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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

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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

2,907 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,907 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 2,907 FDA device recalls in 2015.

Clear
DateProductReasonClassFirm
May 13, 2015 Optilite Analyser, Product Code: IE700 Product Usage: The Thermo Scientif... Potential risk of the Optilite lid/cover falling suddenly and causing injury when not placed in t... Class II The Binding Site Group, Ltd.
May 13, 2015 3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws; . the C... Certain lots of the 3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws were foun... Class II Synthes, Inc.
May 12, 2015 T.A.L.O.N (Tactically Advanced Lifesaving Intraosseous Needle) 15G x 38.5 mm ... Potential breach in sterility Class II Vidacare Corporation
May 12, 2015 ReUnion TSA Shoulder System, Standard SR Humeral Head Trial, 48X18, Catalog n... A package labeled as Part #5901-S-4818, Lot MAC7C14, standard humeral head trial, contained part... Class II Stryker Howmedica Osteonics Corp.
May 11, 2015 ORTHOFIX Centurion POCT System Drill Guide PN 69-1010 and PN 69-1012. Drill G... There is a possibility that the thumb button remains in the depressed (unlocked) position allowin... Class II Orthofix, Inc
May 11, 2015 EVOTECH Endoscope Cleaner and Reprocessing System 208V, P/N 50004. The ASP... Advanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor ... Class II Advanced Sterilization Products
May 11, 2015 Alkaline Wash, List number 9D31-20, a cleaning solution used by the Abbott Ar... The product is leaking from the cap and crystallization was noted as present around the cap. Class II Abbott Laboratories
May 11, 2015 Factor deficient plasma for the Siemens BCS¿ / BCS¿ XP System. In vitro di... Discrepancies for Siemens BCS / BCS XP with dilution studies; erroneously high Factor IX results ... Class II Siemens Healthcare Diagnostics, Inc.
May 11, 2015 EVOTECH Endoscope Cleaner and Reprocessing System 220-230V, P/N 50004-002. ... Advanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor ... Class II Advanced Sterilization Products
May 8, 2015 RaySearch RayStation 2.5, 3.0, 3.5 and 4.0; Radiation Therapy Treatment P... RaySearch Laboratories AB became aware of an issue with the dose calculation for some imported VM... Class II RAYSEARCH LABORATORIES AB
May 8, 2015 0210-312-000-Woundcare Replacement kit with soft tip; 0210-318-000; Woundcare... Potential sterility breach in the packaging. Class II Stryker Instruments Div. of Stryker Corporation
May 8, 2015 Spacelabs qube Compact Monitor, Model 91390. The monitor is functioning as e... The input power can fail even though the power source at the wall has not been interrupted. In ad... Class II Spacelabs Healthcare Inc
May 8, 2015 Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube with TaperGua... Reports where patients who recently switched from the current Shiley Neonatal and Pediatric produ... Class I Covidien LP (formerly Nellcor Puritan Bennett I...
May 8, 2015 Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube, Cuffless. M... Reports where patients who recently switched from the current Shiley Neonatal and Pediatric produ... Class I Covidien LP (formerly Nellcor Puritan Bennett I...
May 8, 2015 Toshiba Aquilion CT System TSX-301B If two specific operations are performed in multi-phase helical scanning, the acquired raw data m... Class II Toshiba American Medical Systems Inc
May 8, 2015 Celesteion PCA-9000A/2 PET/CT System It was found that if specific operations are performed in multi-phase helical scanning, the acqui... Class II Toshiba American Medical Systems Inc
May 8, 2015 Toshiba Aquilion CT System TSX-101A If two specific operations are performed in multi-phase helical scanning, the acquired raw data m... Class II Toshiba American Medical Systems Inc
May 8, 2015 BrainLAB Image Guided Surgery (IGS) System, Stereotaxic Instrument navigation... Instances of data sets not being accurately registered to the patient anatomy were observed. Class II Brainlab AG
May 8, 2015 Toshiba Aquilion CT System TSX-302A If two specific operations are performed in multi-phase helical scanning, the acquired raw data m... Class II Toshiba American Medical Systems Inc
May 8, 2015 Toshiba Aquilion CT System TSX-301A If two specific operations are performed in multi-phase helical scanning, the acquired raw data m... Class II Toshiba American Medical Systems Inc
May 8, 2015 Toshiba Aquilion CT System TSX-303A If two specific operations are performed in multi-phase helical scanning, the acquired raw data m... Class II Toshiba American Medical Systems Inc
May 8, 2015 Toshiba Aquilion CT System TSX-301C If two specific operations are performed in multi-phase helical scanning, the acquired raw data m... Class II Toshiba American Medical Systems Inc
May 8, 2015 Gyrus ACMI Diego Elite Tubeset; intended for cutting, coagulation, drilling, ... Potential lack of sterility assurance. Class II Gyrus Acmi, Incorporated
May 8, 2015 Gyrus ACMI Diego Elite Tubeset, intended for cutting, coagulation, drilling, ... Potential lack of sterility assurance. Class II Gyrus Acmi, Incorporated
May 8, 2015 Ethicon Fast Absorbing Plain Gut - MultiPass Needles, Sterile, Absorbable Sur... Ethicon Fast Absorbing Surgical Gut (Plain) Suture is being recalled because the labeling on the ... Class II Ethicon, Inc.
May 7, 2015 Triglycerides GPO. In vitro test for the quantitative determination of tri... Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. R... Class II Roche Diagnostics Operations, Inc.
May 7, 2015 Cholesterol CHOD-PAP. In vitro diagnostic reagent system intended for use ... Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. R... Class II Roche Diagnostics Operations, Inc.
May 7, 2015 Ocean Water Seal Chest Drain, SINGLE W/AC P/N: 2002-100 Chest drains have a missing o-ring Class II Atrium Medical Corporation
May 7, 2015 LDL-Cholesterol gen.2. The Boehringer Mannheim Direct LDL-Cholesterol tes... Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. R... Class II Roche Diagnostics Operations, Inc.
May 7, 2015 Cholesterol Gen.2. The cassette COBAS Integra Cholesterol Gen.2 (CHOL2) co... Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. R... Class II Roche Diagnostics Operations, Inc.
May 7, 2015 LDL-Cholesterol plus gen.2. The Boehringer Mannheim Direct LDL-Cholestero... Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. R... Class II Roche Diagnostics Operations, Inc.
May 7, 2015 Oasis Dry Suction Water Seal Chest Drain, DRY SINGLE W/AC P/N: 3600-100 Chest drains have a missing o-ring Class II Atrium Medical Corporation
May 7, 2015 Lactate. Intended for use on COBAS INTEGRA 800 and 400 plus systems, cobas... Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. R... Class II Roche Diagnostics Operations, Inc.
May 7, 2015 EXPRESS Dry Seal Chest Drain, Single Collection P/N: 4000-100N Chest drains have a missing o-ring Class II Atrium Medical Corporation
May 7, 2015 Creatinine Plus. Intended for use on Hitachi/MODULAR systems for the quant... Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. R... Class II Roche Diagnostics Operations, Inc.
May 7, 2015 Triglycerides/Glycerol Blanked. In vitro test for the quantitative determi... Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. R... Class II Roche Diagnostics Operations, Inc.
May 7, 2015 Uric Acid plus ver.2 In vitro test for the quantitative determination of u... Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. R... Class II Roche Diagnostics Operations, Inc.
May 7, 2015 HDL-Cholesterol plus gen.3.; and Small Supersized Intended for use on COBA... Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. R... Class II Roche Diagnostics Operations, Inc.
May 7, 2015 Ocean Water Seal Chest Drain, Single Collection W/AC, P/N: 2002-000 Chest drains have a missing o-ring Class II Atrium Medical Corporation
May 7, 2015 Creatinine Plus ver. 2. Intended for use on COBAS INTEGRA systems , cobas ... Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. R... Class II Roche Diagnostics Operations, Inc.
May 7, 2015 HDL-Cholesterol gen.3. For the quantitative determination of high-density ... Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. R... Class II Roche Diagnostics Operations, Inc.
May 7, 2015 Treatment Planning and Delivery System Software version 3.6. ViewRay. Ind... The software was failing to determine new patient locations if imaging is not enabled during trea... Class II Viewray Incorporated
May 6, 2015 R3(TM) 22 MM I.D., 52 MM O.D. CONSTRAINED LINER, REF 71339152, QTY: (1), STER... The R3 Constrained outer liner locking groove diameter is 0.030 inches oversized and may not allo... Class II Smith & Nephew, Inc.
May 6, 2015 R3(TM) 28 MM I.D., 62 MM O.D. CONSTRAINED LINER, REF 71339162, QTY: (1), STER... The R3 Constrained outer liner locking groove diameter is 0.030 inches oversized and may not allo... Class II Smith & Nephew, Inc.
May 6, 2015 enGen Laboratory Automation System (enGen System), Product Code ENGEN, config... Recapper Caps may fall off of, or be knocked from sample tubes placed in the storage racks of ent... Class II Ortho-Clinical Diagnostics
May 6, 2015 The Rapidlab 1260 system is a blood gas analyzer used for laboratory testing ... D50 and D51 Diagnostic error codes are not functional. Class II Siemens Healthcare Diagnostics, Inc
May 6, 2015 VITROS Immunodiagnostic Products Signal Reagent, Product Code 1072693, Unique... The Immunodiagnostic Products Signal Reagent, Lot 3082 as the reagent packs may contain blank lab... Class III ORTHO-CLINICAL DIAGNOSTICS
May 6, 2015 Custom Cardiovascular Procedure Kits; Over-Pressure Safety Valves. For use... The Overpressure Safety Valve is not cleared with an indication for use on the arterial side of t... Class II Terumo Cardiovascular Systems Corp
May 6, 2015 R3(TM) 22 MM I.D., 56 MM O.D. CONSTRAINED LINER, REF 71339156, QTY: (1), STER... The R3 Constrained outer liner locking groove diameter is 0.030 inches oversized and may not allo... Class II Smith & Nephew, Inc.
May 6, 2015 syngo Workflow SLR; The information system syngo Workflow SLR is a digital ra... A potential exists for order transactions from interfaced HIS (Hospital Information System) syste... Class II Siemens Medical Solutions USA, 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.