Browse Device Recalls
113 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 113 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 113 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 4, 2021 | INJECTOR FORCEMAX LOWER 23G 3MM, model no. NM-400U-0323 - Product Usage: Used... | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial... | Class II | Aomori Olympus Co., Ltd. |
| Jan 4, 2021 | INJECTOR FORCEMAX LOWER 25G 6MM, model no. NM-400U-0625 - Product Usage: Used... | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial... | Class II | Aomori Olympus Co., Ltd. |
| Jan 4, 2021 | KD-620UR ELECTROSURGICAL SNARE, model no. KD-620UR - Product Usage: Used with... | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial... | Class II | Aomori Olympus Co., Ltd. |
| Jan 4, 2021 | PR-V614M 2-LUMEN CANNULA, model no. PR-V614M - Product Usage: Used with endos... | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial... | Class II | Aomori Olympus Co., Ltd. |
| Jan 4, 2021 | INJECTOR FORCEMAX UP 2.8MMCH 21G 6MM, model no. NM-400L-0621 - Product Usage:... | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial... | Class II | Aomori Olympus Co., Ltd. |
| Jan 4, 2021 | INJECTOR FORCEMAX UP 2.8MMCH 25G 6MM, model no. NM-400L-0625 - Product Usage:... | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial... | Class II | Aomori Olympus Co., Ltd. |
| Jan 4, 2021 | INJECTOR FORCEMAX UP 2.8MMCH 23G 6MM, model no. NM-400L-0623 - Product Usage:... | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial... | Class II | Aomori Olympus Co., Ltd. |
| Jan 4, 2021 | B7-2LA BALLOON CATHETER 13MM DIA 3.2, model no. B7-2LA - Product Usage: Used ... | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial... | Class II | Aomori Olympus Co., Ltd. |
| Jan 4, 2021 | SD-230U-20 ELECTROSURGICAL SNARE, model no. SD-230U-20 - Product Usage: Used ... | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial... | Class II | Aomori Olympus Co., Ltd. |
| Jan 4, 2021 | NEEDLEMASTER 3MMx 23G LOWER, model no. NM-610U-0323 - Product Usage: Used wit... | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial... | Class II | Aomori Olympus Co., Ltd. |
| Jan 4, 2021 | K-202 GUIDE SHEATH KIT 2.0MM, model no. K-202 - Product Usage: Used with endo... | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial... | Class II | Aomori Olympus Co., Ltd. |
| Jan 4, 2021 | KD-611L ELECTROSURGICAL KNIFE, model no. KD-611L - Product Usage: Used with e... | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial... | Class II | Aomori Olympus Co., Ltd. |
| Jan 4, 2021 | INJECTOR FORCEMAX 25G 2.5MM, model no. NM-400U-0425 - Product Usage: Used wit... | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial... | Class II | Aomori Olympus Co., Ltd. |
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.