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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

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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

2,447 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,447 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 2,447 FDA device recalls.

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DateProductReasonClassFirm
May 16, 2012 LUSTER HIP SZ 1 Packaging: The product was packaged within inner and outer... DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femora... Class II DePuy Orthopaedics, Inc.
May 14, 2012 Alere Triage Tox+MTD Drug Screen, PN 94400 Product Usage: The Alere Triag... A recall was initiated because Alere San Diego has confirmed that the Triage TOX Drug Screen may ... Class II Alere San Diego, Inc.
May 9, 2012 Covidien ROTICULATOR 30-V3 Single Use Stapler REF# 017619 The RETICULA T... Potential for the sterility barrier to be compromised. Class II Covidien LP
May 9, 2012 Covidien ROTICULATOR 30-4.8 Single Use Stapler REF# 017617 The RETICULA ... Potential for the sterility barrier to be compromised. Class II Covidien LP
May 9, 2012 Covidien ROTICULATOR 30-3.5 Single Use Stapler REF# 017615 The RETICULA ... Potential for the sterility barrier to be compromised. Class II Covidien LP
May 9, 2012 Covidien ROTICULATOR 55-3.5 Single Use Stapler REF# 017612 The RETICULA T... Potential for the sterility barrier to be compromised. Class II Covidien LP
May 9, 2012 Covidien ROTICULATOR 55-4.8 Single Use Stapler REF# 017614 The RETICULA ... Potential for the sterility barrier to be compromised. Class II Covidien LP
Apr 24, 2012 The brand name of the device is Damon 3MX Bicuspid Bracket, an orthodontic br... The firm initiated the recall as a result of a misidentification of the brackets. Damon 3MX Bicus... Class III Ormco/Sybronendo
Apr 17, 2012 High Pressure Stopcock (3-Way, Luer Lock, Off). Product Usage: For IV. The firm initiated the recall due to a molding defect in a high pressure stopcock where a small ... Class II ICU Medical, Inc.
Apr 17, 2012 Cardiac Catheterization Waste Management System w/1000mL Waste Bag, 2 Fluid A... The firm initiated the recall due to a molding defect in a high pressure stopcock where a small ... Class II ICU Medical, Inc.
Apr 17, 2012 94" (239cm) 20 Drop Admin Set w/High Pressure 4-Way (300 psi) Stopcock, Rota... The firm initiated the recall due to a molding defect in a high pressure stopcock where a small ... Class II ICU Medical, Inc.
Apr 17, 2012 Flush Kit w 3 Way Off Stopcock Product Usage: Flush Kit The firm initiated the recall due to a molding defect in a high pressure stopcock where a small ... Class II ICU Medical, Inc.
Apr 12, 2012 Gram Crystal Violet 250 mL, catalog #212525, in cartons of 4 bottles. Gra... Potential for increase level of artifacts to appear as large, spherical and easy to distinguish o... Class II Becton Dickinson & Co.
Apr 12, 2012 BD Gram Stain Kit, containing 1- 250 mL bottle of Gram Crystal Violet, and a... Potential for increase level of artifacts to appear as large, spherical and easy to distinguish o... Class II Becton Dickinson & Co.
Apr 3, 2012 Unicel DxH 800 Coulter Cellular Analysis System, Part Number 629029. The U... Beckman Coulter is recalling the UniCel DxH 800 Coulter Cellular Analysis System because the NRBC... Class II Beckman Coulter Inc.
Mar 14, 2012 Ultrafill DBM labeled in part: TISSUENET Sterilized by T10^6 Description: Ult... Surgical Tissue Network Inc., DBA TissueNet Inc. recalled their UltraFill DBM Putty-Porcine (1 cc... Class II Surgical Tissue Network, Inc.
Mar 14, 2012 UltraFill DBM labeled in part: TISSUENET Sterilized by T10^6 Description: ... Surgical Tissue Network Inc., DBA TissueNet Inc. recalled their UltraFill DBM Putty-Porcine (1 cc... Class II Surgical Tissue Network, Inc.
Mar 14, 2012 UltraFill DBM labeled in part: TISSUENET Sterilized by T10^6 Description: U... Surgical Tissue Network Inc., DBA TissueNet Inc. recalled their UltraFill DBM Putty-Porcine (1 cc... Class II Surgical Tissue Network, Inc.
Mar 7, 2012 Pinnacle Hip Solutions ALTRX Polyethylene Acetabular Liner, Ref 1221-36-452 ... DePuy Orthopaedics, Inc. (DePuy) is issuing a voluntary recall of one lot of the AltrX" liner be... Class II DePuy Orthopaedics, Inc.
Feb 21, 2012 The brand name of the device is AlgiNot, a dental impression material. Produ... The firm recalled the product because it may cure harder than expected within the shelf life, wh... Class II Kerr Corporation
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.
Jan 26, 2012 Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Pr... Stryker has become aware that there exists a potential for breach of the sterile barrier of packa... Class II Stryker Howmedica Osteonics Corp.
Jan 23, 2012 VMX, VMX Plus Mobile Radiographic Unit with the following models: 45296139;... GE Healthcare has become aware of an issue associated with the base casting for the articulated a... Class II GE Healthcare, LLC
Dec 22, 2011 Infinity¿ sampling device, Cytology Brush, United States Endoscopy Group, Inc... US Endoscopy received five complaints which noted difficulty in deploying the cytology brush thro... Class II US Endoscopy Group Inc
Nov 30, 2011 Brand Name: RX Accunet Embolic Protection System Common Name: RX Accunet EPS... The recall was initiated because Abbot Vascular has discovered that the identified lots of the RX... Class II Abbott Vascular
Sep 23, 2011 Product is labeled in part: "***OPTETRAK RBK***TIBIAL TRAY***FINNED, CEMENT... Exactech, Inc. Gainesville, FL is recalling their Optetrak Cemented Trapezoid Tibial Tray, Size 1... Class II Exactech, Inc.
Sep 20, 2011 Pentron Clinical Metrex Research; Pinnacle Cure Sleeve, a protective barrier ... The firm initiated the recall due to a labeling error. The boxes labeled as Pinnacle Cure Sleeve ... Class II Metrex Research, LLC.
Apr 13, 2011 IO Fix IntraOsseous Fixation System; Extremity Medical. www.extremitymedical... Product Event Reports revealed that lag screw passes through washer (e.g. X-Post) intra-operatively. Class II Extremity Medical LLC
Dec 31, 2010 ULTRA Fabric Reinforced Surgical Gown, X-Large, Sterile, Test File. The Ki... The impacted product was not intended for commercial distribution to end users. Class III Kimberly-Clark Corporation
Oct 10, 2010 . 00789503601 VerSys Femoral Head Provisional 36mm -3.5 00789503602 VerSys F... Surgical technique instructions for the Versys and Slotted Provisional Femoral Heads have been en... Class II Zimmer, Inc.
Oct 10, 2010 00789502601 VerSys Femoral Head Provisional 26mm -3.5 00789502602 VerSys Fem... Surgical technique instructions for the Versys and Slotted Provisional Femoral Heads have been en... Class II Zimmer, Inc.
Oct 10, 2010 Product 100789502202 VerSys Femoral Head Provisional 22mm +0 00789502203 Ver... Surgical technique instructions for the Versys and Slotted Provisional Femoral Heads have been en... Class II Zimmer, Inc.
Oct 10, 2010 00789503201 VerSys Femoral Head Provisional 32mm -3.5 00789503202 VerSys Fem... Surgical technique instructions for the Versys and Slotted Provisional Femoral Heads have been en... Class II Zimmer, Inc.
Oct 10, 2010 00780302601 MIS 12/14 Slotted Femoral Head Provisional -3.5X26 00780302602 M... Surgical technique instructions for the Versys and Slotted Provisional Femoral Heads have been en... Class II Zimmer, Inc.
Oct 10, 2010 00780302801 MIS 12/14 Slotted Femoral Head Provisional -3.5X28 00780302802 M... Surgical technique instructions for the Versys and Slotted Provisional Femoral Heads have been en... Class II Zimmer, Inc.
Oct 10, 2010 . 00789502801 VerSys Femoral Head Provisional 28mm -3.5 00789502802 VerSys F... Surgical technique instructions for the Versys and Slotted Provisional Femoral Heads have been en... Class II Zimmer, Inc.
Oct 10, 2010 00780303601 MIS 12/14 Slotted Femoral Head Provisional -3.5X36 00780303602 M... Surgical technique instructions for the Versys and Slotted Provisional Femoral Heads have been en... Class II Zimmer, Inc.
Oct 10, 2010 00780302201 MIS 12/14 Slotted Femoral Head Provisional -2X22 00780302202 MIS... Surgical technique instructions for the Versys and Slotted Provisional Femoral Heads have been en... Class II Zimmer, Inc.
Oct 10, 2010 00780304001 MIS 12/14 Slotted Femoral Head Provisional -3.5X36 00780304002 M... Surgical technique instructions for the Versys and Slotted Provisional Femoral Heads have been en... Class II Zimmer, Inc.
Oct 10, 2010 00780303201 MIS 12/14 Slotted Femoral Head Provisional -3.5X32 00780303202 M... Surgical technique instructions for the Versys and Slotted Provisional Femoral Heads have been en... Class II Zimmer, Inc.
Oct 10, 2010 00789504001 VerSys Femoral Head Provisional 40mm -3.5 00789504002 VerSys Fem... Surgical technique instructions for the Versys and Slotted Provisional Femoral Heads have been en... Class II Zimmer, Inc.
Feb 17, 2010 A mobile, electro-hydraulically operated, fluoroscopic/C-Arm compatible gener... Customers may be storing objects on the base and/or around the column of the surgical table. Thi... Class II Steris Corporation
Dec 29, 2009 Spiegelberg Brain Pressure Monitoring System Probe 3PN, REF: SNDI3.1.531FV53... In the vast majority of products specified, a shrinkage of the air chamber during sterilization h... Class II Spiegelberg Gmbh & Co. KG
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.
Sep 17, 2009 MicroCool Breathable Impervious Gown with Secure Fit Surgical, (Large and X-L... Complaints were received of gowns pilling or balling, linting and abrades, blood strikethrough an... Class II Kimberly-Clark Corporation
Sep 17, 2009 MicroCool Breathable Impervious Surgical Gown, (Large and X-Large), Sterile, ... Complaints were received of gowns pilling or balling, linting and abrades, blood strikethrough an... Class II Kimberly-Clark Corporation
Apr 6, 2009 Harmonie software versions 5.1 uo to 6.2e : Harmonie-E Long Term Monitoring ... The firm is initiating this recall because the implied or stated indications in their labeling as... Class II Stellate Systems

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.