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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.