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 860 of 1190

FDA device recalls, page 860 of 1190
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-1250-2011		Xeleris Processing and Review Workstation 1.0, 1.1, 2.0, 3.0 The display, processing...	GE Healthcare	LLZ	2011-01-12
Z-1673-2011		Ovation Hip Stem, REF 201-0104, Offset Stem Inserter Neutral, Non-Sterile, Ortho...	Ortho Development Corp.	LZO	2011-01-11
Z-1672-2011		Ovation Hip Stem, REF 201-0103, Offset Stem Inserter LT, Non-Sterile, Ortho Development...	Ortho Development Corp.	LZO	2011-01-11
Z-1671-2011		Ovation Hip Stem, REF 201-0102, Offset Stem Inserter RT, Non-Sterile, Ortho Development...	Ortho Development Corp.	LZO	2011-01-11
Z-1525-2011		TI ANCHOR 2.5MM W / 2-0 SUTURE, G-FORCE (R) SUTURE ANCHOR, Tissue Anchor, REF 86TA-2520...	Wright Medical Technology Inc	MBI	2011-01-11
Z-1524-2011		TI ANCHOR 1.9MM W / 2-0 SUTURE, G-FORCE SUTURE ANCHOR, Tissue Anchor, REF 86TA-1920, Rx...	Wright Medical Technology Inc	MBI	2011-01-11
Z-1670-2011		Ovation Hip Stem, REF 201-0002, Hip Stem Inserter, Non-Sterile, Ortho Development...	Ortho Development Corp.	LZO	2011-01-11
Z-1572-2011		MOSAIQ Oncology Information System Intended Use : Electronic Patient Records Management	Siemens Medical Solutions USA, Inc.	IYE	2011-01-11
Z-1423-2011		HomeFill Oxygen Compressor IOH200 Homefill, The serial numbers are as follows...	Invacare GmbH	CAW	2011-01-11
Z-2326-2017	Class II	Video Naso pharyngo Laryngoscopes	PENTAX of America, Inc.	EOQ	2011-01-11
Z-2325-2017	Class II	Video Cytoscopes	PENTAX of America, Inc.	EOQ	2011-01-11
Z-2324-2017	Class II	Video Bronchoscope	PENTAX of America, Inc.	EOQ	2011-01-11
Z-1848-2014	Class II	SteriGear Urinary Drain Bag with Fig Leaf Cover, 2000 ml, REF 10270, The Fig Leaf...	SteriGear, LLC	FCN	2011-01-11
Z-2197-2011		Manta Ray" Anterior Cervical Plate (ACP) System, Intended use: The Manta Ray ACP System...	Integra LifeSciences Corporation	KWQ	2011-01-10
Z-1521-2011		Vari Lase WireFiber Laser Fiber, RED 7137, Rx ONLY, Sterile EO, Vascular Solutions Inc...	Vascular Solutions LLC	GEX	2011-01-10
Z-1401-2011		MAGNETOM Verio Nuclear magnetic resonance imaging	Siemens Medical Solutions USA, Inc.	LNH	2011-01-10
Z-2052-2011		Boston Scientific's LATITUDE Patient Management System: LATITUDE 6.1 Patient Management...	Boston Scientific Corporation	LWS	2011-01-10
Z-1230-2011		Bipolar cord for use with the VirtuoSaph Endoscopic Vein Harvesting System, MCBICORD1...	Terumo Cardiovascular Systems Corporation	GCJ	2011-01-10
Z-1378-2011		InfusO.R. Infusion Pump, an Rx syringe infusion pump; Baxter Healthcare Corporation...	Baxter Healthcare Corporation	FRN	2011-01-10
Z-1224-2011		Pump in Style Advanced (PNSA)Breast Pump; a daily use, double pump, electric powered...	Medela AG	HGX	2011-01-10
Z-0524-2012		Heritage Labs Blood/Urine Collection Kit, Product A1100, packed in bags in bulk, 25...	Heritage Labs International LLC	JKA	2011-01-09
Z-0581-2012		Principal Combo Test Pak, Product K8700, each kit packed in a bag or envelope and...	Heritage Labs International LLC	LCP	2011-01-09
Z-0580-2012		Appraise DBS Test Pak/HW-Kronos KROJI, Product K8603, each kit packed in a bag or...	Heritage Labs International LLC	LCP	2011-01-09
Z-0579-2012		Biometric Combo Test Kit, Product K8500, each kit packed in a bag or envelope and...	Heritage Labs International LLC	JKA	2011-01-09
Z-0578-2012		Heritage Labs University of Michigan Clinical Kit, Product K8311, each kit packed in a...	Heritage Labs International LLC	LCP	2011-01-09
Z-0577-2012		University of Mannheim DBS Collection Kit, Product K8308, each kit packed in a bag or...	Heritage Labs International LLC	LCP	2011-01-09
Z-0576-2012		Principal Waist Circumference DBS Collection Kit, Product K8307, each kit packed in a...	Heritage Labs International LLC	LCP	2011-01-09
Z-0575-2012		University of Michigan DBS Collection Kit, Product K8306, each kit packed in a bag or...	Heritage Labs International LLC	LCP	2011-01-09
Z-0574-2012		H & W Principal DBS Collection Kit, Product K8305, each kit packed in a bag or envelope...	Heritage Labs International LLC	LCP	2011-01-09
Z-0573-2012		Heritage Labs Appraise DBS Bio Disk Test, Product K8304-QNS, each kit packed in a bag or...	Heritage Labs International LLC	LCP	2011-01-09
Z-0572-2012		HooperHolmes Health & Wellness, Product K8303, each kit packed in an envelope and...	Heritage Labs International LLC	LCP	2011-01-09
Z-0571-2012		Appraise DBS Kit, Product K8302, each kit packed in a bag or envelope. (This kit was...	Heritage Labs International LLC	LCP	2011-01-09
Z-0570-2012		Appraise DBS Test Pak/Moore Medical LLC, Product K8301, each kit packed in a bag or...	Heritage Labs International LLC	LCP	2011-01-09
Z-0569-2012		Appraise/Heritage Combo A1C & Blood Test Kit, Product K8300, each kit packed in a bag or...	Heritage Labs International LLC	LCP	2011-01-09
Z-0568-2012		Appraise/Heritage Combo Kit, Product K8100, each kit packed in a bag or envelope and...	Heritage Labs International LLC	LCP	2011-01-09
Z-0567-2012		NDI/Life Extension Microtainer Blood Kit, Product K7625, each kit packed in a bag or...	Heritage Labs International LLC	KDT	2011-01-09
Z-0566-2012		NDI Combo Test Pak Omega 3, Product K7618, each kit packed in a bag or envelope and...	Heritage Labs International LLC	KDT	2011-01-09
Z-0565-2012		NDI Combo Test Pak Omega 3, Product K7616, each kit packed in a bag or envelope and...	Heritage Labs International LLC	KDT	2011-01-09
Z-0564-2012		Appraise A1c Retail Kit, Product K7615, each kit packed in a box and contains 1 Triad...	Heritage Labs International LLC	LCP	2011-01-09
Z-0563-2012		Heritage Labs Nutrasource NDI (USA) DBS Kit, Product K7610, each kit packed in a bag or...	Heritage Labs International LLC	KDT	2011-01-09
Z-0562-2012		Heritage Labs Appraise A1c Diabetes Home Test , Product K7609, 24 kits/shipping carton...	Heritage Labs International LLC	LCP	2011-01-09
Z-0561-2012		Heritage Labs Appraise Diabetes A1c Test , 24 kits/shipping carton (Product K7604), each...	Heritage Labs International LLC	LCP	2011-01-09
Z-0560-2012		Reli On Hemoglobin A1c Test (Replacement), Product K7603, each kit packed in a bag or...	Heritage Labs International LLC	LCP	2011-01-09
Z-0559-2012		Heritage Labs Appraise Diabetes A1c Test , 12 kits/shipping carton (Product K7602), each...	Heritage Labs International LLC	LCP	2011-01-09
Z-0558-2012		Appraise Hemoglobin A1c Test , Product K7600, each kit packed in a bag or envelope and...	Heritage Labs International LLC	LCP	2011-01-09
Z-0557-2012		Appraise A1C Test Pak Kit (Carolina Care Plan), Product K7400, each kit packed in a bag...	Heritage Labs International LLC	LCP	2011-01-09
Z-0556-2012		Appraise A1C Test Pak Kit (Alere), Product K7300, each kit packed in a bag or envelope...	Heritage Labs International LLC	LCP	2011-01-09
Z-0555-2012		Appraise A1C Test Pak Kit (IBM Care Advantage), Product K7200, each kit packed in a bag...	Heritage Labs International LLC	LCP	2011-01-09
Z-0554-2012		Appraise A1C Test Pak Kit (Consumers Life Insurance Company), Product K7100, each kit...	Heritage Labs International LLC	LCP	2011-01-09
Z-0553-2012		Appraise A1C (Retail) Collection Kit, Product K7050, each kit packed in a bag or...	Heritage Labs International LLC	LCP	2011-01-09