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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

5,428 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 5,428 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 5,428 FDA device recalls.

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DateProductReasonClassFirm
Mar 17, 2014 Oxoid Legionella Pneumo Groups 2-14, DR0802M, containing 50 tests per box. T... A reagent contained within the product may return false negative results. Class II Remel Inc
Mar 17, 2014 Oxoid Legionella Latex Test, DR0800M, containing 50 tests per box. The box c... A reagent contained within the product may return false negative results. Class II Remel Inc
Mar 15, 2014 The Claymount Harmony is a grid cabinet designed to accept a digital x-ray im... Claymount Assemblies BV is recalling the Harmony2 model of Harmony Bucky because 1) the devices a... Class II Claymount Assembli
Mar 15, 2014 The Claymount Harmony is a grid cabinet designed to accept a digital x-ray im... Harmony1 models of the Harmony Bucky is incorrectly labeled in that the label does not list the m... Class II Claymount Assembli
Mar 14, 2014 K-Lite Knee 2 Stays with Visco, Model No. 122015. Product Usage: The prod... Breg is recalling the Economy Elastic Knee Sleeve Open and K-Lite Knee 2 Stays with Visco because... Class II Breg Inc
Mar 14, 2014 Economy Elastic Knee Sleeve Open, Model No. 121414 and 121415. Product Usa... Breg is recalling the Economy Elastic Knee Sleeve Open and K-Lite Knee 2 Stays with Visco because... Class II Breg Inc
Mar 13, 2014 Pressure Monitoring Tubing, PM6006. Pressure Monitoring Tubing (PM series) ... The products are labeled as sterile but were not sterilized. Class II Merit Medical Systems, Inc.
Mar 13, 2014 5X300 MM Curved Cannula, Arm 1 for use with daVinci SI Surgical System, mode... Intuitive Surgical has become aware of the potential for certain lots of the Single-Site 5mm Curv... Class II Intuitive Surgical, Inc.
Mar 13, 2014 5X250 MM Curved Cannula, Arm 2 for use with daVinci SI Surgical System, mode... Intuitive Surgical has become aware of the potential for certain lots of the Single-Site 5mm Curv... Class II Intuitive Surgical, Inc.
Mar 13, 2014 Merit Custom Syringe Kit, Convenience Kit, I.R. Embolization Pack, K02-01010A... The products are labeled as sterile but were not sterilized. Class II Merit Medical Systems, Inc.
Mar 13, 2014 Cobas c8000 Modular Analyzer Series Cobas c502, Part Number 5964067001, a c... The Initial Cassette Volume Check (ICVC) is not activated on the cobas c 502 module of the cobas ... Class II Roche Diagnostics Operations, Inc.
Mar 13, 2014 5X250 MM Curved Cannula, Arm 1 for use with daVinci SI Surgical System, mode... Intuitive Surgical has become aware of the potential for certain lots of the Single-Site 5mm Curv... Class II Intuitive Surgical, Inc.
Mar 13, 2014 5X300 MM Curved Cannula, Arm 2 for use with daVinci SI Surgical System, mode... Intuitive Surgical has become aware of the potential for certain lots of the Single-Site 5mm Curv... Class II Intuitive Surgical, Inc.
Mar 5, 2014 Fassier-Duval IM Telescopic System. Orthopedic intramedullary rod implant. ... The outer package label contained the incorrect length of the device. There is a label on the out... Class II Pega Medical Inc.
Feb 27, 2014 Medtronic, External neurostimulator, ENS (37021) & ENS (37022). Including t... Medtronic neurostimulators (used with pain and deep brain stimulation therapy) have a cycling fea... Class II Medtronic Neuromodulation
Feb 27, 2014 Medtronic neurostimulators. Restore (37711), RestoreADVANCED (37713), Restore... Medtronic neurostimulators (used with pain and deep brain stimulation therapy) have a cycling fea... Class II Medtronic Neuromodulation
Feb 27, 2014 Medtronic Activa RC (37612), Activa PC (37601), Activa SC (37602), Activa SC... Medtronic neurostimulators (used with pain and deep brain stimulation therapy) have a cycling fea... Class II Medtronic Neuromodulation
Feb 27, 2014 PowerPort Slim Implantable Port, indicated for patient therapies requiring re... Labeling discrepancy.The label states that the implantable port contains silicone suture plugs, h... Class II Bard Access Systems
Feb 26, 2014 Part 475625, Intramedullary Bone Saw, Cam Assembly Size 13 mm, The Biom... Incorrect labeling on specific lots of the Intramedullary Bone Saw. The Saw Blade Assembly was id... Class II Biomet, Inc.
Feb 26, 2014 Part 475620 Intramedullary Bone Saw CAM Assembly Size 12mm, A unique an... Incorrect labeling on specific lots of the Intramedullary Bone Saw.The Saw Blade Assembly was ide... Class II Biomet, Inc.
Feb 26, 2014 Part 475630, Intramedullary Bone Saw, Cam Assembly Size 14 mm, The Bi... Incorrect labeling on specific lots of the Intramedullary Bone Saw. The Saw Blade Assembly was id... Class II Biomet, Inc.
Feb 26, 2014 Novocastra Liquid Mouse Monoclonal Antibody Glutathione S-Transferase pi (NCL... Novocastra Liquid Mouse Monoclonal Antibody Glutathione S-Transferase pi (Product Code: NCL-L-GS... Class II Leica Microsystems, Inc.
Feb 19, 2014 Heparin I.V. Flush Syringe is available is pre-filled polypropylene syringes,... The bar code that is printed on the Master Carton label does not correspond to the product code f... Class III Medefil Incorporated
Feb 18, 2014 Oxoid Vancomycin 30 mcg, each cartridge contains 50 susceptibility discs, CT0... Some of the discs may not be impregnated with the antibiotic. Class II Remel Inc
Feb 17, 2014 Triton FP Infusion Pump, Part Number 400000, packaged in boxes. The Triton... WalkMed Infusion is initiaing a recall on their Triton FP Infusion Pump, Part Number 400000 due t... Class II WalkMed Infusion, LLC
Feb 14, 2014 Spacelabs Healthcare G2 Clinical Access Mislabeled CDs for PN: 063-1829-11 Re... Spacelabs has voluntarily recalled G2 Clinical Access Software CD because the programs installed ... Class II Spacelabs Healthcare, Llc
Feb 10, 2014 BencoDental tartar & stain remover ultrasonic cleaning solution Product Us... As the result of a complaint to Heraeus Kulzer's customer service department, Heraues Kulzer is r... Class II Heraeus Kulzer, LLC.
Feb 7, 2014 FMP X-alt Acetabular Liner This acetabular liner is intended for use with ... Packaging error -- two different types and sizes of acetabular liners used during hip replacement... Class II Djo Surgical
Feb 6, 2014 Medtronic Everest 20cc Inflation Device; Model Number and Catalog Number: AC2... Incorrect master label. Class III Medtronic Vascular
Feb 5, 2014 Synthes 5.0mm Variable Locking Screw This device is part of the Variable A... Labeling correction: The package insert in one 5.0mm Variable Locking Screw package was a GP0006 ... Class II Synthes, Inc.
Feb 5, 2014 Product Brand Name(s): Alere Triage¿ TOX+MTD Drug Screen, Catalog Number 9440... Alere San Diego, Inc. is initiating a recall of the Alere Triage¿ TOX Drug Screen, Catalog Number... Class II Alere San Diego, Inc.
Feb 3, 2014 OneTray Sealed Sterilization Containers Product Usage: A rigid sterilizat... The wrong sterilization time was on the label. The label lists Steam Gravity 10 - 34 minutes at ... Class II Innovative Sterlization Technologies LLC
Jan 30, 2014 Synthes CMF Battery Powered Driver, Part no. 305.840. Used to place screws i... The CMF Battery Powered Driver graphic case contains outlines of the Battery Powered Driver, tap... Class II Synthes, Inc.
Jan 28, 2014 AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002, diopte... Certain Silicone TECNIS IOLs may be labeled with the incorrect diopter power. Class II AMO Puerto Rico Manufacturing, Inc.
Jan 27, 2014 Synthes 3.2 mm Guide Wire 400mm. Used for guiding the TFN Helical Blade an... Synthes 3.2 mm Guide Wire 400mm included an incorrect raw material listed on the label. Class II Synthes, Inc.
Jan 24, 2014 Oxoid Legionella BCYE Growth Supplement, For 500 ml of medium, SR0110C, packa... The product may contain high levels of microbial contamination Class II Remel Inc
Jan 24, 2014 NxStage PureFlow-B Solution; Model/Catalog Number: RFP-401. Product is packa... Mislabeled product. Class II NxStage Medical, Inc.
Jan 24, 2014 Philips HeartStart XL+ Defibrillator/Monitor Model: 861290 The HeartStart... HeartStart XL+ battery charge time to 100% capacity at 35¿C (95¿F) is slightly longer than the sp... Class II Philips Medical Systems, Inc.
Jan 21, 2014 Product Name: HER2 CISH pharmDx Kit Catalog/Model number: SK109, lot 2000091... Dako has initiated a recall of HER2 CISH pharmDxTM Kit because weak red signals have been observed. Class II Dako North America Inc.
Jan 16, 2014 LOCATOR¿ Implant Attachment System. The LOCATOR¿ Implant Attachment System... Zest Anchors, LLC is voluntarily recalling specific lots of LOCATOR¿ Implant Attachment Systems b... Class II Zest Anchors LLC
Jan 10, 2014 Liquid Mouse Monoclonal Antibody CD15 (NCL-L-CD15), a liquid tissue culture s... Product does not function as intended up to the expiry date on the product labeling. There is a ... Class II Leica Microsystems, Inc.
Jan 9, 2014 Restoris Multicompartmental Knee (MCK) System is an implant system designed t... The product may be mislabeled and could result in the incorrect implant being used. Class II Mako Surgical Corporation
Jan 8, 2014 ANSPACH Cutting bur, 3 mm Diamond Ball, Standard Length. REF L-3SD Use with L... Anspach product code L-3SD contained product code S-3SD which is shorter in length than the label... Class II The Anspach Effort, Inc.
Jan 6, 2014 Medtronic GRAFTON (R) DBM, Flex 2.5cm x 10cm, REF T42100, Rx only, STERILE A,... Product was labeled as being measured as 2.5 cm x 10 cm, but contained product that measured as 2... Class II Medtronic Sofamor Danek USA Inc
Jan 6, 2014 Tapered Screw-Vent Implant, MTX, 4.7mm x 11.5mm, 4.5mm Platform. Catalog Numb... Zimmer Dental is conducting a voluntary recall of a single lot of the Tapered Screw-Vent Implant,... Class II Zimmer Dental Inc
Jan 6, 2014 cobas¿ PCR Urine Kit 100 PKT IVD cobas¿ PCR Female Swab Kit 100 PKT IVD cob... Numerous complaints have been filed that leaking cobas ¿ PCR media 4.3 mL IVD have been received ... Class II Roche Molecular Systems, Inc.
Jan 3, 2014 Composix L/P with Echo PS 10" X 13" Product Code 0144113 The Composix L/P ... Product labeling does not match product configuration. Class II Davol, Inc., Subs. C. R. Bard, Inc.
Jan 3, 2014 Composix L/P with Echo PS 6" X 8" Product Code 0144680 The Composix L/P Me... Product labeling does not match product configuration. Class II Davol, Inc., Subs. C. R. Bard, Inc.
Dec 19, 2013 Locking Cortical Screw 3.5mmX38mm REF 8161-35-038 3.5mmx38mm Locking Cortical Screw, implants are being recalled since an investigation identified ... Class II Biomet, Inc.
Dec 18, 2013 Radial Assist RAD BOARD, used to support the weight of a patient's arm and s... Merit Medical Systems, Inc. is voluntarily recalling one lot (B507171) of RAD BOARD RB 100 device... Class II Merit Medical Systems, 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.