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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

1,550 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,550 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 1,550 FDA device recalls in 2012.

Clear
DateProductReasonClassFirm
May 22, 2012 CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5, Part Number 6607013.... The recall was initiated because Beckman Coulter has determined that the specimen and prepared sa... Class II Beckman Coulter Inc.
May 22, 2012 BD GeneOhm MRSA ACP Assay Catalog #441637, box 48 tests labeled in part***Gen... Leakage in Cepheid SmartCycler reaction tubes. Class II Becton Dickinson & Co.
May 22, 2012 Alere Triage CardioProfiler Panel PN 97100CP Used for the quantitative det... Certain lots of the affected products may have significantly decreased precision relative to the ... Class I Alere San Diego, Inc.
May 21, 2012 Olympic Cool-Cap System is intended to provide treatment for neonatal hypoxi... Olympic Cool-Cap Cooling Module's power supply failed during treatment. The power supply failure... Class II Natus Medical Incorporated
May 21, 2012 Formula Shaver Handpiece (with buttons); Formula 180 Shaver Handpiece (with ... Stryker Endoscopy determined that there may not have been adequate determination of required rout... Class II Stryker Endoscopy
May 21, 2012 VITROS 5,1 FS System Software For use in the in-vitro quantitative, semi ... software automatically switches the lot when a vancomycin (VANC) or valproic acid (VALP) reagent ... Class II Ortho-Clinical Diagnostics
May 21, 2012 Philips Multi Diagnost Eleva II with swivel cable Product Codes; 708032, 70... MultiDiagnost Eleva X--Ray system may have damage to System Cables from repeated movement Class II Philips Healthcare Inc.
May 21, 2012 VITROS 4600 Chemistry System Software For use in the in-vitro quantitativ... software automatically switches the lot when a vancomycin (VANC) or valproic acid (VALP) reagent ... Class II Ortho-Clinical Diagnostics
May 21, 2012 VITROS 5600 Integrated System Software For use in the in-vitro quantitati... software automatically switches the lot when a vancomycin (VANC) or valproic acid (VALP) reagent ... Class II Ortho-Clinical Diagnostics
May 17, 2012 Go Bed II+ Model FL 28 Ex Beds are intended for medical purposes in both ... An adverse trend of scale and bed exit service reports/complaints were detected for the GoBed+, G... Class II Stryker Medical Division of Stryker Corporation
May 17, 2012 Go Bed II+ Model FL28C Beds are intended for medical purposes in both gen... An adverse trend of scale and bed exit service reports/complaints were detected for the GoBed+, G... Class II Stryker Medical Division of Stryker Corporation
May 17, 2012 Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in ... An adverse trend of scale and bed exit service reports/complaints were detected for the GoBed+, G... Class II Stryker Medical Division of Stryker Corporation
May 17, 2012 Stryker Rose Bed Model (FL14E) Beds are intended for medical purposes in ... An adverse trend of scale and bed exit service reports/complaints were detected for the GoBed+, G... Class II Stryker Medical Division of Stryker Corporation
May 17, 2012 GoBed+ . Model FL20E Beds are intended for medical purposes in both genera... An adverse trend of scale and bed exit service reports/complaints were detected for the GoBed+, G... Class II Stryker Medical Division of Stryker Corporation
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 15, 2012 PTS Panels Creatinine test strips. PTS Panels Creatinine Test Strips are i... During a routine product investigation, a creatinine sample with a value less than 1.0 mg/dl was ... Class II Polymer Technology Systems, Inc.
May 14, 2012 Hartmann Sterilux Ref 56910000 Sterile Premium gauze sponge 4"x4" 12-ply ... Micro holes were detected in the laminate of the sterile barrier system of sterilized Hartmann Ec... Class II Hartmann USA, Inc
May 14, 2012 Hartmann Econolux Ref 416 105 Sterile Gauze sponge 4"x4" 12-ply 24 boxes/... Micro holes were detected in the laminate of the sterile barrier system of sterilized Hartmann Ec... Class II Hartmann USA, 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 12, 2012 Bigliani/Flatow The Complete Shoulder Solution Trabecular Metal Glenoid Instr... Bigliani/Flatow The Complete Shoulder Solution Trabecular Metal Glenoid Instrument Drill with Sto... Class II Zimmer, Inc.
May 12, 2012 BriteField illuminated Suction Device; Model numbers 8Fr, 10Fr and 12Fr, Kit... Invuity is notifying customers to return all obsolete BriteField Illuminated Suction Devices from... Class II Invuity, Inc.
May 11, 2012 ACUSON SC2000 volume imaging ultrasound systems at software versions VA16C, V... In some cases, the system is unable to capture a clip or image during a routine scan. Class II Siemens Medical Solutions USA, Inc.
May 11, 2012 Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HF7P. ... The device is being recalled because the firm received multiple complaints related to passage of ... Class II Edwards Lifesciences, LLC
May 11, 2012 Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 141F7. F... The device is being recalled because the firm received multiple complaints related to passage of ... Class II Edwards Lifesciences, LLC
May 11, 2012 Philips Easy Diagnost Product Usage: Stationary Fluoroscopic system If a lead ruler is not positioned in the same plane as the anatomical image detail to be measured... Class II Philips Healthcare Inc.
May 11, 2012 Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 151F7. F... The device is being recalled because the firm received multiple complaints related to passage of ... Class II Edwards Lifesciences, LLC
May 11, 2012 Vygon VY(TM)Flush Heparin Lock Flush Syringes, 10 Units per mL, 5mL in a 10mL... Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringe... Class II Vygon Corporation
May 11, 2012 Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 141HF7P. ... The device is being recalled because the firm received multiple complaints related to passage of ... Class II Edwards Lifesciences, LLC
May 11, 2012 Churchill Medical Systems, Inc. VAD ACCESS TRAY Kit Prefilled syringes inc... Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringe... Class II Vygon Corporation

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.