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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

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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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Browse Device Recalls

2,609 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,609 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 2,609 FDA device recalls in 2023.

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DateProductReasonClassFirm
Jul 12, 2023 QC (80 kVp) nanoDot D2DNS, Model Numbers: a) 18131-000; b) 18131-KIT; ... LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... Class II Landauer
Jul 12, 2023 nanoDot D2DXS, Model Numbers: a) 03062-1MO; b) 03062-3MO; c) 03062-OTO... LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... Class II Landauer
Jul 12, 2023 Calibrate (80 kVp) nanoDot D2DNS, Model Numbers: a) 18121-000; b)18121-K... LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... Class II Landauer
Jul 12, 2023 nanoDot B - item 2 of 3 for 03500-000, Model Number 03502-000; radiation moni... LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... Class II Landauer
Jul 12, 2023 FreeStyle Libre 2 Readers, REF: 71951-01 and 71953-01, used with FreeStyle Li... If blood glucose monitoring system users attempt to start a new sensor, when the old sensor wasn'... Class II Abbott Diabetes Care, Inc.
Jul 12, 2023 IMPIX MANTA+, REF numbers: a) B20171743, b) B20171753, c) B20171763, ... There is a potential for a product packaging non-conformity issue which presents as a pinhole in ... Class II Medicrea International
Jul 12, 2023 nanoDot D2DXN, Model Numbers: a) 03061-1MO; b) 03061-3MO; c) 03061-OTO... LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... Class II Landauer
Jul 12, 2023 GRANVIA-C, REF numbers: a)¿¿¿¿¿ A13111427, b)¿¿¿¿ A13112567, c)¿¿¿¿¿ A... There is a potential for a product packaging non-conformity issue which presents as a pinhole in ... Class II Medicrea International
Jul 12, 2023 QC (Cs-137) nanoDot D2DNS, Model Numbers: a) 18135-000; b) 18135-KIT; ... LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... Class II Landauer
Jul 12, 2023 IMPIX ALIF, REF numbers: a) B15111209, b) B15111212, c) B15111409, ... There is a potential for a product packaging non-conformity issue which presents as a pinhole in ... Class II Medicrea International
Jul 12, 2023 Calibrate (80 kVp) screened nanoDot D2DNS, Model Number 03064-OTO; radiation ... LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... Class II Landauer
Jul 12, 2023 nanoDot D2DXS, Model Numbers: a) 03063-1MO; b) 03063-3MO; c) 03063-OTO... LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... Class II Landauer
Jul 12, 2023 Carina Sub-Acute Care Ventilator Presence of polyether polyurethane (PE-PUR) and emission of 1,3-Dichloropropan-2-ol that exceed t... Class I Draeger Medical, Inc.
Jul 12, 2023 Calibrate (Cs-137) screened nanoDot D2DNS, Model Number 03065-OTO; radiation ... LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... Class II Landauer
Jul 12, 2023 Constancy (Cs-137) nanoDot D2DNN, Model Numbers: a) 18155-000 (EMEA number... LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... Class II Landauer
Jul 12, 2023 NanoDots, Model Number 04297-000; radiation monitoring dosimeter used with th... LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... Class II Landauer
Jul 12, 2023 QC (Cs-137) screened nanoDot D2DNS, Model Number 03067-OTO; radiation monitor... LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... Class II Landauer
Jul 12, 2023 nanoDot D2DNS, Model Numbers: a) 03056-000 (EMEA number VINLNAN002); b)... LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... Class II Landauer
Jul 12, 2023 IMPIX MANTA, REF numbers: a) A20150407, b) A20250407, c) A20350567, ... There is a potential for a product packaging non-conformity issue which presents as a pinhole in ... Class II Medicrea International
Jul 12, 2023 QC (80 kVp) nanoDot D2DNS, Model Numbers: a) 18130-000; b) 18130-KIT; ... LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... Class II Landauer
Jul 12, 2023 nanoDot D2DNN, Model Numbers: a) 18105-000; b) 18105-KIT; radiation moni... LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... Class II Landauer
Jul 12, 2023 CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006K Incorrect Laser Marking - Solera Awl Tip Tap Class II Medtronic Sofamor Danek USA, Inc
Jul 12, 2023 IMPIX C+, REF numbers: a) B20240104, b) B20240105, c) B20240106, d)... There is a potential for a product packaging non-conformity issue which presents as a pinhole in ... Class II Medicrea International
Jul 12, 2023 nanoDot D2DNN, Model Numbers: a) 03053-1MO; b) 03053-1WK ; c) 03053-3M... LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... Class II Landauer
Jul 12, 2023 IMPIX S, REF numbers: a) B15328071S, b) B15328073S, c) B15328074S, d... There is a potential for a product packaging non-conformity issue which presents as a pinhole in ... Class II Medicrea International
Jul 12, 2023 QC (Cs-137) nanoDot D2DNS, Model Numbers: a) 04225-000 (EMEA number VINLNA... LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... Class II Landauer
Jul 12, 2023 nanoDot D2DNS, for custom calibrate, OTO, Model Number 03033-OTO; radiation m... LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... Class II Landauer
Jul 12, 2023 nanoDot kit (contains nanoDot A, B, C), Model Number 03500-000; radiation mon... LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... Class II Landauer
Jul 12, 2023 nanoDot D2DNS, for custom calibrate, OTO, Model Numbers 03034-OTO; radiation ... LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... Class II Landauer
Jul 12, 2023 Calibrate (80 kVp) nanoDot D2DNS, Model Numbers: a) 18120-000; b) 18120-... LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... Class II Landauer
Jul 12, 2023 Reader, nanoDot adapter, EU Model Number VINLADA003; radiation monitoring dos... LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... Class II Landauer
Jul 12, 2023 nanoDot A - item 1 of 3 for 03500-000, Model Number 03501-000; radiation moni... LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... Class II Landauer
Jul 12, 2023 QC (80 kVp) screened nanoDot D2DNS, Model Number 03066-OTO; radiation monitor... LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... Class II Landauer
Jul 12, 2023 The following Pro.specta Emission Computed Tomography Systems that were manuf... During a whole-body planar scan with auto-contour, there is a possibility the short-linear drive ... Class II Siemens Medical Solutions USA, Inc.
Jul 12, 2023 The Air/Water Valve is provided/used with the following Endoscopes: ULTRASON... The air/water valve MAJ-1444 used with OER-Pro and OER-Elite may become damaged and result in lo... Class II Olympus Corporation of the Americas
Jul 12, 2023 Constancy (80 kVp) nanoDot D2DNN, Model Numbers: a) 18150-000 (EMEA number... LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... Class II Landauer
Jul 12, 2023 nanoDot D2DNS, Model Numbers: a) 03057-1MO; b) 03057-3MO; c) 03057-OT... LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... Class II Landauer
Jul 12, 2023 nanoDot D2DNS, Model Numbers: a) 18100-000; b) 18100-1MO; c) 18100-2MO... LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... Class II Landauer
Jul 11, 2023 EMBLEM MRI S-ICD Pulse Generator Model A219; Subcutaneous Implantable Cardiov... There is a potential for a rare interaction between the EMBLEM S-ICD and LATITUDE communicator, w... Class II Boston Scientific Corporation
Jul 11, 2023 EMBLEM S-ICD Pulse Generator Model A209; Subcutaneous Implantable Cardioverte... There is a potential for a rare interaction between the EMBLEM S-ICD and LATITUDE communicator, w... Class II Boston Scientific Corporation
Jul 10, 2023 Atellica CH LDL Cholesterol- In vitro diagnostic use in the quantitative det... Potential for reagent carryover on the Atellica CH 930 resulting in a positive bias that could im... Class II Siemens Healthcare Diagnostics, Inc.
Jul 10, 2023 SurgiCount+ Software Application-indicated as an adjunctive technology for au... Potential for current software to miscount when scanning in multiple sponge-products from the sam... Class II Stryker Corporation
Jul 10, 2023 Atellica CH Total Bilirubin_2 -In vitro diagnostic use in the quantitative d... Potential for reagent carryover on the Atellica CH 930 resulting in a positive bias that could im... Class II Siemens Healthcare Diagnostics, Inc.
Jul 10, 2023 Atellica¿ CH HDL Cholesterol- In vitro diagnostic use in the quantitative d... Potential for reagent carryover on the Atellica CH 930 resulting in a positive bias that could im... Class II Siemens Healthcare Diagnostics, Inc.
Jul 10, 2023 Atellica CH Gamma-Glutamyl Transferase-IIn vitro diagnostic use in the quanti... Potential for reagent carryover on the Atellica CH 930 resulting in a positive bias that could im... Class II Siemens Healthcare Diagnostics, Inc.
Jul 7, 2023 procedural kits containing ultrasonic transmission gel, Item Numbers: a)¿¿¿... Ultrasound gel mislabeled with inappropriate use. Class II Advance Medical Designs, Inc.
Jul 7, 2023 Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 2... Ultrasound gel mislabeled with inappropriate use. Class II Advance Medical Designs, Inc.
Jul 7, 2023 LIF AMP, Adjustable Awl, REF 117-165, Part of the AMP System. Used with Spine... Awl instrument adjustable drill button assembly assembled in the incorrect orientation, preventin... Class II Alphatec Spine, Inc.
Jul 7, 2023 Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20... Ultrasound gel mislabeled with inappropriate use. Class II Advance Medical Designs, Inc.
Jul 7, 2023 Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 2... Ultrasound gel mislabeled with inappropriate use. Class II Advance Medical Designs, 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.