Vehicle Safety
Recalls Search 320,000+ NHTSA safety recalls Complaints 2.1M+ consumer safety complaints TSBs 4.7M technical service bulletins VIN Lookup Decode any vehicle VIN instantly OBD Codes 12,000+ diagnostic trouble codes Fuel Economy EPA MPG data for all vehicles Safety Ratings 11,700+ NHTSA crash test ratings Investigations 5,300+ NHTSA defect investigations Statistics Recall trends & safety analysis
Consumer Safety
Product Safety 9,700+ CPSC product recalls Food Safety 28,600+ FDA food recalls Pet Safety 1.3M FDA animal adverse events Drug Safety 17,500+ FDA drug recalls Device Safety 38,400+ FDA device recalls Workplace Safety 102,900+ OSHA injury reports Brand History Cross-category recall lookup by company
Infrastructure
Bridge Safety 624,000 bridge inspections Aviation Safety 30,000+ NTSB aviation events Dam Safety 92,600 dam safety records Water Safety 433,000+ public water systems Railroad Safety 438,000+ rail crossings Pipeline Safety 8,800+ pipeline incidents State Safety Dashboards Safety grades for all 50 U.S. states ZIP Safety Report Check any 5-digit ZIP across 9 datasets
Public Health
Nursing Homes 14,700 CMS rated facilities Environmental 80,000+ hazardous sites & releases
Blog

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

Public Health

Nursing Homes14,700 CMS rated facilities Environmental80,000+ hazardous sites & releases BlogGuides, news & safety insights

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.

Clear
DateProductReasonClassFirm
Jun 1, 2012 Sysmex XE-2100C Automated Hematology System; an automated differential cell c... There is a variation of reticulocyte counts between XE Series (XE-2100, XE-5000) and XT-Series (X... Class II Sysmex America, Inc.
May 29, 2012 Advantage Workstation Volume Share 2 (versionAW4.4_04) with Volume Viewer 3 a... GE Healthcare has became aware of two issues with the Advantage Workstation. 1) A possible mis... Class II GE Healthcare, LLC
May 22, 2012 4.5mm TI Multiloc Screw Length 28MM-Sterile Expiration: 04/29/2012 REF 04.0... Two lots of 4.5mm multi-loc screws were recalled due to incorrect labeling of screw size. Class II Synthes USA HQ, Inc.
May 22, 2012 4.5mm TI Multiloc Screw Length 38MM-Sterile Expiration: 04/29/2012 REF 04.0... Two lots of 4.5mm multi-loc screws were recalled due to incorrect labeling of screw size. Class II Synthes USA HQ, Inc.
May 16, 2012 LUSTER HIP SZ 2 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 16, 2012 ULTIMA*LX STM,POL 10/12TAP/3M Packaging: The product was packaged within i... DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femora... Class II DePuy Orthopaedics, Inc.
May 16, 2012 LUSTER HIP SZ 8 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 16, 2012 ULTIMA*LX STM,POL 10/12TAP/SZ2 Packaging: The product was packaged within ... DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femora... Class II DePuy Orthopaedics, Inc.
May 16, 2012 ULTIMA*LX STM,POL 10/12TAP/SZ5 Packaging: The product was packaged within ... DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femora... Class II DePuy Orthopaedics, Inc.
May 16, 2012 LUSTER HIP SZ 4 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 16, 2012 ULTIMA*LX STM,POL 10/12TAP/SZ3 Packaging: The product was packaged within ... DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femora... Class II DePuy Orthopaedics, Inc.
May 16, 2012 LUSTER HIP SZ 7 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 16, 2012 LUSTER HIP SZ 6 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 16, 2012 ULTIMA*LX STM,POL 10/12TAP/SZ4 Packaging: The product was packaged within ... DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femora... Class II DePuy Orthopaedics, Inc.
May 16, 2012 Boston Scientific Profile Single-Use Pediatric Snare 27mm UPN Outer Box: M00... Difficulty in extending snare loop from the catheter Class II Boston Scientific Corporation
May 16, 2012 LUSTER HIP SZ 10 Packaging: The product was packaged within inner and oute... DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femora... Class II DePuy Orthopaedics, Inc.
May 16, 2012 Boston Scientific Profile Single-Use Pediatric Snare 11mm UPN Outer Box M005... Difficulty in extending snare loop from the catheter Class II Boston Scientific Corporation
May 16, 2012 ULTIMA*LX STM,POL 10/12TAP/1M Packaging: The product was packaged within i... DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femora... Class II DePuy Orthopaedics, Inc.
May 16, 2012 ULTIMA*LX STM,POL 10/12TAP/2M Packaging: The product was packaged within i... DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femora... Class II DePuy Orthopaedics, Inc.
May 16, 2012 ULTIMA*LX STM,POL 10/12TAP/4M Packaging: The product was packaged within i... DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femora... Class II DePuy Orthopaedics, Inc.
May 16, 2012 LUSTER HIP SZ 5 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 16, 2012 Boston Scientific Profile Single-Use Pediatric Snare 13mm UPN Outer Box: M00... Difficulty in extending snare loop from the catheter Class II Boston Scientific Corporation
May 16, 2012 ULTIMA*LX STM,POL 10/12TAP/SZ1 Packaging: The product was packaged within ... DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femora... Class II DePuy Orthopaedics, Inc.
May 16, 2012 LUSTER HIP SZ 9 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 16, 2012 LUSTER HIP SZ 3 Packaging: The product was packaged within inner and outer b... DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femora... Class II DePuy Orthopaedics, Inc.
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

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.