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 |
|---|---|---|---|---|
| Jul 27, 2023 | Reusable distal attachments Models: MH-462, MH-463, MH-464, MH-465, MH-466,... | The Distal Attachment contain di-2-ethylhexyl phthalate (DEHP), which exceeds the permissible exp... | Class II | Aomori Olympus Co., Ltd. |
| Jul 27, 2023 | Olympus Distal Attachment (in Olympus Disposable EMR Kit)- Designed to be att... | The Distal Attachment contain di-2-ethylhexyl phthalate (DEHP), which exceeds the permissible exp... | Class II | Aomori Olympus Co., Ltd. |
| Jan 4, 2021 | NA-201SX-4021 ASPIRATION NEEDLE VIZISHOT 21G, model no. NA-201SX-4021 - Produ... | 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 23G 5MM, model no. NM-400U-0523 - 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 UP 2.8MMCH 21G 4MM, model no. NM-400L-0421 - Product Usage:... | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial... | Class II | Aomori Olympus Co., Ltd. |
| Jan 4, 2021 | NEEDLEMASTER 4MMx 26G UPPER, model no. NM-610L-0426 - 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 | SD-210U-10 ELECTROSURGICAL SNARE, model no. SD-210U-10 - 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 | NA-411D-1521 ASPIRATION NEEDLE, model no. NA-411D-1521 - 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 | CRESCENT SNARE, model no. SD-221L-25 - Product Usage: Used with endoscopes to... | 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 5MM, model no. NM-400L-0525 - Product Usage:... | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial... | Class II | Aomori Olympus Co., Ltd. |
| Jan 4, 2021 | B-V243Q-A 3-LUMEN EXTRACTION BALLOON V, model no. B-V243Q-A - 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 2MM CH 23G 6MM, model no. NM-401L-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 | NEEDLEMASTER 4MMx 23G LOWER, model no. NM-610U-0423 - 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 | INJECTOR FORCEMAX UP 2MM CH 25G 4MM, model no. NM-401L-0425 - Product Usage: ... | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial... | Class II | Aomori Olympus Co., Ltd. |
| Jan 4, 2021 | NEEDLEMASTER 6MMx 25G UPPER, model no. NM-610L-0625 - 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 | INJECTOR FORCEMAX UP 2.8MMCH 23G 5MM, model no. NM-400L-0523 - Product Usage:... | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial... | Class II | Aomori Olympus Co., Ltd. |
| Jan 4, 2021 | NEEDLEMASTER 1.8MMx 26G LOWER, model no. NM-610U-1826 - Product Usage: Used w... | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial... | Class II | Aomori Olympus Co., Ltd. |
| Jan 4, 2021 | NEEDLEMASTER 6MMx 21G UPPER, model no. NM-610L-0621 - 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 | SD-400U-10 SNAREMASTER PLUS Hot/Cold 10m, model no. SD-400U-10 - Product Usag... | 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 23G 5MM, model no. NM-400U-0523 - 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 4MMx 26G LOWER, model no. NM-610U-0426 - 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 | B7-2C BALLOON CATHETER 13mm dia 2.8; model no. B7-2C - Product Usage: Used wi... | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial... | Class II | Aomori Olympus Co., Ltd. |
| Jan 4, 2021 | NEEDLEMASTER 6MMx 25G LOWER, model no. NM-610U-0625 - 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 | KD-612L ELECTROSURGICAL KNIFE, model no. KD-612L - 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 | NEEDLEMASTER 6MMx 23G UPPER, model no. NM-610L-0623 - 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 | KD-612U ELECTROSURGICAL SNARE, model no. KD-612U - 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 UP 2MM CH 25G 6MM, model no. NM-401L-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 | NEEDLEMASTER 4MMx 21G UPPER, model no. NM-610L-0421 - 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 | NEEDLEMASTER 4MMx 25G UPPER, model no. NM-610L-0425 - 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 | KD-650U ELECTROSURGICAL SNARE, model no. KD-650U - 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 | KD-640L ELECTROSURGICAL SNARE, model no. KD-640L - 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 UP 2MM CH 25G 5MM, model no. NM-401L-0525 - Product Usage: ... | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial... | Class II | Aomori Olympus Co., Ltd. |
| Jan 4, 2021 | NEEDLEMASTER 4MMx 25G LOWER, model no. NM-610U-0425 - 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 | SD-240U-10 ELECTROSURGICAL SNARE, model no. SD-240U-10 - 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-0523 - 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 | CRESCENT SNARE, model no. SD-221U-25 - Product Usage: Used with endoscopes to... | 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 2.5MM, model no. NM-400U-0425 - Product Usage: Us... | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial... | Class II | Aomori Olympus Co., Ltd. |
| Jan 4, 2021 | B-V443Q-A 3-LUMEN EXTRACTION BALLOON V, model no. B-V443Q-A - 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 LOWER 23G 4MM, model no. NM-400U-0423 - 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 | NA-601D-1519 ASPIRATION NEEDLE, model no. NA-601D-1519 - 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 UP 2.8MMCH 23G 5MM, model no. NM-400L-0523 - Product Usage:... | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial... | Class II | Aomori Olympus Co., Ltd. |
| Jan 4, 2021 | MAJ-244 SINGLE USE 30MM REPLACEMENT BASKET, model no. MAJ-244 - Product Usage... | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial... | Class II | Aomori Olympus Co., Ltd. |
| Jan 4, 2021 | NA-411D-1321 ASPIRATION NEEDLE, model no. NA-411D-1321 - 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 4MMx 23G UPPER, model no. NM-610L-0423 - 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 | SD-210U-25 ELECTROSURGICAL SNARE, SD-210U-25 - 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 LOWER 23G 4MM, model no. NM-400U-0423 - 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-400U-15 SNAREMASTER PLUS Hot/Cold 15m, model no. SD-400U-15 - Product Usag... | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial... | Class II | Aomori Olympus Co., Ltd. |
| Jan 4, 2021 | SD-210U-15 ELECTROSURGICAL SNARE, SD-210U-15 - 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 | NA-201SX-4022-C ASPIRATION NEEDLE ViziShot 22G w/o stylet, model no. NA-201SX... | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial... | Class II | Aomori Olympus Co., Ltd. |
| Jan 4, 2021 | NA-201SX-4022-ASPIRATION NEEDLE VIZISHOT 22G, model no. NA-201SX-4022-A - Pro... | 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.