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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

2,522 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,522 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 2,522 FDA device recalls.

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DateProductReasonClassFirm
Dec 24, 2013 6" (15 cm) Appx 0.27 ml, Smallbore Ext Set w/Clamp, NanoClave" TConnector w/... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, Inc.
Dec 24, 2013 8" Ext Set w/NanoClave" Stopcock, Clamp, Rotating Luer, Part No. A1000, Item... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, Inc.
Dec 24, 2013 78" Ext Set w/Check Valve, CLAVE¿ Clear, Remv 2 Gang 4-Way Stopcocks, NanoCl... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, Inc.
Dec 24, 2013 6" (15 cm) Appx 0.27 ml, Smallbore Ext Set w/Clamp, NanoClave" TConnector, R... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, Inc.
Dec 24, 2013 8" (20 cm) Appx 0.43 ml, Smallbore Bifuse Ext Set w/2 NanoClave", 2 Clamps, ... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, Inc.
Dec 24, 2013 17 cm (7") Smallbore Trifuse Ext Set w/3 NanoClave¿ ( Light Blue, Lavender R... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, Inc.
Dec 24, 2013 28" (71 cm) Appx 1.0 ml, Smallbore Ext Set w/Anti-Siphon Valve, MicroClave¿ ... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, Inc.
Dec 24, 2013 13" Pentafuse Smallbore Ext Set w/NanoClave", 1.2 Micron Filter, 3 MicroClav... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, Inc.
Dec 24, 2013 106" (269 cm) Appx 7.8 ml, Transfer Set w/Check Valve, NanoClave" TConnector,... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, Inc.
Dec 24, 2013 31 cm (12") Smallbore Bifuse Ext Set w/2 NanoClave¿, Orange Ring, 2 Anti Syp... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, Inc.
Dec 24, 2013 10" Smallbore Pentafuse Ext Set w/5 NanoClave", 5 Clamps, Rotating Luer, Par... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, Inc.
Dec 24, 2013 NanoClave Stopcock, Part No. A1000, Item No. 011-AC100 The ICU Needleless Co... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, Inc.
Dec 24, 2013 6" (15 cm) Appx 0.37 ml, Smallbore Bifuse Ext Set w/2 NanoClave", 2 Clamps, ... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, Inc.
Dec 24, 2013 183 cm (72") Smallbore Quadfuse Ext Set w/4 NanoClave¿ (Yellow, Green Rings)... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, Inc.
Dec 24, 2013 14" (36 cm ) Appx 0.50 ml, Smallbore Ext Set w/MicroClave¿ Clear, NanoClave¿... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, Inc.
Dec 24, 2013 103" (262 cm) Appx 3.9 ml, Smallbore Bifuse Ext Set w/NanoClave", Anti-Sipho... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, Inc.
Dec 24, 2013 6" (15 cm) Appx 0.58 ml, Smallbore Trifuse Ext Set w/3 NanoClave¿, 3 Clamps,... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, Inc.
Dec 24, 2013 78" Ext Set w/2 BCV-Clave¿, Remv 2-Gang 4-Way Stopcocks, NanoClave" T-Connec... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, Inc.
Dec 24, 2013 5" Smallbore Ext Set w/MicroClave¿ T-Connector, Clamp, Luer Slip, Item # B330... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, Inc.
Dec 24, 2013 5" Smallbore Ext Set w/MicroClave¿ T-Connector, Clamp, Rotating Luer, Item #... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, Inc.
Dec 24, 2013 7" (18 cm) Appx 0.31 ml, Smallbore Ext Set w/Remv MicroClave¿ Clear, NanoCla... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, Inc.
Dec 10, 2013 Trabecular Metal (TM) Reverse Glenosphere 36mm Part 00-4349-036-11 The r... Zimmer is initiating a lot specific recall of the CPT Hip Stem, Versys Build-Up Block, and Trabec... Class II Zimmer, Inc.
Dec 10, 2013 Philips HeartStart MRx Monitor/Defibrillator with CO2/EtCO2 Measurement T... MRx defibrillator displays a -?- for EtCO2 and does not display EtCO2 values when patient CO2 lev... Class II Philips Medical Systems, Inc.
Dec 6, 2013 Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device) Catal... The housing to the Pump's driveline connector became partially or fully separated from the front ... Class I HeartWare Inc
Dec 5, 2013 GE Healthcare, TRAM MODULE, High-acuity patient monitoring. Product Usage: Th... Intermittent noise on ECG and/or Respiration waveforms associated with movement of the ECG cable ... Class II GE Healthcare, LLC
Dec 5, 2013 SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthc... Intermittent noise on ECG and/or Respiration waveforms associated with movement of the ECG cable ... Class II GE Healthcare, LLC
Nov 19, 2013 NexGen Complete Knee Solution CR Articular Surface Provisional-Striped Green... This is an expansion of the June 2013 recall of NexGen Micro components. Five (5) additional ins... Class II Zimmer, Inc.
Nov 19, 2013 NexGen Complete Knee Solution CR Articular Surface Provisional-Purple 9mm He... This is an expansion of the June 2013 recall of NexGen Micro components. Five (5) additional ins... Class II Zimmer, Inc.
Nov 19, 2013 NexGen Complete Knee Solution CR Articular Surface Provisional-Yellow 9mm He... This is an expansion of the June 2013 recall of NexGen Micro components. Five (5) additional ins... Class II Zimmer, Inc.
Nov 13, 2013 Integra Small Rickham -Style Reservoir Rx Only Sterile for Single Use Only ... Integra became aware through an adverse complaint trend that Rickham Style Reservoirs with bent o... Class II Integra LifeSciences Corp.
Nov 13, 2013 Broncho Flexible Fiberscope, models: 11001BN1, 11002BD1, 11004BC1, and 11009B... KARL STORZ Endoscopy America, Inc. is recalling the Flexible Broncho Fiberscope or a Flexible Int... Class II Karl Storz Endoscopy America Inc
Nov 13, 2013 Integra Large Rickham -Style Reservoir Rx Only Sterile for Single Use Only ... Integra became aware through an adverse complaint trend that Rickham Style Reservoirs with bent o... Class II Integra LifeSciences Corp.
Nov 8, 2013 Coulter DxH Cleaner 10L, Part No. 628023. For use on UniCel DxH Systems fo... Beckman Coulter is recalling the UniCel DxH800 and UniCel DxH600 Coulter Analysis Systems because... Class II Beckman Coulter Inc.
Nov 8, 2013 Coulter LH 750 Hematology Analyzer, Part No. 6605632, A85570 Product Usag... Beckman Coulter is recalling the LH 750 and LH 780 Hematology Systems because the optical degrada... Class II Beckman Coulter Inc.
Nov 8, 2013 Coulter DxH Cleaner 5L, Part No. 628022. For use on UniCel DxH Systems for... Beckman Coulter is recalling the UniCel DxH800 and UniCel DxH600 Coulter Analysis Systems because... Class II Beckman Coulter Inc.
Nov 8, 2013 Coulter LH 780 Hematology Analyzer, Part No. 723585, A90728 Product Usage... Beckman Coulter is recalling the LH 750 and LH 780 Hematology Systems because the optical degrada... Class II Beckman Coulter Inc.
Nov 8, 2013 UniCel DxH 600 Coulter Cellular Analysis System, Part No. B23858. Used for... Beckman Coulter is recalling the UniCel DxH800 and UniCel DxH600 Coulter Analysis Systems because... Class II Beckman Coulter Inc.
Nov 8, 2013 UniCel DxH 800 Coulter Cellular Analysis System, Part No. 629029, B24465, a... Beckman Coulter is recalling the UniCel DxH800 and UniCel DxH600 Coulter Analysis Systems because... Class II Beckman Coulter Inc.
Oct 31, 2013 NexGen¿ Complete Knee Solutions Stemmed Tibial Component Precoat NexGen Ti... Two complaints were received in which it was reported that the stem would not lock into the tibia... Class II Zimmer, Inc.
Oct 25, 2013 REF 200068 Security (TM) Enclosed Carpal Tunnel System Blade ( Single) ABS /... Security Blades were manufactured oversized and potentially won't advance or may be difficult to ... Class II Biomet, Inc.
Oct 23, 2013 ALTRUS¿ THERMAL TISSUE FUSION, Tissue Fusion Handpiece, 5 mm O.D., 36 cm Shaf... The affected lots were exposed to a higher than acceptable level of particulate matter during man... Class II ConMed Corporation
Oct 23, 2013 ALTRUS¿ THERMAL TISSUE FUSION, Tissue Fusion Handpiece, 5 mm O.D., 16 cm Shaf... The affected lots were exposed to a higher than acceptable level of particulate matter during man... Class II ConMed Corporation
Oct 23, 2013 Sarns" Soft-Flow¿ Aortic Cannula without Suture Flange, angled tip, wire-rei... During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presen... Class II Terumo Cardiovascular Systems Corporation
Oct 23, 2013 Sarns" Venous Return Cannulae, 20 Fr with 1/4" flare, 14.5" (37 cm) long. ... During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presen... Class II Terumo Cardiovascular Systems Corporation
Oct 23, 2013 Sarns" Soft-Flow¿ Aortic Cannula without Suture Flange, straight tip, wire-r... During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presen... Class II Terumo Cardiovascular Systems Corporation
Oct 23, 2013 Sarns" Soft-Flow¿ Aortic Cannula without Suture Flange, straight tip, wire-r... During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presen... Class II Terumo Cardiovascular Systems Corporation
Oct 21, 2013 ATTAIN HYBRID¿ Guide Wire; Models: GWR419478, GWR419488, GWR419688 The Att... Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire. Class I Medtronic Vascular
Oct 13, 2013 Sterile Disposable Kit ( Contains Skin Tensioner ASY-25067; Three Mark Needl... Reports of discoloration (residue) on the pins of the skin tensioner have been received by severa... Class II Restoration Robotics
Oct 13, 2013 ARTAS Disposable and Reuseable Kit ( Contains Skin Tensioner FP-45384; Inn... Reports of discoloration (residue) on the pins of the skin tensioner have been received by severa... Class II Restoration Robotics
Oct 13, 2013 ARTAS Disposable Kit ( Contains Skin Tensioner FP-45384; Inner Needle with Va... Reports of discoloration (residue) on the pins of the skin tensioner have been received by severa... Class II Restoration Robotics

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.