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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

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.

Clear
DateProductReasonClassFirm
Mar 13, 2013 ADVIA Centaur Vitamin D Calibrator 6-pack; Reference Number:10630911. For ... Negative bias in patient samples for Vitamin D Class II Siemens Healthcare Diagnostics, Inc
Mar 13, 2013 ADVIA Centaur Vitamin D Calibrator 2-pack; Reference Number:10493589. For ... Negative bias in patient samples for Vitamin D Class II Siemens Healthcare Diagnostics, Inc
Mar 13, 2013 ADVIA Centaur Vitamin D Assay (500 tests); Reference Number:10631021. For ... Negative bias in patient samples for Vitamin D Class II Siemens Healthcare Diagnostics, Inc
Mar 13, 2013 ADVIA Centaur Vitamin D Assay (100 tests); Reference Number: 10491994. For... Negative bias in patient samples for Vitamin D Class II Siemens Healthcare Diagnostics, Inc
Mar 11, 2013 PrimaConnex Tapered Implant TC, SD Internal Connection 3.5 x 10mm Catalog N... Mislabeled: Cover screw that was in the package was a WD cover screw and not a SD cover screw as ... Class II Keystone Dental Inc
Mar 5, 2013 Philips IntellVue Info Center iX 866023; PIIC iX Upgrade 866024; IntellVue Se... If a customer creates customized trend scales in the trend review tile and the iX or primary serv... Class II Philips Healthcare Inc.
Feb 28, 2013 Allen Traction Boot, Modular, OT 1000 Traction Device Boot Assembly, Fractur... Some units may have been assembled incorrectly which could result in the boot breaking free from ... Class II Allen Medical Systems, Inc.
Feb 26, 2013 Neurotherm Curved Radiofrequency (RF) cannnula 10 cm 18 gauge, 10 mm activ... Straight needle labeled as a curved needle Class II Neurotherm, Inc.
Feb 26, 2013 CLINITEK Status+ Analyzer (portable urine chemistry analyzer). Catalog number... Device with Sample Interference Notes (SIN) enabled not cleared for US marketing. Class III Siemens Healthcare Diagnostics Inc
Feb 25, 2013 Nova StatStrip Xpress Glu-Test Strips (Glucose test strips) Catalog # 51493 ... Glucose test strips reports no result message when tested Class II Nova Biomedical Corporation
Feb 25, 2013 Nova StatStrip Xpress Glu-Test Strips (Glucose test strips) Catalog # 42214 Glucose test strips reports no result message when tested Class II Nova Biomedical Corporation
Jan 31, 2013 Medtronic O-arm Imaging System Product Usage: image-intensified fluorosco... Potential failure of the braking system that controls the O-arm Imaging System gantry movement in... Class II Medtronic Navigation, Inc.
Jan 28, 2013 Philips HeartStart XL+ Defibrillator/Monitor Model number: 861290 The He... Philips HeartStart XL+ Defibrillator/Monitor may become locked out of clinical use Class II Philips Healthcare Inc.
Jan 16, 2013 Philips Diagnost Stationary Radiographic System Models: 712020, 712022, 71... Installation Acceptance Test Document (IATD) non compliant with regulations. Records shows table ... Class II Philips Healthcare Inc.
Jan 16, 2013 Phillips Easy Diagnost Eleva DRF. Model Number: 706034 Product Usage: Uni... The mirror icon on the bottom of each image could be misinterpreted as a RIGHT lead marker for si... Class II Philips Healthcare Inc.
Jan 16, 2013 Philips BuckyDiagnost Radiographic, a Diagnostic X-ray system. Catalog Nu... An inspection shows several IATDs (Installation Acceptance Test could not be located or different... Class II Philips Healthcare Inc.
Jan 16, 2013 Philips Diagnost Stationary Radiographic System Models: 712020, 712022, 71... Installation Acceptance Test Document (IATD) non compliant with regulations IATDs (Installation A... Class II Philips Healthcare Inc.
Jan 16, 2013 Philips BuckyDiagnost Radiographic. Catalog Numbers: 704031, 704032... An inspection of IATD (Installation Acceptance Test Document)IA SID (Source Image Distance) recor... Class II Philips Healthcare Inc.
Jan 15, 2013 DePuy CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT Catalog Number:283905000. D... Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck Class II DePuy Spine, Inc.
Jan 15, 2013 DePuy CONFIDENCE SPINAL CEMENT SYSTEM 7CC KIT Catalog Number: 283907000. ... Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck Class II DePuy Spine, Inc.
Jan 15, 2013 DePuy CONFIDENCE SPINAL CEMENT SYSTEM KIT Catalog Number: 283913000. Del... Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck Class II DePuy Spine, Inc.
Jan 15, 2013 DePuy CONFIDENCE SPINAL CEMENT SYSTEM 11C Plus KIT Catalog Number: 283910000... Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck Class II DePuy Spine, Inc.
Jan 14, 2013 P10 Tobii battery box (product number 510410) Product Usage - Battery pack... Tobii ATI customers P10 external battery pack, which contains sealed lead-acid batteries, malfunc... Class II Tobii Assistive Technology, Inc.
Jan 14, 2013 Philips Healthcare SureSigns VS2+ Model 863278 SureSigns VS2+ NBP and SpO2 ... VS2+ screen may lock up and stop monitoring during patient use Class II Philips Healthcare Inc.
Jan 11, 2013 NEUROPATH 6Fx90 GUIDING CATH ST Product Code: GST60900000 Intended for us... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 6Fx100 GUIDING CATH MP Product Code: GMD61000000 Intended for u... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 6Fx100 GUIDING CATH ST Product Code: GST61000000 Intended for u... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 6Fx100 GUIDING CATH S2 Product Code: GSM61000000 Intended for ... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 5Fx100 GUIDING CATH HH Product Code: GMC51000000 Intended for u... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 6Fx100 GUIDING CATH MC Product Code: GCB61000000 Intended for u... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 6Fx100 GUIDING CATH MPD Product Code: GMD60900000 Intended for ... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 5Fx90 GUIDING CATH ST Product Code: GST50900000 Intended for us... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 6Fx90 GUIDING CATH MPC Product Code: GMC60900000 Intended for u... Sterility of device may be compromised due to lack of packaging integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 5Fx100 GUIDING CATH S2 Product Code: GSM51000000 Intended for u... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 5Fx90 GUIDING CATH HH Product Code: GHH50900000 Intended for us... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 6Fx100 GUIDING CATH HH Product Code: GHH61000000 Intended for u... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 5Fx90 GUIDING CATH S2 Product Code: GSM50900000 Intended for us... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 5Fx100 GUIDING CATH ST Product Code: GST51000000 Intended for u... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 5Fx90 GUIDING CATH MPC Product Code: GMC50900000 Intended for u... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 5Fx90 GUIDING CATH MCV Product Code: GCB50900000 Intended for u... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 6Fx100 GUIDING CATH MP Product Code: GMC61000000 Intended for u... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 5Fx100 GUIDING CATH MP Product Code:GMD51000000 Intended for us... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 5Fx90 GUIDING CATH MPD Product Code: GMD50900000 Intended for u... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 5Fx100 GUIDING CATH HH Product Code: GHH51000000 Intended for u... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 6Fx90 GUIDING CATH MCV Product Code: GCB60900000 Intended for u... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 6Fx90 GUIDING CATH HH Product Code: GHH60900000 Intended for us... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 6Fx90 GUIDING CATH S2 Product Code: GSM60900000 Intended for us... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 5Fx100 GUIDING CATH MC Product Code: GCB51000000 Intended for u... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 8, 2013 SeriScaffold Surgical Scaffold Product Number: SCF10X25AGEN. Surgical mes... Product is dual packaged in an inner and outer pouch, the outer pouch seal may be compromised and... Class II Allergen Medical
Dec 20, 2012 Medisystems 15 Gauge x 3/5 inch Buttonhole Needle Set Product Code: BH-2035P... A total of 5 (ea) single needle pouches are mislabeled as 15 Ga x1" instead of 15 Ga x 3/5". Class II Medisystems a NX Stage Company

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.