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 368 of 1190

FDA device recalls, page 368 of 1190
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-0575-2020	Class II	Alinity c Carbon Dioxide Reagent Kit, Produced for Abbott by Sekisui Diagnostics P.E.I...	Abbott Medical	KHS	2019-10-23
Z-1929-2020	Class II	EMPOWR Acetabular System, Non-Sterile, Model Numbers 803-15-023 803-15-026 803-15-027 803...	Encore Medical, LP	LPH	2019-10-22
Z-0928-2020	Class II	BIOMERIEUX VIDAS 3, Compact immunoanalyzer with full traceability and automation	bioMerieux, Inc.	JJE	2019-10-22
Z-0586-2020	Class II	Evolution Loading Car and Transfer Carriage- Accessory to the Sterilizer, Steam	STERIS Corporation	FLE	2019-10-22
Z-0604-2020	Class II	Eagle 3000 Sterilizer, small steam sterilizer. Product Usage: The Eagle 3000 Small...	STERIS Corporation	FLE	2019-10-22
Z-0420-2020	Class II	EZ Glide Aortic Cannula, 24 Fr. (8.0mm) x 37.6 cm (14.8") 3/8" (9.5 mm) vented connector...	Edwards Lifesciences LLC	DWF	2019-10-22
Z-1088-2022	Class II	MicroScan WalkAway-96 plus Reconditioned Instrument REF B1018-396R	Siemens Healthcare Diagnostics Inc.	LRG	2019-10-21
Z-1087-2022	Class II	MicroScan WalkAway-40 plus Reconditioned Instrument REF B1018-340R	Siemens Healthcare Diagnostics Inc.	LRG	2019-10-21
Z-1086-2022	Class II	DxM 1096 MicroScan WalkAway Instrument REF B1018-496	Siemens Healthcare Diagnostics Inc.	LRG	2019-10-21
Z-1085-2022	Class II	DxM 1040 MicroScan WalkAway Instrument REF B1018-440	Siemens Healthcare Diagnostics Inc.	LRG	2019-10-21
Z-1084-2022	Class II	MicroScan WalkAway-96 plus Instrument REF B1018-284	Siemens Healthcare Diagnostics Inc.	LRG	2019-10-21
Z-1083-2022	Class II	MicroScan WalkAway-40 plus Instrument REF B1018-283	Siemens Healthcare Diagnostics Inc.	LRG	2019-10-21
Z-0906-2020	Class II	Japan DISP SET, 263J, 205J, HAR - Product Usage: its related accessory components are...	Haemonetics Corporation	CAC	2019-10-21
Z-0905-2020	Class II	Japan DISP SET, 263J, 205J, 208 - Product Usage: its related accessory components are...	Haemonetics Corporation	CAC	2019-10-21
Z-0904-2020	Class II	JAPAN CELL SAVER ELITE SET - 225ML - Product Usage: its related accessory components are...	Haemonetics Corporation	CAC	2019-10-21
Z-0903-2020	Class II	JAPAN CELL SAVER ELITE SET - 125ML - Product Usage: its related accessory components are...	Haemonetics Corporation	CAC	2019-10-21
Z-0902-2020	Class II	JAPAN CS ELITE FASTPACK, 225ML - Product Usage: its related accessory components are...	Haemonetics Corporation	CAC	2019-10-21
Z-0901-2020	Class II	Japan CS Elite FASTPACK DISP. SET - 125ML - Product Usage: its related accessory...	Haemonetics Corporation	CAC	2019-10-21
Z-0900-2020	Class II	JAPAN DISP SET, 261J, 205J, HAR - Product Usage: its related accessory components are...	Haemonetics Corporation	CAC	2019-10-21
Z-0899-2020	Class II	JAPAN DISP SET, 261J, 205J, 208 - Product Usage: its related accessory components are...	Haemonetics Corporation	CAC	2019-10-21
Z-0898-2020	Class II	JAPAN BASIC HI SPEED CS5 SET,LN 263J - Product Usage: its related accessory components...	Haemonetics Corporation	CAC	2019-10-21
Z-0897-2020	Class II	JAPAN LOW VOL(125ML) CS5 SET,LN 261J - Product Usage: its related accessory components...	Haemonetics Corporation	CAC	2019-10-21
Z-0654-2020	Class II	C7000 - CUSA Clarity Ultrasonic Tissue Ablation System	Integra LifeSciences Corporation	LFL	2019-10-21
Z-0653-2020	Class II	C7000 - CUSA Clarity Ultrasonic Tissue Ablation System	Integra LifeSciences Corporation	LFL	2019-10-21
Z-0652-2020	Class II	C7000 - CUSA Clarity Ultrasonic Tissue Ablation System	Integra LifeSciences Corporation	LFL	2019-10-21
Z-0651-2020	Class II	C7000 - CUSA Clarity Ultrasonic Tissue Ablation System	Integra LifeSciences Corporation	LFL	2019-10-21
Z-0650-2020	Class II	C7000 - CUSA Clarity Ultrasonic Tissue Ablation System	Integra LifeSciences Corporation	LFL	2019-10-21
Z-0649-2020	Class II	C7000 - CUSA Clarity Ultrasonic Tissue Ablation System	Integra LifeSciences Corporation	LFL	2019-10-21
Z-0648-2020	Class II	C7000 - CUSA Clarity Ultrasonic Tissue Ablation System	Integra LifeSciences Corporation	LFL	2019-10-21
Z-0647-2020	Class II	C7000 - CUSA Clarity Ultrasonic Tissue Ablation System	Integra LifeSciences Corporation	LFL	2019-10-21
Z-0646-2020	Class II	C7000 - CUSA Clarity Ultrasonic Tissue Ablation System	Integra LifeSciences Corporation	LFL	2019-10-21
Z-0645-2020	Class II	C7000 - CUSA Clarity Ultrasonic Tissue Ablation System	Integra LifeSciences Corporation	LFL	2019-10-21
Z-0644-2020	Class II	C7000 - CUSA Clarity Ultrasonic Tissue Ablation System	Integra LifeSciences Corporation	LFL	2019-10-21
Z-0643-2020	Class II	C7000 - CUSA Clarity Ultrasonic Tissue Ablation System	Integra LifeSciences Corporation	LFL	2019-10-21
Z-0642-2020	Class II	C7000 - CUSA Clarity Ultrasonic Tissue Ablation System	Integra LifeSciences Corporation	LFL	2019-10-21
Z-0641-2020	Class II	C7000 - CUSA Clarity Ultrasonic Tissue Ablation System	Integra LifeSciences Corporation	LFL	2019-10-21
Z-0640-2020	Class II	C7000 - CUSA Clarity Ultrasonic Tissue Ablation System	Integra LifeSciences Corporation	LFL	2019-10-21
Z-0639-2020	Class II	C7000 - CUSA Clarity Ultrasonic Tissue Ablation System	Integra LifeSciences Corporation	LFL	2019-10-21
Z-0638-2020	Class II	C7000 - CUSA Clarity Ultrasonic Tissue Ablation System	Integra LifeSciences Corporation	LFL	2019-10-21
Z-0637-2020	Class II	C7000 - CUSA Clarity Ultrasonic Tissue Ablation System	Integra LifeSciences Corporation	LFL	2019-10-21
Z-0636-2020	Class II	C7000 - CUSA Clarity Ultrasonic Tissue Ablation System	Integra LifeSciences Corporation	LFL	2019-10-21
Z-0635-2020	Class II	C7000 - CUSA Clarity Ultrasonic Tissue Ablation System	Integra LifeSciences Corporation	LFL	2019-10-21
Z-0634-2020	Class II	C7000 - CUSA Clarity Ultrasonic Tissue Ablation System	Integra LifeSciences Corporation	LFL	2019-10-21
Z-0633-2020	Class II	C7000 - CUSA Clarity Ultrasonic Tissue Ablation System	Integra LifeSciences Corporation	LFL	2019-10-21
Z-0632-2020	Class II	C7000 - CUSA Clarity Ultrasonic Tissue Ablation System	Integra LifeSciences Corporation	LFL	2019-10-21
Z-0631-2020	Class II	C7000 - CUSA Clarity Ultrasonic Tissue Ablation System	Integra LifeSciences Corporation	LFL	2019-10-21
Z-0630-2020	Class II	C7000 - CUSA Clarity Ultrasonic Tissue Ablation System	Integra LifeSciences Corporation	LFL	2019-10-21
Z-0629-2020	Class II	C7000 - CUSA Clarity Ultrasonic Tissue Ablation System	Integra LifeSciences Corporation	LFL	2019-10-21
Z-0628-2020	Class II	C7000 - CUSA Clarity Ultrasonic Tissue Ablation System	Integra LifeSciences Corporation	LFL	2019-10-21
Z-0627-2020	Class II	C7000 - CUSA Clarity Ultrasonic Tissue Ablation System	Integra LifeSciences Corporation	LFL	2019-10-21