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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

3,010 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,010 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 3,010 FDA device recalls in 2019.

Clear
DateProductReasonClassFirm
Apr 9, 2019 ARCHITECT STAT High Sensitive Troponin-I Calibrators - Product Usage: The AR... Devices were delivered without the required dry ice. Class III Abbott Laboratories
Apr 9, 2019 ARCHITECT Intact PTH Calibrators - Product Usage: The ARCHITECT Intact PTH Ca... Devices were delivered without the required dry ice. Class III Abbott Laboratories
Apr 9, 2019 Pericardiocentesis Catheter Tray, RPN C-PCSY-850-LHSC-061096, Order # G10030 Affected products may have been manufactured with the catheter distal end hole too small Class II Cook Inc.
Apr 9, 2019 Thoracentesis Set, RPN C-THS-850, Order # G03286 Affected products may have been manufactured with the catheter distal end hole too small Class II Cook Inc.
Apr 8, 2019 Drill, cannulated, 4x150mm, AO, Item Number 502015403 An investigation identified that the products were possibly manufactured from a different materia... Class II Zimmer GmbH
Apr 8, 2019 Drill, 26mm stop, 1.4x81mm, AO, Item Number 502015124 An investigation identified that the products were possibly manufactured from a different materia... Class II Zimmer GmbH
Apr 8, 2019 Drill, 2.7x125mm, AO, Item Number 502015217 An investigation identified that the products were possibly manufactured from a different materia... Class II Zimmer GmbH
Apr 8, 2019 Drill, cannulated, 2.5x95mm, round shaft, Item Number ST502015620 An investigation identified that the products were possibly manufactured from a different materia... Class II Zimmer GmbH
Apr 8, 2019 CBS 4.0 countersink, cannulated, 30mm stop, AO, Item Number 503004353 An investigation identified that the products were possibly manufactured from a different materia... Class II Zimmer GmbH
Apr 8, 2019 AURIGA XL 4007 GENERAL - ZERO COST SYSTE UPN: FS4007GZ0 Product Usage: ... Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue... Class II Boston Scientific Corporation
Apr 8, 2019 Drill for 3.5mm screw, 2.5x125mm, stryker, Item Number 502015218 An investigation identified that the products were possibly manufactured from a different materia... Class II Zimmer GmbH
Apr 8, 2019 Drill for 2.7mm screw, 2x100mm, AO, Item Number 502015208 An investigation identified that the products were possibly manufactured from a different materia... Class II Zimmer GmbH
Apr 8, 2019 Drill for 2.7mm screw, 2x120mm, AO, Item Number ST502015212 An investigation identified that the products were possibly manufactured from a different materia... Class II Zimmer GmbH
Apr 8, 2019 V-TEK", standard-countersink, cannulated, round shaft, Item Number 28.66.110 An investigation identified that the products were possibly manufactured from a different materia... Class II Zimmer GmbH
Apr 8, 2019 V-TEK", IVP step drill 2-3.4x124mm, 16mm stop, AO, Item Number 502015636 An investigation identified that the products were possibly manufactured from a different materia... Class II Zimmer GmbH
Apr 8, 2019 Drill, 3.2x145mm, AO, Item Number 502015650 An investigation identified that the products were possibly manufactured from a different materia... Class II Zimmer GmbH
Apr 8, 2019 CBS high, countersink, cannulated, AO, Item Number ST503004542 An investigation identified that the products were possibly manufactured from a different materia... Class II Zimmer GmbH
Apr 8, 2019 CBS high, countersink, cannulated, AO, Item Number 503004542 An investigation identified that the products were possibly manufactured from a different materia... Class II Zimmer GmbH
Apr 8, 2019 Drill for 2.7mm screw, 2x100mm, AO, Item Number ST502015208 An investigation identified that the products were possibly manufactured from a different materia... Class II Zimmer GmbH
Apr 8, 2019 AURIGA 30 GENERAL - DEMO SYSTEM UPN: M0068S30GD0 Product Usage: The Au... Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue... Class II Boston Scientific Corporation
Apr 8, 2019 Drill for 2.7mm screw, 20mm stop, 2x105mm, Stryker, Item Number ST502015206 An investigation identified that the products were possibly manufactured from a different materia... Class II Zimmer GmbH
Apr 8, 2019 Drill, 26mm stop, 1.4x81mm, AO, Item Number 502015146 An investigation identified that the products were possibly manufactured from a different materia... Class II Zimmer GmbH
Apr 8, 2019 Drill, 2.7x125mm, AO , Item Number ST502015217 An investigation identified that the products were possibly manufactured from a different materia... Class II Zimmer GmbH
Apr 8, 2019 Drill for 2.7mm screw, 2x125mm, Stryker, Item Number 502015211 An investigation identified that the products were possibly manufactured from a different materia... Class II Zimmer GmbH
Apr 8, 2019 MaxiCan 4.5 countersink, cannulated, AO, Item Number 503004177 An investigation identified that the products were possibly manufactured from a different materia... Class II Zimmer GmbH
Apr 8, 2019 Drill, cannulated, 2.5x95mm, round shaft, Item Number 502015620 An investigation identified that the products were possibly manufactured from a different materia... Class II Zimmer GmbH
Apr 8, 2019 V-TEK", IVP step drill 2-3.4x124mm, 16mm stop, contra-angle, Item Number 5020... An investigation identified that the products were possibly manufactured from a different materia... Class II Zimmer GmbH
Apr 8, 2019 MediPress pneumatic compression system Full Arm (Medium)-Segmental Gradient, ... Product design change did not receive proper premarket clearance and lacks a 510 (k) Class II Compass Health Brands (Corporate Office)
Apr 8, 2019 Drill, cannulated, 4x120mm, AO, Item Number 502015402 An investigation identified that the products were possibly manufactured from a different materia... Class II Zimmer GmbH
Apr 8, 2019 V-TEK", standard-countersink, cannulated, AO, Item Number ST28.66.111 An investigation identified that the products were possibly manufactured from a different materia... Class II Zimmer GmbH
Apr 8, 2019 V-TEK", Micro-countersink, AO , Item Number ST28.66.113 An investigation identified that the products were possibly manufactured from a different materia... Class II Zimmer GmbH
Apr 8, 2019 Drill for 2.7mm screw, 23mm stop, 2x103mm, AO, Item Number 502015207 An investigation identified that the products were possibly manufactured from a different materia... Class II Zimmer GmbH
Apr 8, 2019 Drill for 2.7mm screw, 20mm stop, 2x105mm, Stryker, Item Number 502015206 An investigation identified that the products were possibly manufactured from a different materia... Class II Zimmer GmbH
Apr 8, 2019 Drill, 26mm stop, 1.9x94mm, Stryker, Item Number 502015130 An investigation identified that the products were possibly manufactured from a different materia... Class II Zimmer GmbH
Apr 8, 2019 Concorde Lift, Lordotic Expandable Interbody Device, spinal fusion implant 9x... A complaint trend was observed for post-operative loss of height and migration for Concorde Lift ... Class II DePuy Spine, Inc.
Apr 8, 2019 AURIGA XL 4007 GENERAL - DEMO SYSTEM UPN: M0068FS4007GD0 Product Usage: ... Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue... Class II Boston Scientific Corporation
Apr 8, 2019 VITROS 250AT Chemistry System, Product Code 1758143, (UDI # 10758750000036) ... Potential negative drift in Creatine Kinase (CK) results when used on the VITROS 250 and 350 Syst... Class II Ortho-Clinical Diagnostics
Apr 8, 2019 Drill, cannulated, 3x90mm, round shaft, Item Number ST502015630 An investigation identified that the products were possibly manufactured from a different materia... Class II Zimmer GmbH
Apr 8, 2019 CBS micro, countersink, cannulated, AO, Item Number ST503004541 An investigation identified that the products were possibly manufactured from a different materia... Class II Zimmer GmbH
Apr 8, 2019 MediPress pneumatic compression system Full Arm (Short)-Segmental Gradient, M... Product design change did not receive proper premarket clearance and lacks a 510 (k) Class II Compass Health Brands (Corporate Office)
Apr 8, 2019 Drill, cannulated, 4x150mm, AO, Item Number ST502015403 An investigation identified that the products were possibly manufactured from a different materia... Class II Zimmer GmbH
Apr 8, 2019 Drill, 15mm stop, 1x76mm, AO , Item Number 502015115 An investigation identified that the products were possibly manufactured from a different materia... Class II Zimmer GmbH
Apr 8, 2019 MoniTorr 10100 10-100 CSF Drainage System w/Patient Line One Way Valve MoniT... The firm has identified a complaint trend regarding breakage of the LimiTorr Transducer Mount sto... Class I Integra LifeSciences Corp.
Apr 8, 2019 Drill, cannulated, 2x95mm, AO, Item Number ST502015623 An investigation identified that the products were possibly manufactured from a different materia... Class II Zimmer GmbH
Apr 8, 2019 Drill, 2.5x87mm, AO, Item Number 502015137 An investigation identified that the products were possibly manufactured from a different materia... Class II Zimmer GmbH
Apr 8, 2019 Drill, 19mm stop, 1.9x87mm, AO, Item Number 502015131 An investigation identified that the products were possibly manufactured from a different materia... Class II Zimmer GmbH
Apr 8, 2019 V-TEK", standard-countersink, cannulated, AO, Item Number 28.66.111 An investigation identified that the products were possibly manufactured from a different materia... Class II Zimmer GmbH
Apr 8, 2019 Drill, 2.5x94mm, Stryker, Item Number 502015136 An investigation identified that the products were possibly manufactured from a different materia... Class II Zimmer GmbH
Apr 8, 2019 Concorde Lift, Expandable Interbody Device, spinal fusion implant Convex 9x21... A complaint trend was observed for post-operative loss of height and migration for Concorde Lift ... Class II DePuy Spine, Inc.
Apr 8, 2019 Drill Sys 2.7, 2x105mm, stryker, Item Number 502015106 An investigation identified that the products were possibly manufactured from a different materia... Class II Zimmer GmbH

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.