Device recalls

Recall records from FDA, newest initiation date first.

Every device recall MDM has ingested. The recall record supplies the product, the reason and the product code; the matching enforcement report supplies the Class I, II or III classification. Where the two have not been joined, the class is left blank rather than assumed.

Data as of 2026-10-15, the FDA export date. FDA medical device recall database

59,486 records, page 305 of 1190

FDA device recalls, page 305 of 1190
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-1150-2021	Class II	Infusion Pump	Baxter Healthcare Corporation	FRN	2021-01-06
Z-1385-2022	Class III	HAMILTON-H900 Humidifier, Models: 950001, 950004	Hamilton Medical AG	BTT	2021-01-05
Z-0940-2021	Class III	Nucleic acid-based in vitro diagnostic devices for the detection of 2019-novel...	Biomeme, Inc.	QJR	2021-01-05
Z-1108-2021	Class II	Cascade Abrazo aPTT Test Card - Product Usage: are to be used with the Cascade Abrazo...	Helena Laboratories, Corp.	GFO	2021-01-05
Z-0953-2021	Class II	Ethicon Dermabond Advanced Topical Skin Adhesive-topical skin adhesive to hold closed...	Ethicon, Inc	MPN	2021-01-04
Z-1071-2021	Class II	CRESCENT SNARE, model no. SD-221U-25 - Product Usage: Used with endoscopes to...	AOMORI OLYMPUS CO., Ltd. Kuroishi Site	GEI	2021-01-04
Z-1070-2021	Class II	CRESCENT SNARE, model no. SD-221L-25 - Product Usage: Used with endoscopes to...	AOMORI OLYMPUS CO., Ltd. Kuroishi Site	GEI	2021-01-04
Z-1069-2021	Class II	NA-200H-8022 22G EZSHOT ASPIRATION NEEDLE, model no. NA-200H-8022 - Product Usage: Used...	AOMORI OLYMPUS CO., Ltd. Kuroishi Site	FCG	2021-01-04
Z-1068-2021	Class II	MAJ-247 SINGLE USE 30MM REPLACEMENT BASKET, model no. MAJ-247 - Product Usage...	AOMORI OLYMPUS CO., Ltd. Kuroishi Site	LQC	2021-01-04
Z-1067-2021	Class II	MAJ-244 SINGLE USE 30MM REPLACEMENT BASKET, model no. MAJ-244 - Product Usage...	AOMORI OLYMPUS CO., Ltd. Kuroishi Site	LQC	2021-01-04
Z-1066-2021	Class II	PBD-203-0710 BILIARY STENT, model no. PBD-203-0710 -Product Usage: Used with endoscopes...	AOMORI OLYMPUS CO., Ltd. Kuroishi Site	FGE	2021-01-04
Z-1065-2021	Class II	PBD-203-0707 BILIARY STENT, model no. PBD-203-0707 -Product Usage: Used with endoscopes...	AOMORI OLYMPUS CO., Ltd. Kuroishi Site	FGE	2021-01-04
Z-1064-2021	Class II	PBD-203-0704 BILIARY STENT, model no. PBD-203-0704 -Product Usage: Used with endoscopes...	AOMORI OLYMPUS CO., Ltd. Kuroishi Site	FGE	2021-01-04
Z-1063-2021	Class II	PBD-203-0703 BILIARY STENT, model no. PBD-203-0703 - Product Usage: Used with endoscopes...	AOMORI OLYMPUS CO., Ltd. Kuroishi Site	FGE	2021-01-04
Z-1062-2021	Class II	NA-201SX-4022-C ASPIRATION NEEDLE ViziShot 22G w/o stylet, model no. NA-201SX-4022-C...	AOMORI OLYMPUS CO., Ltd. Kuroishi Site	FCG	2021-01-04
Z-1061-2021	Class II	NA-201SX-4022-B ASPIRATION NEEDLE ViziShot 22G, model no. NA-201SX-4022-B - Product...	AOMORI OLYMPUS CO., Ltd. Kuroishi Site	FCG	2021-01-04
Z-1060-2021	Class II	NA-201SX-4022-ASPIRATION NEEDLE VIZISHOT 22G, model no. NA-201SX-4022-A - Product Usage...	AOMORI OLYMPUS CO., Ltd. Kuroishi Site	FCG	2021-01-04
Z-1059-2021	Class II	NA-201SX-4021 ASPIRATION NEEDLE VIZISHOT 21G, model no. NA-201SX-4021 - Product Usage...	AOMORI OLYMPUS CO., Ltd. Kuroishi Site	FCG	2021-01-04
Z-1058-2021	Class II	NA-601D-1519 ASPIRATION NEEDLE, model no. NA-601D-1519 - Product Usage: Used with...	AOMORI OLYMPUS CO., Ltd. Kuroishi Site	GAA	2021-01-04
Z-1057-2021	Class II	NA-411D-1521 ASPIRATION NEEDLE, model no. NA-411D-1521 - Product Usage: Used with...	AOMORI OLYMPUS CO., Ltd. Kuroishi Site	GAA	2021-01-04
Z-1056-2021	Class II	NA-411D-1321 ASPIRATION NEEDLE, model no. NA-411D-1321 - Product Usage: Used with...	AOMORI OLYMPUS CO., Ltd. Kuroishi Site	GAA	2021-01-04
Z-1055-2021	Class II	NA-401D-1521 ASPIRATION NEEDLE, model no. NA-401D-1521 - Product Usage: Used with...	AOMORI OLYMPUS CO., Ltd. Kuroishi Site	GAA	2021-01-04
Z-1054-2021	Class II	NA-401D-1321 ASPIRATION NEEDLE, model no. NA-401D-1321 - Product Usage: Used with...	AOMORI OLYMPUS CO., Ltd. Kuroishi Site	GAA	2021-01-04
Z-1053-2021	Class II	K-204 GUIDE SHEATH KIT 2.6MM, model no. K-204 - Product Usage: Used with endoscopes to...	AOMORI OLYMPUS CO., Ltd. Kuroishi Site	EOQ	2021-01-04
Z-1052-2021	Class II	K-203 GUIDE SHEATH KIT 2.6MM, model no. K-203 - Product Usage: Used with endoscopes to...	AOMORI OLYMPUS CO., Ltd. Kuroishi Site	EOQ	2021-01-04
Z-1051-2021	Class II	K-202 GUIDE SHEATH KIT 2.0MM, model no. K-202 - Product Usage: Used with endoscopes to...	AOMORI OLYMPUS CO., Ltd. Kuroishi Site	EOQ	2021-01-04
Z-1050-2021	Class II	K-201 GUIDE SHEATH KIT 2.0MM, model no. K-201 - Product Usage: Used with endoscopes to...	AOMORI OLYMPUS CO., Ltd. Kuroishi Site	EOQ	2021-01-04
Z-1049-2021	Class II	NEEDLEMASTER 1.8MMx 26G LOWER, model no. NM-610U-1826 - Product Usage: Used with...	AOMORI OLYMPUS CO., Ltd. Kuroishi Site	FBK	2021-01-04
Z-1048-2021	Class II	NEEDLEMASTER 6MMx 25G LOWER, model no. NM-610U-0625 - Product Usage: Used with endoscopes...	AOMORI OLYMPUS CO., Ltd. Kuroishi Site	FBK	2021-01-04
Z-1047-2021	Class II	NEEDLEMASTER 6MMx 23G LOWER, model no. NM-610U-0623 - Product Usage: Used with endoscopes...	AOMORI OLYMPUS CO., Ltd. Kuroishi Site	FBK	2021-01-04
Z-1046-2021	Class II	NEEDLEMASTER 5MMx 25G LOWER, model no. NM-610U-0525 - Product Usage: Used with endoscopes...	AOMORI OLYMPUS CO., Ltd. Kuroishi Site	FBK	2021-01-04
Z-1045-2021	Class II	NEEDLEMASTER 3MMx 23G LOWER, model no. NM-610U-0523 - Product Usage: Used with endoscopes...	AOMORI OLYMPUS CO., Ltd. Kuroishi Site	FBK	2021-01-04
Z-1044-2021	Class II	NEEDLEMASTER 4MMx 26G LOWER, model no. NM-610U-0426 - Product Usage: Used with endoscopes...	AOMORI OLYMPUS CO., Ltd. Kuroishi Site	FBK	2021-01-04
Z-1043-2021	Class II	NEEDLEMASTER 4MMx 25G LOWER, model no. NM-610U-0425 - Product Usage: Used with endoscopes...	AOMORI OLYMPUS CO., Ltd. Kuroishi Site	FBK	2021-01-04
Z-1042-2021	Class II	NEEDLEMASTER 4MMx 23G LOWER, model no. NM-610U-0423 - Product Usage: Used with endoscopes...	AOMORI OLYMPUS CO., Ltd. Kuroishi Site	FBK	2021-01-04
Z-1041-2021	Class II	NEEDLEMASTER 3MMx 26G LOWER, model no. NM-610U-0326 - Product Usage: Used with endoscopes...	AOMORI OLYMPUS CO., Ltd. Kuroishi Site	FBK	2021-01-04
Z-1040-2021	Class II	NEEDLEMASTER 3MMx 23G LOWER, model no. NM-610U-0323 - Product Usage: Used with endoscopes...	AOMORI OLYMPUS CO., Ltd. Kuroishi Site	FBK	2021-01-04
Z-1039-2021	Class II	NEEDLEMASTER 6MMx 25G UPPER, model no. NM-610L-0625 - Product Usage: Used with endoscopes...	AOMORI OLYMPUS CO., Ltd. Kuroishi Site	FBK	2021-01-04
Z-1038-2021	Class II	NEEDLEMASTER 6MMx 23G UPPER, model no. NM-610L-0623 - Product Usage: Used with endoscopes...	AOMORI OLYMPUS CO., Ltd. Kuroishi Site	FBK	2021-01-04
Z-1037-2021	Class II	NEEDLEMASTER 6MMx 21G UPPER, model no. NM-610L-0621 - Product Usage: Used with endoscopes...	AOMORI OLYMPUS CO., Ltd. Kuroishi Site	FBK	2021-01-04
Z-1036-2021	Class II	NEEDLEMASTER 5MMx 25G UPPER, model no. NM-610L-0525 - Product Usage: Used with endoscopes...	AOMORI OLYMPUS CO., Ltd. Kuroishi Site	FBK	2021-01-04
Z-1035-2021	Class II	NEEDLEMASTER 3MMx 23G LOWER, model no. NM-610L-0523 - Product Usage: Used with endoscopes...	AOMORI OLYMPUS CO., Ltd. Kuroishi Site	FBK	2021-01-04
Z-1034-2021	Class II	NEEDLEMASTER 5MMx 21G UPPER, model no. NM-610L-0521 - Product Usage: Used with endoscopes...	AOMORI OLYMPUS CO., Ltd. Kuroishi Site	FBK	2021-01-04
Z-1033-2021	Class II	NEEDLEMASTER 4MMx 26G UPPER, model no. NM-610L-0426 - Product Usage: Used with endoscopes...	AOMORI OLYMPUS CO., Ltd. Kuroishi Site	FBK	2021-01-04
Z-1032-2021	Class II	NEEDLEMASTER 4MMx 25G UPPER, model no. NM-610L-0425 - Product Usage: Used with endoscopes...	AOMORI OLYMPUS CO., Ltd. Kuroishi Site	FBK	2021-01-04
Z-1031-2021	Class II	NEEDLEMASTER 4MMx 23G UPPER, model no. NM-610L-0423 - Product Usage: Used with endoscopes...	AOMORI OLYMPUS CO., Ltd. Kuroishi Site	FBK	2021-01-04
Z-1030-2021	Class II	NEEDLEMASTER 4MMx 21G UPPER, model no. NM-610L-0421 - Product Usage: Used with endoscopes...	AOMORI OLYMPUS CO., Ltd. Kuroishi Site	FBK	2021-01-04
Z-1029-2021	Class II	INJECTOR FORCEMAX UP 2MM CH 25G 6MM, model no. NM-401L-0625 - Product Usage: Used with...	AOMORI OLYMPUS CO., Ltd. Kuroishi Site	FGX	2021-01-04
Z-1028-2021	Class II	INJECTOR FORCEMAX UP 2MM CH 23G 6MM, model no. NM-401L-0623 - Product Usage: Used with...	AOMORI OLYMPUS CO., Ltd. Kuroishi Site	FGX	2021-01-04
Z-1027-2021	Class II	INJECTOR FORCEMAX UP 2MM CH 25G 5MM, model no. NM-401L-0525 - Product Usage: Used with...	AOMORI OLYMPUS CO., Ltd. Kuroishi Site	FGX	2021-01-04