-1 System batteries manufactured before June 2012 due to two occurrences of lithium... Class II Carestream Health, Inc.
May 25, 2012 Alaris PC unit model 8015 Product Usage: The device is labeled for prescr... The recall was initiated because the Alaris PC unit model 8015 has a component on the PC unit pow... Class I CareFusion 303, Inc.
Apr 27, 2012 Patient Side Cart Battery Box used in conjunction with the da Vinci A surgica... Patient Side Cart battery boxes may overheat in rare charging conditions, causing battery bulging. Class II Intuitive Surgical, Inc.
Apr 6, 2012 TDX SP Power Wheelchair, TDX SR Power Wheelchair, TDX SI Power Wheelchair. Mo... Invacare Corporation decided to recall the product because of a potential risk of fire and seriou... Class II Invacare Corporation
Mar 23, 2012 Colgate Adult Motion Whitening Battery Toothbrush UPC 035000691507 Dist. b... Brush battery cap was forcibly blown off at the end of the brush handle. Class II Colgate Palmolive Company
Mar 23, 2012 Colgate 360 Replaceable Head Battery Powered Toothbrush Medium UPC03500068750... Brush battery cap was forcibly blown off at the end of the brush handle. Class II Colgate Palmolive Company
Mar 23, 2012 Colgate 360 Replaceable Head Battery Powered Toothbrush Soft UPC 03500068747 ... Brush battery cap was forcibly blown off at the end of the brush handle. Class II Colgate Palmolive Company
Mar 23, 2012 Colgate Adult Motion Battery Toothbrush UPC 035000686213 Dist. by Colgate... Brush battery cap was forcibly blown off at the end of the brush handle. Class II Colgate Palmolive Company
Mar 23, 2012 Colgate 360 Replaceable Head Battery Powered Bonus Twin Pack Toothbrush Soft ... Brush battery cap was forcibly blown off at the end of the brush handle. Class II Colgate Palmolive Company
Feb 24, 2012 Lithium Thionyl non-rechargeable disposable battery pack P/N 350-0294-01 used... Braemar has recently became aware of a battery related incident that occurred with EWT battery pa... Class II BRAEMAR, INC.
Feb 12, 2012 The Symbionic Leg is an integrated prosthetic leg for transfemoral and knee d... OSSUR initiated this recall of the Symbionic Leg because it may have a possible defect in a small... Class II Ossur Americas, Inc.
Dec 19, 2011 Eon Mini Neurostimulation (IPG) System (Model 3788); The product is indica... The firm has received 112 complaints of the Eon Mini IPGs that lost the ability to communicate or... Class II Advanced Neuromodulation Systems Inc.
Dec 5, 2011 Sunquest Laboratory Versions 6.4 and later using Microbiology Result Entry The recall was initiated because Sunquest has confirmed that the Sunquest Laboratory versions 6.4... Class II Sunquest Information Systems, Inc.
Sep 8, 2011 iStat1 Analyzer Abbott Point of Care, Princeton, NJ 08540 Model 200. The ... Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a reca... Class II Abbott Point Of Care Inc.
Sep 8, 2011 i-Stat Portable Clinical Analyzer; Abbott Point of Care, Princeton, NJ 08540 ... Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a reca... Class II Abbott Point Of Care Inc.
Sep 8, 2011 Military Kit Portable Clinical Analyzer ; Abbott Point of Care, Princeton, N... Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a reca... Class II Abbott Point Of Care Inc.
Sep 8, 2011 i-STAT1 Abaxis Analyzer; Abbott Point of Care, Princeton, NJ 08540 Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a reca... Class II Abbott Point Of Care Inc.
Sep 8, 2011 i-STAT1 Abaxis Analyzer; Abbott Point of Care, Princeton, NJ 08540 Model 2... Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a reca... Class II Abbott Point Of Care Inc.
Sep 8, 2011 Fuso Analyzer 300F; Abbott Point of Care, Princeton, NJ 08540 Model 200. T... Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a reca... Class II Abbott Point Of Care Inc.
May 2, 2011 Lithium Thionyl non-rechargeable disposable battery pack P/N 350-0294-00 used... Braemar Inc., became aware of a battery related incident that occurred with an Able battery pack... Class II BRAEMAR, 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.
Jul 1, 2005 Siemens Prisma 2K Hearing Aid Product Usage: A behind the ear (BTE) heari... Siemens became aware of an issue where an infant or child could open the tamper resistant battery... Class II Siemens Hearing Instruments, Inc

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.