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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
Feb 5, 2015 Computed Tomography X-ray Systems Brilliance CT 64-channel with Essence techn... 5 issues. Fast Get Ready incorrectly enabled during service procedures. Contrast annotation miss... Class II Philips Medical Systems (Cleveland) Inc
Feb 4, 2015 FujiMedical Synapse Cardiovascular I ProSolv CardioVascular. A picture Ar... Measurement values in the EMR may not accurately reflect the actual measurement value on the Syna... Class II Fujifilm Medical Systems U.S.A., Inc.
Feb 4, 2015 Signature TKA GDE/MDL Set 04-05 (Femur & Tibia) The Signature Patient-Spec... Images belonging to a different patient were used for the production of the patient specific surg... Class II Materialise N.V.
Feb 4, 2015 Fujifilm Synapse Cardiovascular I ProSolv CardioVascular Synapse Cardiovascu... Under certain circumstances the patient Demographics in a report exported into the EMR may not m... Class II Fujifilm Medical Systems U.S.A., Inc.
Feb 4, 2015 NexGen TRABECULAR METAL FEMORAL AUGMENT BLOCK DISTAL ONLY, 20 MM Augment, Siz... One unit of the 20 mm augments was mislabeled as 5 mm and it was subsequently distributed. Class II Zimmer Trabecular Metal Technology, Inc.
Feb 3, 2015 GREER 2 ML Sterile Empty Vials 2-13 vial 25 ea - Silver Cap Potential for glass particles within the vials Class II Allergy Laboratories, Inc.
Feb 3, 2015 Philips Healthcare Allure BiPlane Series: Model 722013 Allura X... Monitor Ceiling Suspension system may fall Class II Philips Medical Systems, Inc.
Feb 3, 2015 Philips Healthcare Xper cardio systems Model : 722123 Product Usage: T... Monitor Ceiling Suspension system may fall Class II Philips Medical Systems, Inc.
Feb 3, 2015 Philips Healthcare Xper cardio systems R7.6 Model : 722133 Product Usage... Monitor Ceiling Suspension system may fall Class II Philips Medical Systems, Inc.
Feb 3, 2015 LFT v40 Femoral Head; Catalog Number 6260-9-032; V40 CoCr LFit Head 32mm/-4... Three customer complaints were received for the same batch of V40 LFIT Vitallium femoral heads (p... Class II Stryker Howmedica Osteonics Corp.
Feb 3, 2015 IntellaTip MiFi Open-Irrigated radiofrequency Ablation Catheters: Material n... Reports of formation of char adherent to the proximal part of the distal tip electrodes Class I Boston Scientific Corp
Feb 3, 2015 Philips Healthcare Xper vascular system Model : 722124 Product Usage: ... Monitor Ceiling Suspension system may fall Class II Philips Medical Systems, Inc.
Feb 3, 2015 Aspire HD, Full Field Digital, System, x-Ray, Mammographic; Model: FOR MS-10... User Manual lacks a description for handling some errors even though the system can be recovered... Class II Fujifilm Medical Systems U.S.A., Inc.
Feb 3, 2015 Synthes Inserter for Titanium Elastic Nails; The Inserter for Titanium Elasti... The Inserter has the potential for mechanical failures such as breakage of the main shaft of the ... Class II Synthes, Inc.
Feb 3, 2015 Philips Healthcare INTEGRIS cardio system Model : 722121 Product Usage:... Monitor Ceiling Suspension system may fall Class II Philips Medical Systems, Inc.
Feb 3, 2015 Philips Healthcare Allura Xper Series: Allura Xper FD10 Allura Xper FD10/10... Monitor Ceiling Suspension system may fall Class II Philips Medical Systems, Inc.
Feb 3, 2015 Philips Healthcare INTEGRIS H5000F/Allura 9F Model : 722017 Product Usa... Monitor Ceiling Suspension system may fall Class II Philips Medical Systems, Inc.
Feb 3, 2015 Philips Healthcare Xper vascular systems R7.6 Model : 722134 Product Usa... Monitor Ceiling Suspension system may fall Class II Philips Medical Systems, Inc.
Feb 3, 2015 Philips Healthcare INTEGRIS vascular System Model : 722122 Product Usag... Monitor Ceiling Suspension system may fall Class II Philips Medical Systems, Inc.
Feb 3, 2015 Manual Toothbrush; SilverCare Junior 2/6 years Antibacterial Toothbrush Made ... The toothbrush head can potentially disengage from the handle. Class II Norwex Usa Inc
Feb 2, 2015 Axial Torque Limiting Driver (1st generation) Product Usage: The Bradshaw... A component failure could cause a situation where the applied torque was significantly higher tha... Class II Bradshaw Medical Inc.
Feb 2, 2015 COMPASS SW Version 3.1, Catalog Number CS10-100, medical linear accelerator, ... Error in the software. During internal tests of the current development version of the Compass ... Class II Iba Dosimetry Gmbh
Feb 2, 2015 CADD" Medication Cassette Reservoir, 50mL, REF 21-7001-24 & 21-7301-24, Ster... Smiths Medical has become aware of an issue with specific lots of 50mL CADD" Medication Cassette ... Class II Smiths Medical ASD, Inc.
Feb 2, 2015 Invacare¿ Pronto¿ Air Personal Transporter (power wheelchair), Invacare Corp... The batteries used in the Invacare¿ Pronto¿ Air Personal Transporter models power wheelchairs hav... Class II Invacare Corporation
Feb 2, 2015 EVOLUTION MP TIBIAL BASE, REF ETPKN8SR, SIZE 8 RIGHT, TYPE PRIMARY, FIT CEMEN... Some units of the EVOLUTION Tibial Base was affected by a casting tool issue which caused varying... Class II Microport Orthopedics INC.
Jan 31, 2015 Various OxyTOTE Portable Oxygen System regulators, Valve Integrated Pressure ... The firm has become aware of the possibility of ignition and rupture (explosion) of a compressed ... Class I Western / Scott Fetzer Company
Jan 30, 2015 Maquet CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP) Power supply malfunction complaints related to suboptimal thermal management. Class II Maquet Datascope Corp - Cardiac Assist Division
Jan 30, 2015 Bard 100% Latex-Free Urinary Drainage Bag with Anti-Reflux Chamber and Bard E... Potential breach of the sterile barrier packaging. Class II C.R. Bard, Inc.
Jan 30, 2015 GE Healthcare Proteus XR/a with wall stand model number 2260354. Intended ... Potential breakage of the steel cable which supports the bucky device in certain wall stands of P... Class II GE Healthcare
Jan 30, 2015 Penner Patient Stretcher/Transfer Lift System Models 391000-1 and 392000-1 ... If the patient sits on either wing, not squarely on the center section of the Stretcher Lift, tip... Class II Penner Mfg Inc
Jan 29, 2015 Elekta Precise Treatment Table It is possible to position the Treatment Table with errors greater than 5mm and no inhibits are d... Class II Elekta, Inc.
Jan 28, 2015 Spacelabs Healthcare qube Compact Monitor, Model 91390. The Spacelabs He... Spacelabs Healthcare qube Bedside Monitors, Model 91390, are recalled because the firm has receiv... Class II Spacelabs Healthcare Inc
Jan 28, 2015 Spacelabs Healthcare XPREZZON Bedside Monitor, Model 91393. The Spacelabs He... Spacelabs Healthcare XPREZZON Bedside Monitors, Model 91393, are recalled because the firm has re... Class II Spacelabs Healthcare Inc
Jan 28, 2015 Persona Trabecular Metal Tibial Plate / Persona TM Tibia-Prosthesis, Knee, Pa... An increase in complaints of loosening and radiolucent lines. Class II Zimmer, Inc.
Jan 28, 2015 9F Plastic Dual Port; The port systems are totally implantable vascular acces... The dual port with catheters was not covered under FDA clearance. Class II Medical Components, Inc dba MedComp
Jan 27, 2015 GE Healthcare Engstrom Carestation, Engstrom Pro, Cart Only S/5 EC. GE model ... Potential failure of the caster mounting hardware, which may result in the ventilator falling/tip... Class II GE Healthcare
Jan 27, 2015 ADVIA Centaur Systems Progesterone Kit, (5 -pack); In Vitro Diagnostic; Catal... ADVIA Centaur Systems Progesterone Kit Lots Ending in 268 have a high bias on results greater th... Class II Siemens Healthcare Diagnostics, Inc
Jan 27, 2015 ADVIA Centaur Systems Progesterone Kit, (5-pack Ref); In Vitro Diagnostic C... ADVIA Centaur Systems Progesterone Kit Lots Ending in 268 have a high bias on results greater th... Class II Siemens Healthcare Diagnostics, Inc
Jan 27, 2015 ADVIA Centaur Systems Progesterone Kit, (1 -pack) In Vitro Diagnostic; Catal... ADVIA Centaur Systems Progesterone Kit Lots Ending in 268 have a high bias on results greater th... Class II Siemens Healthcare Diagnostics, Inc
Jan 26, 2015 NovaPlus Brand Warm Gel Infant Heel Gel Warmer, Item # V6391 NovaPlus Brand... Products without expiration date have the remote potential for minor burn Class II CooperSurgical, Inc.
Jan 26, 2015 Fisher Brand Gel Infant Heel Gel Warmers, Cat. No.: 22-024647 Fisher Bran... Products without expiration date have the remote potential for minor burn Class II CooperSurgical, Inc.
Jan 26, 2015 Haemonetics TEG Hemostasis System Level II Control, Catalog number: 8002. ... Specific lots of Level II Control Kits produce high Maximum Amplitude (MA) results, which are out... Class II Haemonetics Corporation
Jan 26, 2015 CooperSurgical Infant Heel Gel Warmers, P/N 20418 CooperSurgical The Infant ... Products without expiration date have the remote potential for minor burn Class II CooperSurgical, Inc.
Jan 26, 2015 MediChoice WarmGel Infant Heel Warmer, Item # 1643069911 MediChoice Liquid ... Products without expiration date have the remote potential for minor burn Class II CooperSurgical, Inc.
Jan 23, 2015 Bio-MAC Cannula (Needle) Set Devices are misbranded - failure to properly classify and obtain FDA clearance prior distribution Class II Biologic Therapies, Inc
Jan 23, 2015 Passport V Monitor, Multiparameter Patient Monitor(with Arrhythmia Detection ... An issue has been identified with Passport V Monitors invasive blood pressure function (IBP) whic... Class II Mindray DS USA, Inc. dba Mindray North America
Jan 23, 2015 Bio-PLASTY Cannula (Needle) Devices are misbranded - failure to properly classify and obtain FDA clearance prior distribution Class II Biologic Therapies, Inc
Jan 23, 2015 Philips DuraDiagnost X-Ray system, Stationary X-Ray System Radiographic Mode... Improper installation of Tube arm, and Wall stand may cause it to fall down, Improper installatio... Class II Philips Medical Systems, Inc.
Jan 23, 2015 MAX-TL 9.0 x 7.0 mm Implant, Catalog No. 15711K; Z-MAX Implant 9.0 x 7 mm Len... Z-MAX Implant, 9mm diameter, 7mm length labeled package, catalog number Z-MAX9-7, contained a MAX... Class II Southern Implants, Inc
Jan 23, 2015 Bio-CORE Cannula (Needle) Set Devices are misbranded - failure to properly classify and obtain FDA clearance prior distribution Class II Biologic Therapies, 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.