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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

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

3,419 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,419 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 3,419 FDA device recalls in MA.

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DateProductReasonClassFirm
Aug 9, 2012 Omnilife Science Apex Knee System Modular Tibia Augment, Size 4 x 4mm Ref: K... The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compro... Class II Omni Life Science
Aug 9, 2012 Omnilife Science Apex Knee System Modular Tibia Augment, Size 5 x 4mm Ref: K... The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compro... Class II Omni Life Science
Aug 7, 2012 ADVIA Centaur FSH Assay: ADVIA Centaur Calibrator B US: Calibrator B 00652... ADVIA Centaur Prolactin Assay and FSH, Calibrator B fails the analytical sensitivity stated in t... Class III Siemens Healthcare Diagnostics, Inc
Aug 7, 2012 ADVIA Centaur Prolactin Assay: ADVIA Centaur Calibrator B Catalog Number. P... ADVIA Centaur Prolactin Assay and FSH, Calibrator B fails the analytical sensitivity stated in t... Class III Siemens Healthcare Diagnostics, Inc
Aug 3, 2012 Instrumentation Laboratory ACL TOP 500 CTS PN 0000280040 ACL TOP is a b... Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low Class II Instrumentation Laboratory Co.
Aug 3, 2012 Medstream 81" (206 cm) 20 Drop Standard bore Universal Administration Set wi... Devices leaking at the Y-site Class II Medical Specialties Distributors, Inc.
Aug 3, 2012 Instrumentation Laboratory ACL TOP 700 PN 0000280010 ACL TOP is a bench t... Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low Class II Instrumentation Laboratory Co.
Aug 3, 2012 Instrumentation Laboratory ACL TOP 700 LAS PN 0000280030 ACL TOP is a b... Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low Class II Instrumentation Laboratory Co.
Aug 3, 2012 Instrumentation Laboratory ACL TOP CTS PN 0000280020 ACL TOP is a bench ... Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low Class II Instrumentation Laboratory Co.
Aug 3, 2012 Instrumentation Laboratory ACL TOP 700 CTS PN 0000280050 ACL TOP is a b... Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low Class II Instrumentation Laboratory Co.
Aug 3, 2012 Instrumentation Laboratory ACL TOP (Base) PN 0000280000 ACL TOP is a benc... Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low Class II Instrumentation Laboratory Co.
Jul 25, 2012 Philips Essenta DR, X-Ray System, Diagnostic, general-purpose Model: 712070.... Essenta DR C-Arm may fall Class II Philips Healthcare Inc.
Jul 25, 2012 Siemens ADVIA Centaur Multi-Diluent 1 - Used for automated dilutions for the ... Decrease in onboard dilution recovery when using Multi-Diluent 1 that has been stored on board th... Class II Siemens Healthcare Diagnostics, Inc
Jul 24, 2012 DePuy Spine EXPEDIUM Offset Torque Wrench Product Code 2797-29-510 The de... A component within the handle of the Expedium Offset Torque Wrench is prematurely wearing, potent... Class II DePuy Spine, Inc.
Jul 17, 2012 Conformis iTotal CR-Cruciate Retaining Knee Replacement System Model Number... Addendum Labeling iTotal CR Surgical Technique with Detailed Instructions of Total CR Poly Insert... Class II Conformis Inc
Jul 17, 2012 Siemens ADVIA Centaur¿ Syphilis (SYPH) Assay , 200 ReadyPack Reference Num... Syphilis Assay Interference with HBsAg Assay Class II Siemens Healthcare Diagnostics, Inc
Jul 14, 2012 Smith & Nephew Dyonics Electroblade Resector, 4.5mm Full Radius Blade, BONECU... Devices labeled with an expiry period of 48 months instead of 36 months; an additional 12 months ... Class II Smith & Nephew, Inc. Endoscopy Division
Jul 14, 2012 Smith & Nephew 5.5 mm Dyonics Bonecutter ,Electroblade Full Radius Part Nu... Device labeled with an expiry period of 48 months instead of 36 months; an additional 12 months f... Class II Smith & Nephew, Inc. Endoscopy Division
Jul 11, 2012 Straumann Narrow CrossFit (NC) Screw for CARES Abutment ZrO2. Endosseous dent... Incorrect Screw (RC) included with NC CARES Abutment Set was not a Narrow CrossFit (NC) Screw for... Class II Straumann USA, LLC
Jul 11, 2012 Philips Easy Diagnost Classic-Stationary x-ray system Catalog Numbers: 70642... Inclination switch in the stand may have been mounted incorrectly, as a result, the switch could ... Class II Philips Healthcare Inc.
Jul 11, 2012 Philips MultiDiagnost Eleva with Flat Detector (MD Eleva FD)Model: 708034 ... When doing a 3 Dimensional Rotational Angiography (3DRA) the 3D reconstruction does not always st... Class II Philips Healthcare Inc.
Jul 11, 2012 Medtronic O-arm¿ Imaging System. Product Numbers: BI-700-00027-100, BI-700-0... A fault in a high voltage relay in the 0-arm¿ Imaging System might cause the relay to overheat an... Class II Medtronic Navigation, Inc.
Jul 3, 2012 Smith & Nephew 5.5 mm TWINFIX Ultra Ti Suture Anchor with two #2 ULTRABRAID s... Distal part of the anchor may break on insertion into bone during surgery Class II Smith & Nephew, Inc. Endoscopy Division
Jul 3, 2012 Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with two #2 sutures (COBRAID-bl... Distal part of the anchor may break on insertion into bone during surgery Class II Smith & Nephew, Inc. Endoscopy Division
Jul 3, 2012 Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with two #2 sutures(white, COBR... Distal part of the anchor may break on insertion into bone during surgery Class II Smith & Nephew, Inc. Endoscopy Division
Jul 3, 2012 Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with three #2 sutures (white, C... Distal part of the anchor may break on insertion into bone during surgery Class II Smith & Nephew, Inc. Endoscopy Division
Jun 27, 2012 Perkin Elmer Genetic Screening Processor (GSP) Product Code: 2021-0010 Pr... Contamination from GSP Shaker unit results in decreased signal activity of assay measurements for... Class II Perkinelmer
Jun 27, 2012 Smiths Medical HOTLINE 3 Blood and Fluid Warmer, Reorder Numbers: HL-390 ... HOTLINE 3 Blood and Fluid Warmer( Reorder No. HL-390 ) disposable is not correctly installed , t... Class II Smiths Medical ASD, Inc.
Jun 20, 2012 Philips HeartStart MRx monitor/defibrillators Models: M3535A, M3536A, M3536M... HeartStart MRx Unexpected Pads/Paddles ECG Failure Class II Philips Healthcare Inc.
Jun 20, 2012 Philips HeartStart MRx monitor/defibrillators Models: M3535A and M3536A, M35... Therapy Cable Connection wear may lead to a malfunction in detection of defibrillation pads/paddl... Class II Philips Healthcare Inc.
Jun 20, 2012 Philips HeartStart MRx M3536A Defibrillator/Monitor with Software R.03.03 ... Defibrillator/monitor cannot analyze an ECG report during acquisition of 12 lead ECG Class II Philips Healthcare Inc.
Jun 19, 2012 EOS X-ray Medical Diagnostic , X-ray Equipment System Digital Radiography ... It was discovered of several generator failures of the EOS System due to failure of its anode con... Class II Eos Imaging Inc
Jun 14, 2012 Philips Xcelera Connect, Software R2.1 L 1 SP2, an interface engine for data... Xcelera Connect R2.1 L 1 SP2 , incomplete information arriving from unformatted reports interface Class II Philips Healthcare Inc.
Jun 13, 2012 seprafilm¿ Single Site ADHESION BARRIER Re-order Number: 6641-01 Product ... Sterility of product may be compromised due to packaging defect Class II Genzyme Corporation
Jun 13, 2012 seprafilm¿ Procedure Pack ADHESION BARRIER Re-order Number: 5086-02 Pro... Sterility of product may be compromised due to packaging defect Class II Genzyme Corporation
Jun 6, 2012 Spacelabs Ultraview DM3 Monitor Model Number: 91330-NT The Ultraview DM3 ... Unit fails to power up, resulting in an equipment alarm Class II Zoe Medical Incorporated
May 29, 2012 MULTIGENT Acetaminophen for use with Architect/Aeroset Cat. No. 2K99-20. ... Discoloration of the acetaminophen enzyme reagent (R1), generates a high calibration factor and e... Class II Sekisui Diagnostics Llc
May 22, 2012 Philips Digital Diagnost Software, software release 2.0.2 and 2.0.2SP1 includ... With Digital Diagnost (DIDI) R 2.0.2 a mirrored "R in a circle" is burnt into the image (if mirro... Class II Philips Healthcare Inc.
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 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 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 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 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 9, 2012 Invue Solid Driver, Tipped, AO. Part Number: 11-70083. Allows the user ... The nipple of the tipped driver broke off when surgeons were attempting to insert the screw. Class II SpineFrontier, Inc.
May 5, 2012 Robotic hand accessory to InMotion Arm, rehabilitation robot. Unsupervised patient could potentially mis-use the device and remove or rotate a protective cover... Class II Interactive Motion Technologies, Inc.
May 4, 2012 Depuy Spine Side Fire Needles 13G X 4IN Side-Fire Needle, part of the Confide... Additional Instructions for Use and Surgical Technique for the Confidence Needle due to reports o... Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
May 4, 2012 Depuy Spine Side Fire Needles 11G X 4IN, part of the Confidence Spinal Cement... Additional Instructions for Use and Surgical Technique for the Confidence Needle due to reports o... Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
May 4, 2012 Depuy Spine Side Fire Needles 13G X 6IN, part of the Confidence Spinal Cemen... Additional Instructions for Use and Surgical Technique for the Confidence Needle due to reports o... Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
May 4, 2012 Depuy Spine Side Fire Needles 11G X 6IN Side-Fire Needle, part of the Confide... Additional Instructions for Use and Surgical Technique for the Confidence Needle due to reports ... Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Mar 29, 2012 Fresenius NaturaLyte Liquid Acid Concentrate Product Codes: 08-0231-4, 08-... Risk of Alkalosis with acetate containing dialysis acid concentrates Class I Fresenius Medical Care Holdings, Inc.

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.