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 2026-10-19, the FDA export date. FDA medical device recall database

59,528 records, page 746 of 1191

FDA device recalls, page 746 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-1759-2013	Class I	AlboGraft Knitted with Collagen, Bifurcate 20x10Catalog Number: AMC2010 AlboGraft...	LeMaitre Vascular Inc.	MAL	2013-06-17
Z-1758-2013	Class I	AlboGraft Knitted with Collagen, Bifurcate 18x10 Catalog Number: AMC1810 AlboGraft...	LeMaitre Vascular Inc.	MAL	2013-06-17
Z-1757-2013	Class I	AlboGraft Knitted with Collagen, Bifurcate 18x09 Catalog Number: AMC1809 AlboGraft...	LeMaitre Vascular Inc.	MAL	2013-06-17
Z-1756-2013	Class I	Albo Graft Knitted with Collagen, Bifurcate 16x08 Catalog Number: AMC1608 AlboGraft...	LeMaitre Vascular Inc.	MAL	2013-06-17
Z-1755-2013	Class I	AlboGraft Knitted with Collagen, Straight 15x06 Catalog Number: AMC1506 AlboGraft...	LeMaitre Vascular Inc.	MAL	2013-06-17
Z-1754-2013	Class I	AlboGraft Knitted with Collagen, Bifurcate 14x08 Catalog Number: AMC1408 AlboGraft...	LeMaitre Vascular Inc.	MAL	2013-06-17
Z-0986-2015	Class II	The SurgiCounter Charging Cradle Product Usage: SurgiCounter Charging Cradles are...	Stryker Corp.	LWH	2013-06-16
Z-2616-2014	Class II	Streamline MIS Spinal Fixation System Fixed Rod Holder NON STERILE, Rx only The...	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)	NKB	2013-06-14
Z-1921-2013	Class II	bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2...	bioMerieux, Inc.	LTW	2013-06-14
Z-1920-2013	Class II	bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2...	bioMerieux, Inc.	LTW	2013-06-14
Z-1919-2013	Class II	bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2...	bioMerieux, Inc.	LTW	2013-06-14
Z-1918-2013	Class II	bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2...	bioMerieux, Inc.	LTW	2013-06-14
Z-1917-2013	Class II	bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2...	bioMerieux, Inc.	LTW	2013-06-14
Z-1916-2013	Class II	bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2...	bioMerieux, Inc.	LTW	2013-06-14
Z-1915-2013	Class II	bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2...	bioMerieux, Inc.	LTW	2013-06-14
Z-1914-2013	Class II	bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2...	bioMerieux, Inc.	LTW	2013-06-14
Z-1913-2013	Class II	bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2...	bioMerieux, Inc.	LTW	2013-06-14
Z-1912-2013	Class II	bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2...	bioMerieux, Inc.	LTW	2013-06-14
Z-1911-2013	Class II	bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2...	bioMerieux, Inc.	LTW	2013-06-14
Z-1910-2013	Class II	bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2...	bioMerieux, Inc.	LTW	2013-06-14
Z-1909-2013	Class II	bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2...	bioMerieux, Inc.	LTW	2013-06-14
Z-1908-2013	Class II	bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2...	bioMerieux, Inc.	LTW	2013-06-14
Z-1966-2013	Class II	Medtronic Affinity Pediatric Arterial Filter, model number S4014, sterilized using...	Medtronic, Inc.	DTM	2013-06-14
Z-1907-2013	Class II	bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2...	bioMerieux, Inc.	LTW	2013-06-14
Z-1793-2013	Class I	Optima NM/CT 640 Product Usage: The GE Optima NM/CT 640 system is intended for...	GE Healthcare	KPS	2013-06-13
Z-1792-2013	Class I	Discovery NM/CT 670 dual detector free-geometry integrated nuclear imaging system...	GE Healthcare	KPS	2013-06-13
Z-1791-2013	Class I	Discovery NM 630, dual detector free-geometry integrated nuclear imaging system...	GE Healthcare	KPS	2013-06-13
Z-1790-2013	Class I	Brivo NM615, is an all-purpose, single detector integrated nuclear imaging system...	GE Healthcare	KPS	2013-06-13
Z-1812-2013	Class II	BD Affirm VPIII Microbial Identification Tests, packaged in kits, 120 test\kit, Catalog #...	Becton Dickinson & Co	MLA	2013-06-13
Z-1789-2013	Class I	Elscint APEX Helix, dual-head, multi-purpose, Slip-Ring, digital gamma camera Product...	GE Healthcare	KPS	2013-06-13
Z-1788-2013	Class I	GE Healthcare Varicam/VG and VG Hawkeye devices Product Usage: The intended use of the...	GE Healthcare	KPS	2013-06-13
Z-1787-2013	Class I	GE Healthcare Infinia Hawkeye 4 Option For Dual-Head Variable Angle Gamma Camera, Hawkeye...	GE Healthcare	KPS	2013-06-13
Z-0328-2014	Class II	VITROS Chemistry Products URIC Slides packaged as 300 slides/pack catalog number...	Ortho-Clinical Diagnostics, Inc.	KNK	2013-06-12
Z-0327-2014	Class II	VITROS Chemistry Products UPRO Slides packaged as 90 slides/pack catalog number...	Ortho-Clinical Diagnostics, Inc.	JGP	2013-06-12
Z-0326-2014	Class II	VITROS Chemistry Products TRIG Slides packaged as 300 slides/pack catalog number 1336544...	Ortho-Clinical Diagnostics, Inc.	KLS	2013-06-12
Z-0325-2014	Class II	VITROS Chemistry Products THEO Slides packaged as 300 slides/pack catalog number 8301764...	Ortho-Clinical Diagnostics, Inc.	KLS	2013-06-12
Z-0324-2014	Class II	VITROS Chemistry Products TBIL Slides packaged as 300 slides/pack catalog number...	Ortho-Clinical Diagnostics, Inc.	CIG	2013-06-12
Z-0323-2014	Class II	VITROS Chemistry Products SALI Slides packaged as 90 slides/pack catalog number...	Ortho-Clinical Diagnostics, Inc.	DKJ	2013-06-12
Z-0322-2014	Class II	VITROS Chemistry Products PROT Slides packaged as 90 slides/pack catalog number...	Ortho-Clinical Diagnostics, Inc.	CEK	2013-06-12
Z-0321-2014	Class II	VITROS Chemistry Products PHYT Slides packaged as 90 slides/pack catalog number...	Ortho-Clinical Diagnostics, Inc.	DIP	2013-06-12
Z-0320-2014	Class II	VITROS Chemistry Products PHOS Slides packaged as 300 slides/pack catalog number...	Ortho-Clinical Diagnostics, Inc.	CEO	2013-06-12
Z-0319-2014	Class II	VITROS Chemistry Products PHBR Slides packaged as 90 slides/pack catalog number...	Ortho-Clinical Diagnostics, Inc.	DLZ	2013-06-12
Z-0318-2014	Class II	VITROS Chemistry Products Mg Slides packaged as 300 slides/pack catalog number 8255093...	Ortho-Clinical Diagnostics, Inc.	JGJ	2013-06-12
Z-0317-2014	Class II	VITROS Chemistry Products LIPA Slides packaged as 300 slides/pack catalog number 1668409...	Ortho-Clinical Diagnostics, Inc.	CHI	2013-06-12
Z-0316-2014	Class II	VITROS Chemistry Products Li Slides packaged as 300 slides/pack catalog number 8318925...	Ortho-Clinical Diagnostics, Inc.	JIH	2013-06-12
Z-0315-2014	Class II	VITROS Chemistry Products LAC Slides packaged as 300 slides/pack catalog number 8433880...	Ortho-Clinical Diagnostics, Inc.	CFJ	2013-06-12
Z-0314-2014	Class II	VITROS Chemistry Products GLU Slides packaged as 300 slides/pack catalog number...	Ortho-Clinical Diagnostics, Inc.	CGA	2013-06-12
Z-0313-2014	Class II	VITROS Chemistry Products Fe Slides packaged as 300 slides/pack catalog number 1515808...	Ortho-Clinical Diagnostics, Inc.	JIY	2013-06-12
Z-0312-2014	Class II	VITROS Chemistry Products ECO2 Slides packaged as 300 slides/pack catalog number...	Ortho-Clinical Diagnostics, Inc.	KHS	2013-06-12
Z-0311-2014	Class II	VITROS Chemistry Products dHDL Slides packaged as 300 slides/pack catalog number...	Ortho-Clinical Diagnostics, Inc.	LBS	2013-06-12