Browse Device Recalls

39,969 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 39,969 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 39,969 FDA device recalls.

DateProductReasonClassFirm
Jul 13, 2023 Snowden-Pencer MIS DIAMOND-TOUCH CLAMP BOWEL 50 MM JAW 5MM, 32CM, RATCHETED,... Specific lots of the product have the potential to exhibit cracking or breaking of the rotation k... Class II Carefusion 2200 Inc
Jul 12, 2023 NanoDots, Model Numbers: a) BC30023, description: QC Set For Microstar Do... 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) 03051-1MO; b) 03051-3MO; c) 03051-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) 04217-000 (EMEA number... LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... Class II Landauer
Jul 12, 2023 IMPIX ALIF S/A, REF number B15241415; intervertebral fusion device - lumbar 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 (unexposed) nanoDot D2DNS, Model Numbers: a) 18140-000; b) 181... LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... Class II Landauer
Jul 12, 2023 PASS LP, REF numbers: a) B02315535Z, b) B02315540Z, c) B02315545Z, 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) 04293-000; b) 04293-KIT; radiation mon... LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... Class II Landauer
Jul 12, 2023 IMPIX TLIF, REF numbers: a) B15130607S, b) B15130609S, c) B15130611S, ... There is a potential for a product packaging non-conformity issue which presents as a pinhole in ... Class II Medicrea International
Jul 12, 2023 IMPIX 3D, REF numbers: a) B242C09122810, b) B242C10062810, c) B242C10... 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) 03060-1MO; b) 03060-3MO; c) 03060-OTO... LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... Class II Landauer
Jul 12, 2023 Beckman Coulter, IVD, REF: OSR61171, IgA, 4 x 14 mL R1, 4 x 11 mL R2 Lipemic interference failed to meet the performance specification listed within the IFU. Class II Beckman Coulter Inc.
Jul 12, 2023 Calibrate (Cs-137) nanoDot D2DNS, Model Numbers: a) 18125-000; b) 18125-... 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) 03055-1MO; b) 03055-3MO; c) 03055-OT... LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... Class II Landauer
Jul 12, 2023 QC (80 kVp) nanoDot D2DNS, Model Numbers: a) 04218-000 (EMEA number VINLNA... LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... Class II Landauer
Jul 12, 2023 Calibrate (Cs-137) nanoDot D2DNS, Model Numbers: a) 04224-000 (EMEA number... LANDAUER received reports indicating that some nanoDots may potentially be outside of the specifi... Class II Landauer
Jul 12, 2023 IMPIX DLIF, REF numbers: a) B16123509, b) B16123511, c) B16124009, ... 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 C - item 3 of 3 for 03500-000, Model Number 03503-000; 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) 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

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.