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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

5,543 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 5,543 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 5,543 FDA device recalls.

Clear
DateProductReasonClassFirm
Feb 3, 2020 TRUMATCH Orthognathic - Full Bimaxillary Surgical Kit, Catalog Number SD980.001 Custom surgical kits contain a plate different than indicated by the package labeling. Class II Materialise N.V.
Jan 27, 2020 Truliant Splined Stem Extension, 18mm x 120mm - Product Usage: The devices ar... These Truliant Splined Stem Extension, 18mm x 120mm were found to have a labeling error. The uppe... Class II Exactech, Inc.
Jan 27, 2020 fridababy SmileFrida the TOOTHHUGGER 18+ months Triple Angle Brush Cleans A... FridaBaby has been made aware through customer reports that the product is being used outside of ... Class II Fridababy LLC
Jan 22, 2020 Triton Canister System (finished part numbers FG 12009, for 3L canisters, and... Some Canister Scanning Labels used to calibrate the Triton Canister System have a color variance.... Class II Stryker Instruments Div. of Stryker Corporation
Jan 20, 2020 Fentanyl Reagent Kit, Product N. CC444, Contains: FENT R1 Reagent and FENT R2... Labeled for diagnostic use and sold to clinical labs without a 510(k). Firm corrected labeling t... Class II Carolina Liquid Chemistries Corp
Jan 15, 2020 Monoject Bluntfill with Filter, 18G x 1-1/2" Item Code 11811022F. Used for d... Non-sterile product was shipped to customers. Product package is labeled as both "STERILE" and "... Class II Cardinal Health 200, LLC
Jan 15, 2020 Monoject Hypodermic Safety Needle 25G x 5/8" Item Code 1182558 - Product Usa... Non-sterile product was shipped to customers. Product package is labeled as both "STERILE" and "... Class II Cardinal Health 200, LLC
Jan 15, 2020 BARD Access Systems PowerPort ClearVUE Slim Implantable Port With Smooth Sept... The catheter locks for the lot may contain an 8Fr catheter lock instead of a 6Fr catheter lock pe... Class II Bard Peripheral Vascular Inc
Jan 15, 2020 Monoject 3mL Syringe with Hypodermic Safety Needle, 22G x 1-1/2 . Item Code 1... Non-sterile product was shipped to customers. Product package is labeled as both "STERILE" and "... Class II Cardinal Health 200, LLC
Jan 15, 2020 Monoject Hypodermic Safety Needle 30G X 1/2" Item Code 1183005 - Product Usag... Non-sterile product was shipped to customers. Product package is labeled as both "STERILE" and "... Class II Cardinal Health 200, LLC
Jan 14, 2020 Ormco Damon Q2 Orthodontic Metal Bracket, Part No. 491-9834, L3R Hi Tq Hook, ... The bracket torque was mislabeled on the packaging. Class II Ormco/Sybronendo
Jan 3, 2020 Custom procedure packs, containing Clearlink Continu-Flo, labeled as follows:... ROi CPS, LLC manufactured custom procedure packs using Clearlink Continu-Flo devices which were s... Class II ROi CPS LLC
Dec 27, 2019 WRIGHT EVOLVE Proline Head, Size: +2, OD: 22mm, REF 496H222 Two lots of EVOLVE Modular Radial Head could have the wrong size product in the package. Both th... Class II Wright Medical Technology, Inc.
Dec 27, 2019 WRIGHT EVOLVE Proline Head, Size: +2, OD: 20mm, REF 496H220 Two lots of EVOLVE Modular Radial Head could have the wrong size product in the package. Both th... Class II Wright Medical Technology, Inc.
Dec 23, 2019 Jamshidi Bone Marrow Aspiration Needle Item Number: 00-1103-007-00 Potential for the expiration date on the outer label that was applied by Zimmer Biomet to exceed ... Class II Zimmer Biomet, Inc.
Dec 20, 2019 Custom Healthcare Systems, Inc. Inpatient Dialysis Kit PAK-19244. Single use... A component (1961 TELFA PAD 2 X 3) contains LATEX and was used in the Medical Convenience Kit(PAK... Class II Custom Healthcare Systems, Inc.
Dec 17, 2019 AMS 700 100 mL, Spherical Reservoir with InhibiZone, Part No. 72404156 - Prod... A labeling discrepancy incorrectly labeled AMS 700 100mL Conceal Low Profile Reservoir with Inhib... Class II Boston Scientific Corporation
Dec 17, 2019 Conformable Thoracic Stent Graft, Rx only, Sterile EO - Product Usage: This d... The incorrect label was placed on both the primary and secondary package. Class II W L Gore & Associates, Inc.
Dec 17, 2019 Ref 801168, MPS Top Cover Replacement Kit, 1 UNITS, UDI: (01)2 0634624 81168... Additive and Arrest Agent Labels on the MPS Top Cover Replacement Kit, a replacement for worn or ... Class II Quest Medical, Inc.
Dec 16, 2019 Stratum Lapidus Plate - Small Rt, Part No. STRM-LAP-SMR, UDI 00817701025467. ... The product contains a different plate than indicated by the package labeling. The product is lab... Class II Nextremity Solutions
Dec 12, 2019 Arrow Arterial Catherization Kit-20 Ga. x 4.45 cm Radiopaque Polyurethane ove... The lidstock label incorrectly displays a MR (Magnetic Resonance ) Conditional symbol (instea... Class II Arrow International Inc
Dec 11, 2019 Model 250D Ambulatory Blood Pressure Monitor labeled under the following bran... The Bravo Mini (Model 250D), Agilis Mini (Model 250D), and NBP One (Model 250D) are being recalle... Class II Suntech Medical, Inc.
Dec 11, 2019 Brasseler USA KM169-39-76 Steinmann Pin Single Diamond Smooth, Diameter 2.8 m... 103 packaged and labeled tubes (103 product tubes with 6 pins per tube) of KM168-39-76 Single Dia... Class II Brasseler USA I Lp
Dec 3, 2019 Exactech equinoxe PLATFORM FRACTURE, HUMERAL STEM, CEMENTED, Right, 6.5mm, RE... Labels with incorrect translations were identified by Exactech is a distributor in the Netherland... Class II Exactech, Inc.
Dec 3, 2019 Exactech equinoxe PLATFORM FRACTURE, HUMERAL STEM, CEMENTED, Right, 10.5mm, R... Labels with incorrect translations were identified by Exactech is a distributor in the Netherland... Class II Exactech, Inc.
Dec 2, 2019 BioPince Full Core Biopsy Instrument 16ga x 15cm.,Use with Optional CO-Axial... Incorrect product labeling. Class II Argon Medical Devices, Inc
Dec 2, 2019 Medical convenience trays and kits, labeled as: Medical Action Industries,... The kits contain a bottle of saline solution which may exceed the USP specified pH requirements o... Class II Medical Action Industries, Inc. 306
Nov 24, 2019 Terumo AZUR Peripheral Coil System, Detachable 35, Framing Coil, REF numbers ... The devices may be missing the implant coil. Class II Microvention, Inc.
Nov 24, 2019 Terumo AZUR CX Peripheral Coil System, Detachable 18, CX Coil, REF numbers 45... The devices may be missing the implant coil. Class II Microvention, Inc.
Nov 24, 2019 Terumo AZUR Peripheral Coil System, Detachable 35, Helical HydroCoil Emboliza... The devices may be missing the implant coil. Class II Microvention, Inc.
Nov 24, 2019 Terumo AZUR Peripheral Coil System, Detachable 18, Helical HydroCoil Emboliza... The devices may be missing the implant coil. Class II Microvention, Inc.
Nov 24, 2019 Terumo AZUR Peripheral Coil System, Detachable 18, Framing Coil, REF numbers ... The devices may be missing the implant coil. Class II Microvention, Inc.
Nov 24, 2019 Terumo AZUR CX Peripheral Coil System, Detachable 35, CX Coil, REF numbers 45... The devices may be missing the implant coil. Class II Microvention, Inc.
Nov 22, 2019 MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Emboliza... The devices may be missing the implant coil. Class II Microvention, Inc.
Nov 22, 2019 MicroVention Terumo Microplex 18, Platinum Coil System, Endovascular Emboliza... The devices may be missing the implant coil. Class II Microvention, Inc.
Nov 22, 2019 MicroVention Terumo HydroSoft 10, HydroCoil Embolic System, Endovascular Embo... The devices may be missing the implant coil. Class II Microvention, Inc.
Nov 22, 2019 MicroVention Terumo Microplex 18, Platinum Embolization Coil, Cosmos 18, Ster... The devices may be missing the implant coil. Class II Microvention, Inc.
Nov 22, 2019 MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Emboliza... The devices may be missing the implant coil. Class II Microvention, Inc.
Nov 22, 2019 MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Emboliza... The devices may be missing the implant coil. Class II Microvention, Inc.
Nov 22, 2019 MicroVention Terumo Microplex, Platinum Coil System, Endovascular Embolizatio... The devices may be missing the implant coil. Class II Microvention, Inc.
Nov 22, 2019 MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Emboliza... The devices may be missing the implant coil. Class II Microvention, Inc.
Nov 22, 2019 MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Emboliza... The devices may be missing the implant coil. Class II Microvention, Inc.
Nov 22, 2019 MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Emboliza... The devices may be missing the implant coil. Class II Microvention, Inc.
Nov 22, 2019 MicroVention Terumo HydroFrame 18, HydroCoil Embolic System, Endovascular Emb... The devices may be missing the implant coil. Class II Microvention, Inc.
Nov 22, 2019 MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Emboliza... The devices may be missing the implant coil. Class II Microvention, Inc.
Nov 22, 2019 MicroVention Terumo Microplex 18, Platinum Coil System, Endovascular Emboliza... The devices may be missing the implant coil. Class II Microvention, Inc.
Nov 22, 2019 MicroVention Terumo HydroSoft 10, HydroCoil Embolic System, Endovascular Embo... The devices may be missing the implant coil. Class II Microvention, Inc.
Nov 21, 2019 The products involved are DeWALT laser distance measurers, model numbers DW01... The products are labeled as Class II lasers. However, the level of laser radiation emitted by the... Class II STANLEY BLACK & DECKER INC.
Nov 18, 2019 Gore DrySeal Flex Introducer Sheath, Catalog #DSF1433, 33cm 14FR, Sterile. T... The devices were mislabeled with the incorrect product size resulting in 16Fr devices being label... Class II W. L. Gore & Associates Inc.
Nov 14, 2019 Cordis S.M.A.R.T. CONTROL /S.M.A.R.T. Vascular Stent System. The S.M.A.R.... Cordis has initiated a labeling correction for S.M.A.R.T. and PRECISE stents due to incorrect MRI... Class II Cardinal Health 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.