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.

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DateProductReasonClassFirm
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 INJECTOR FORCEMAX LOWER 23G 6MM 5/BX, model no. NM-400U-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 INJECTOR FORCEMAX UP 2MM CH 23G 3MM, model no. NM-401L-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 5MMx 25G LOWER, model no. NM-610U-0525 - 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 PBD-203-0704 BILIARY STENT, model no. PBD-203-0704 -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 KD-650L ELECTROSURGICAL SNARE, model no. KD-650L - 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 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 B7-2Q BALLOON CATHETER 13MM DIA 3.2, model no. B7-2Q -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 B5-2Q BALLOON CATHETER, Model No. B5-2Q - Product Usage: Used with endoscopes... Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial... Class II Aomori Olympus Co., Ltd.
Jan 4, 2021 K-204 GUIDE SHEATH KIT 2.6MM, model no. K-204 - 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 NA-200H-8022 22G EZSHOT ASPIRATION NEEDLE, model no. NA-200H-8022 - Product U... Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial... Class II Aomori Olympus Co., Ltd.
Jan 4, 2021 SD-240U-25 ELECTROSURGICAL SNARE, model no. SD-240U-25 - 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 PBD-203-0710 BILIARY STENT, model no. PBD-203-0710 -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 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 NEEDLEMASTER 3MMx 26G LOWER, model no. NM-610U-0326 - 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 25G 4MM, model no. NM-400L-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 PBD-203-0707 BILIARY STENT, model no. PBD-203-0707 -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 NA-401D-1521 ASPIRATION NEEDLE, model no. NA-401D-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 KD-655L ELECTROSURGICAL SNARE, model no. KD-655L - 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 LOWER 25G 5MM, model no. NM-400U-0525 - 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 K-201 GUIDE SHEATH KIT 2.0MM, model no. K-201 - 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 B5-2C BALLOON CATHETER 11MM DIA 2.0; Model No. B5-2C - 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 INJECTOR FORCEMAX LOWER 25G 5MM, model no. NM-400U-0525 - 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 4MM, model no. NM-400L-0423 - Product Usage:... Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial... Class II Aomori Olympus Co., Ltd.
Jan 4, 2021 K-201 GUIDE SHEATH Kit 2.0MM, model no. K-201 - 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 NEEDLEMASTER 5MMx 25G UPPER, model no. NM-610L-0525 - 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 PBD-203-0703 BILIARY STENT, model no. PBD-203-0703 - 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 K-203 GUIDE SHEATH KIT 2.6MM, model no. K-203 - 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 SD-240U-15 ELECTROSURGICAL SNARE, model no. SD-240U-15 - 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 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 MAJ-247 SINGLE USE 30MM REPLACEMENT BASKET, model no. MAJ-247 - Product Usage... Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial... Class II Aomori Olympus Co., Ltd.
Jan 4, 2021 KD-620LR ELECTROSURGICAL SNARE, model no. KD-620LR - 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 INJECTOR FORCEMAX SIF 270CM 23G 4MM, model no. NM-400Y-0423 - Product Usage: ... Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial... Class II Aomori Olympus Co., Ltd.
Jan 4, 2021 K-204 GUIDE SHEATH Kit 2.6MM, model no K-204 - 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 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 23G 6MM, model no. NM-400U-0623 - 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 K-203 GUIDE SHEATH Kit 2.6MM, model no. K-203 - 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 NEEDLEMASTER 5MMx 21G UPPER, model no. NM-610L-0521 - 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 6MMx 23G LOWER, model no. NM-610U-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 INJECTOR FORCEMAX SIF 270CM 23G 4MM, model no. NM-400Y-0423 - 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 3MMx 23G LOWER, model no. NM-610L-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 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 NA-201SX-4022-B ASPIRATION NEEDLE ViziShot 22G, model no. NA-201SX-4022-B - P... Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial... Class II Aomori Olympus Co., Ltd.
Jan 4, 2021 KD-655U ELECTROSURGICAL SNARE, model no. KD-655U - 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 NA-401D-1321 ASPIRATION NEEDLE, model no. NA-401D-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 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 INJECTOR FORCEMAX SIF 270CM 23G 4MM, model no. NM-401L-0423 - 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 4MM, model no. NM-400L-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 B-V233P-A 3-LUMEN EXTRACTION BALLOON V, model no. B-V233P-A - Product Usage: ... 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.