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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

Infrastructure

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

740 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 740 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 740 FDA device recalls.

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DateProductReasonClassFirm
Sep 25, 2012 Perfusion System 8000, base 4 pump, 115V safety monitor included The Sarns... Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various ma... Class II Terumo Cardiovascular Systems Corporation
Sep 25, 2012 Perfusion System 8000, base 5 pump, 115V safety monitor included The Sarns... Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various ma... Class II Terumo Cardiovascular Systems Corporation
Sep 25, 2012 Perfusion System 8000, base 5 pump, 100V safety monitor included The Sarns... Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various ma... Class II Terumo Cardiovascular Systems Corporation
Sep 25, 2012 Perfusion System 8000, base 5 pump, 220V/240V safety monitor included The ... Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various ma... Class II Terumo Cardiovascular Systems Corporation
Sep 25, 2012 Battery, 100/115V (Includes charger and connecting cable) The Sarns" Centr... Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2004 of various m... Class II Terumo Cardiovascular Systems Corporation
Sep 25, 2012 Battery, 220V (Includes charger and connecting cable) The Sarns" Centrifug... Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2004 of various m... Class II Terumo Cardiovascular Systems Corporation
Sep 11, 2012 Philips HeartStart XL M4735A Defibrillator/Monitors, used with the M3516A bat... HeartStart XL Defibrillator/Monitor (M4735A) used on a patient when AC power is not in use, with ... Class II Philips Healthcare Inc.
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 8, 2012 Positron Emission Tomography (PET) and X-ray Computed Tomography, GEMINI TF 1... Philips became aware of an issue relating to a UPS battery cabinet that appeared to have burned a... Class II Philips Medical Systems (Cleveland) Inc
Jul 26, 2012 Eon Mini - 3788 (IPG), Eon Mini system is indicated as an aid in the mana... As part of St. Jude Medical's routine tracking and product monitoring, they have received a total... Class II St. Jude Medical
Jul 6, 2012 Finapres Medical Systems Portapres with NiMh battery pack Product Usage:... Battery may become hot and leak Class II FMS, Finapres Medical Systems BV
Jun 27, 2012 Powered Mobility Offers Versatility (M¿V)TM Chair. The Powered MOV Chair m... Paramed Corporation (d/b/a, Descent Control Systems), a manufacturer and distributor of patient t... Class II Stryker Medical Division of Stryker Corporation
Jun 27, 2012 Powered Mobility Offers Versatility (M¿V)TM Chair. The Powered MOV Chair m... Paramed Corporation (d/b/a, Descent Control Systems), a manufacturer and distributor of patient t... Class II Stryker Medical Division of Stryker Corporation
Jun 27, 2012 Powered Mobility Offers Versatility (M¿V)TM Chair The Powered MOV Chair mo... Paramed Corporation (d/b/a, Descent Control Systems), a manufacturer and distributor of patient t... Class II Stryker Medical Division of Stryker Corporation
Jun 27, 2012 Powered Mobility Offers Versatility (M¿V)TM Chair The Powered MOV Chair mo... Paramed Corporation (d/b/a, Descent Control Systems), a manufacturer and distributor of patient t... Class II Stryker Medical Division of Stryker Corporation
Jun 22, 2012 System 1 Base, 100/120V The Terumo Advanced Perfusion System 1 is indicat... Terumo Advanced Perfusion System 1 battery charge is being depleted faster than expected during p... Class II Terumo Cardiovascular Systems Corporation
Jun 22, 2012 System 1 Base, 220/240V The Terumo Advanced Perfusion System 1 is indicated... Terumo Advanced Perfusion System 1 battery charge is being depleted faster than expected during p... Class II Terumo Cardiovascular Systems Corporation
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.