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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
Apr 2, 2018 AesDex, LLC Cardica C-Port Flex-A PLUS Distal Anastomosis System, Catalog N... Following pressurization of the devices, damage to the device handle mechanism may occur, accompa... Class II AESDEX
Mar 30, 2018 smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 1-2 Size, 9 MM, ... The affected products were inadvertently packaged with the inner packaging pouch being sealed tog... Class II Smith & Nephew, Inc.
Mar 30, 2018 smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 11 MM,... The affected products were inadvertently packaged with the inner packaging pouch being sealed tog... Class II Smith & Nephew, Inc.
Mar 30, 2018 smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 10 MM,... The affected products were inadvertently packaged with the inner packaging pouch being sealed tog... Class II Smith & Nephew, Inc.
Mar 30, 2018 smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 9 MM, ... The affected products were inadvertently packaged with the inner packaging pouch being sealed tog... Class II Smith & Nephew, Inc.
Mar 22, 2018 Cook Vacuum Pump (Cook Aspiration Unit) K-MAR-5200-US, GPN G51607. Intende... Pump was found to be constructed from crimp connectors that do not meet the fixation wiring requi... Class II Cook Inc.
Mar 22, 2018 Cook Vacuum Pump ( Cook Aspiration Unit) K-MAR-5200-US, GPN G49275. Intend... Pump was found to be constructed from crimp connectors that do not meet the fixation wiring requi... Class II Cook Inc.
Mar 14, 2018 PHILIPS Xper Flex Cardio Physiomonitoring System, Model Numbers: 45356424190... The real-time numeric value for ventricular end-diastolic pressure (EDP) displayed on the Live Di... Class II Invivo Corporation
Mar 2, 2018 BECKMAN COULTER iChemVELOCITY, Urine Chemistry System, Catalog Numbers: 800-... Beckman Coulter has determined that there is a potential for incorrect settings to be installed o... Class II Beckman Coulter Inc.
Mar 1, 2018 6" Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, Clamp, Rotatin... ICU Medical is expanding the scope of their previously initiated recall to include additional I.V... Class II ICU Medical de Mexico, S.A. de C.V.
Mar 1, 2018 28 cm (11") PUR Bifuse Ext Set w/6-Port NanoClave Manifold, Check Valve, 2 Na... ICU Medical is expanding the scope of their previously initiated recall to include additional I.V... Class II ICU Medical de Mexico, S.A. de C.V.
Mar 1, 2018 11" Smallbore Ext Set w/NanoClave, 6-Port NanoClave Manifold, Check Valve, Cl... ICU Medical is expanding the scope of their previously initiated recall to include additional I.V... Class II ICU Medical de Mexico, S.A. de C.V.
Mar 1, 2018 PROXIMALE - 28 cm (11") Smallbore Ext Set w/6-Port NanoClave Manifold, Check ... ICU Medical is expanding the scope of their previously initiated recall to include additional I.V... Class II ICU Medical de Mexico, S.A. de C.V.
Mar 1, 2018 30 cm (12") PUR Bifuse Ext Set w/3-Port NanoClave Manifold, Check Valve, 2 Na... ICU Medical is expanding the scope of their previously initiated recall to include additional I.V... Class II ICU Medical de Mexico, S.A. de C.V.
Mar 1, 2018 10" Smallbore Ext Set w/6-Port NanoClave Manifold (Orange, Red, Blue, Purple,... ICU Medical is expanding the scope of their previously initiated recall to include additional I.V... Class II ICU Medical de Mexico, S.A. de C.V.
Mar 1, 2018 43 cm (17") Smallbore Ext Set w/3-Port NanoClave Manifold, Check Valve, NanoC... ICU Medical is expanding the scope of their previously initiated recall to include additional I.V... Class II ICU Medical de Mexico, S.A. de C.V.
Mar 1, 2018 61 cm (24") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, Micro... ICU Medical is expanding the scope of their previously initiated recall to include additional I.V... Class II ICU Medical de Mexico, S.A. de C.V.
Mar 1, 2018 216 cm (85") PVC/PUR Smallbore Bifuse Ext Set w/3-Port NanoClave Manifold, Ch... ICU Medical is expanding the scope of their previously initiated recall to include additional I.V... Class II ICU Medical de Mexico, S.A. de C.V.
Mar 1, 2018 Kit w/3 Ext Sets, 3 Drop-In MicroClave Clear ICU Medical is expanding the scope of their previously initiated recall to include additional I.V... Class II ICU Medical de Mexico, S.A. de C.V.
Mar 1, 2018 18 cm (7") PUR Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, Na... ICU Medical is expanding the scope of their previously initiated recall to include additional I.V... Class II ICU Medical de Mexico, S.A. de C.V.
Mar 1, 2018 165 cm (65") PUR Smallbore Ext Set w/3-Port NanoClave Manifold, Check Valve, ... ICU Medical is expanding the scope of their previously initiated recall to include additional I.V... Class II ICU Medical de Mexico, S.A. de C.V.
Mar 1, 2018 DISTALE - 203 cm (80") Bifuse Ext Set w/6 Gang 1o2 Manifold, 8 MicroClave Cle... ICU Medical is expanding the scope of their previously initiated recall to include additional I.V... Class II ICU Medical de Mexico, S.A. de C.V.
Mar 1, 2018 10" Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, Clamp, Rotati... ICU Medical is expanding the scope of their previously initiated recall to include additional I.V... Class II ICU Medical de Mexico, S.A. de C.V.
Mar 1, 2018 10" Smallbore Ext Set w/6-Port NanoClave Manifold (Orange, Red, Blue, Purple,... ICU Medical is expanding the scope of their previously initiated recall to include additional I.V... Class II ICU Medical de Mexico, S.A. de C.V.
Mar 1, 2018 20 cm (8") PUR Smallbore Ext Set w/3-Port NanoClave Manifold, Check Valve, Na... ICU Medical is expanding the scope of their previously initiated recall to include additional I.... Class II ICU Medical de Mexico, S.A. de C.V.
Mar 1, 2018 191 cm (75") Appx 2.9 ml, PVC/PUR Smallbore Bifuse Ext Set w/6-Port NanoClave... ICU Medical is expanding the scope of their previously initiated recall to include additional I.V... Class II ICU Medical de Mexico, S.A. de C.V.
Mar 1, 2018 40 cm (16") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, NanoC... ICU Medical is expanding the scope of their previously initiated recall to include additional I.V... Class II ICU Medical de Mexico, S.A. de C.V.
Mar 1, 2018 PROXIMALE - 18 cm (7") Appx 0.92 ml, PUR Smallbore Ext Set, 6-Port NanoClave ... ICU Medical is expanding the scope of their previously initiated recall to include additional I.V... Class II ICU Medical de Mexico, S.A. de C.V.
Mar 1, 2018 38 cm (15") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, Micro... ICU Medical is expanding the scope of their previously initiated recall to include additional I.V... Class II ICU Medical de Mexico, S.A. de C.V.
Feb 5, 2018 7" Smallbore Ext Set w/MicroClave¿, Clave¿ T-Connector, Clamp, Rotating Luer,... The infusion sets were manufactured with an incorrect spin collar. Class II ICU Medical, Inc.
Feb 5, 2018 6.5" (17 cm) Appx. 0.57 ml, Trifuse Ext Set w/3 MicroClave¿ Clear, NanoClave¿... The infusion sets were manufactured with an incorrect spin collar. Class II ICU Medical, Inc.
Feb 5, 2018 7" Ext Set w/MicroClave¿, Clave¿ T-Connector, Clamp, Rotating Luer, 50 pouche... The infusion sets were manufactured with an incorrect spin collar. Class II ICU Medical, Inc.
Feb 5, 2018 5" (13 cm) Smallbore Ext Set w/MicroClave¿, Clave¿ T-Connector, Clamp, Rotati... The infusion sets were manufactured with an incorrect spin collar. Class II ICU Medical, Inc.
Feb 5, 2018 14 cm (5.5") Appx 0.27 ml, Smallbore Ext Set w/SURPLUG¿ Nano T-Connector, Cla... The infusion sets were manufactured with an incorrect spin collar. Class II ICU Medical, Inc.
Feb 5, 2018 6.5" (17 cm) Smallbore Ext Set w/Remv MicroClave¿ Clear, NanoClave¿ T-Connect... The infusion sets were manufactured with an incorrect spin collar. Class II ICU Medical, Inc.
Feb 2, 2018 Signature Ceramic Femoral Head. Model Number: 111-152-621. The Signature cer... This recall has been identified due to the batch being mislabeled, with the packaged component's... Class II Signature Orthopedics Pty Limited
Jan 22, 2018 Apollo XT Suture Anchor, 5.5 x 15 Product Usage: Apollo XT Suture Anchors... The label on Apollo XT 5.5mm Suture Anchor (part # XTS-5515; lots 2358, 2362, and 2363) indicated... Class II Valeris Medical, LLC
Jan 5, 2018 Hemodynamic monitoring system (HMS), comprised of a Patient Interface Module ... When continuous cardiac output monitoring with a pulmonary artery catheter is placed in the Pau... Class II ICU Medical, Inc.
Jan 2, 2018 Roche Acetaminophen assay 03255379160-HAcetaminophen (P) 20767174160- cobas... The previous version of method sheets for the Acetaminophen assay on the COBAS INTEGRA 400 plus/... Class II Roche Diagnostics Corporation
Dec 19, 2017 Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Claria MRI. Label... Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibri... Class I Medtronic Inc., Cardiac Rhythm and Heart Failur...
Dec 19, 2017 Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Amplia MRI. Label... Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibri... Class I Medtronic Inc., Cardiac Rhythm and Heart Failur...
Dec 19, 2017 Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Compia MRI. Label... Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibri... Class I Medtronic Inc., Cardiac Rhythm and Heart Failur...
Dec 19, 2017 Implantable Cardioverter Defibrillators (ICDs), Visia AF MRI. Labeled as the ... Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibri... Class I Medtronic Inc., Cardiac Rhythm and Heart Failur...
Dec 19, 2017 Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Viva. Labeled as ... Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibri... Class I Medtronic Inc., Cardiac Rhythm and Heart Failur...
Dec 19, 2017 Implantable Cardioverter Defibrillators (ICDs), Visia AF. Labeled as: a. V... Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibri... Class I Medtronic Inc., Cardiac Rhythm and Heart Failur...
Dec 19, 2017 Implantable Cardioverter Defibrillators (ICDs), Evera. Labeled as the followi... Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibri... Class I Medtronic Inc., Cardiac Rhythm and Heart Failur...
Dec 19, 2017 Implantable Cardioverter Defibrillators (ICDs), Evera MRI. Labeled as the fo... Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibri... Class I Medtronic Inc., Cardiac Rhythm and Heart Failur...
Dec 15, 2017 Confidence Plus Kit Spinal Cement System, Product Codes: 283910000 (GTIN: (01... Certain lots of the spinal cement may contain incorrect amounts of contrast medium so that the pr... Class II DePuy Spine, Inc.
Dec 14, 2017 DermaPro Waterproof Silicone Tape, SNS57232 The recalling firm received a customer complaint stating the tape was difficult to peel off the r... Class II Safe N Simple, LLC
Dec 11, 2017 Synvisc-One ¿ (hylan G-F 20), 6mL delivered from a 10mL syringe Product Us... Contamination with Methylbacterium thiocyanatum Class II Sanofi Genzyme

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.