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 880 of 1190

FDA device recalls, page 880 of 1190
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-0487-2011		HeartStart FR2+ AED with ECG Display, Model 989803148601. This product is G2005 Update...	Philips North America LLC	MKJ	2010-09-22
Z-0486-2011		HeartStart FR2+ AED with Text Display (No ECG), Model 3841, Laerdal brand, no...	Philips North America LLC	MKJ	2010-09-22
Z-0485-2011		HeartStart FR2+ AED with ECG Display, Model 3840, Laerdal brand, configurable manual...	Philips North America LLC	MKJ	2010-09-22
Z-0484-2011		HeartStart FR2+ AED with Text Display (No ECG), Model M3861, Philips brand, no...	Philips North America LLC	MKJ	2010-09-22
Z-0165-2011		LeMaitre Vascular AnastoClip GC Vessel Closure System-Large Size Models: 4007-03 Large...	LeMaitre Vascular Inc.	HBT	2010-09-22
Z-0164-2011		LeMaitre Vascular AnastoClip GC Vessel Closure System-Medium Size Models: 4007-02 Medium...	LeMaitre Vascular Inc.	HBT	2010-09-22
Z-0483-2011		HeartStart FR2+ AED with ECG Display, Model M3860, Philips brand, configurable manual...	Philips North America LLC	MKJ	2010-09-22
Z-1951-2013	Class II	ISE Electrolyte Reference reagent (for Synchron LX Systems and UniCel DxC 600/800...	Siemens Healthcare Diagnostics Inc.	CEM	2010-09-22
Z-2406-2011		Newport HT70 Ventilator. Model #HT70, The Newport HT70 ventilator is intended to...	Newport Medical Instruments, Inc.	CBK	2010-09-20
Z-0167-2011		Captus 3000 Thyroid Uptake System with Portable Stand option. Capintec item number...	Mirion Technologies (Capintec), Inc.	KPT	2010-09-20
Z-0598-2011		Military Kit Portable Clinical Analyzer; Abbott Point of Care, Princeton, NJ 08540 Model...	Abbott Medical	CGA	2010-09-20
Z-0597-2011		i-STAT Portable Clinical Analyzer; Abbott Point of Care, Princeton, NJ 08540 Model 200...	Abbott Medical	CGA	2010-09-20
Z-0596-2011		Military Kit i-STAT1; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree...	Abbott Medical	CHL	2010-09-20
Z-0595-2011		i-STAT1 Abaxis Analyzer; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37...	Abbott Medical	CHL	2010-09-20
Z-0594-2011		FUSO Analyzer 300F Abbott Point of Care, Princeton, NJ 08540 Model 200. the 37 degree 37...	Abbott Medical	CHL	2010-09-20
Z-0593-2011		i-STAT Analyzer; Abbott Point of Care, Princeton, NJ 08540 Model 200. the 37 degree 37...	Abbott Medical	CHL	2010-09-20
Z-0143-2011		The label (which is affixed to ScanPoint Communications Cradle) states: "...VERATHON...	Verathon Inc.	ITX	2010-09-20
Z-2578-2011		XiO Radiation treatment Planning System, XiO Release 4.2.0 and above Usage: Used to...	Elekta Limited	MUJ	2010-09-17
Z-1893-2011		*REF VP6528Qty 1Articulating Arm, Secondary Flat PanelRX Only**See...	Linvatec Corporation	KQM	2010-09-17
Z-0163-2011		Leksell Gamma Knife Perfexion with EXTEND Frame System, manufactured by Electa Instrument...	Elekta Limited	IWB	2010-09-17
Z-0356-2011		Baxter CLEARLINK System, Non-DEHP Catheter Extension Set Kit; 8.2" (21.0 cm), Vol. 0.57...	Baxter Healthcare Corporation	LBJ	2010-09-17
Z-0355-2011		Baxter INTERLINK System, Non-DEHP Catheter Extension Set Kit; 7.1" (18.0 cm), Vol. 0.85...	Baxter Healthcare Corporation	LBJ	2010-09-17
Z-0354-2011		Baxter CLEARLINK System, Non-DEHP Catheter Extension Set Kit; 7.7" (20.0 cm), Vol. 1.10...	Baxter Healthcare Corporation	LBJ	2010-09-17
Z-0353-2011		Baxter Catheter Stabilization Device; 1 VITAL-HOLD Medium Catheter Stabilization Device...	Baxter Healthcare Corporation	LBJ	2010-09-17
Z-0352-2011		Baxter V-Link Luer Activated Device with VitalShield Protective Coating Non-DEHP Catheter...	Baxter Healthcare Corporation	LBJ	2010-09-17
Z-3036-2011		Product is the Ultraview Spacelabs Compact monitor, models 91367, 91369, and 91370, with...	GE Healthcare	MHX	2010-09-17
Z-0937-2011		Welch Allyn PIC 50 Portable Intensive Care System. Model 971081 series. Designed for...	Welch Allyn Protocol, Inc.	DRO	2010-09-17
Z-0073-2011		ActiveLife One-Piece Drainable Pouch with Stomahesive Skin Barrier; 1 1/4 in., 32mm; Made...	ConvaTec Limited	EZQ	2010-09-17
Z-0351-2011		Baxter V-Link Luer Activated Device with Vitalshield Protective Coating Non-DEHP Catheter...	Baxter Healthcare Corporation	LBJ	2010-09-17
Z-1877-2011		CYTO-STAT tetraCHROME CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5, Part Number: 6607073. Allows...	Siemens Healthcare Diagnostics Inc.	GKZ	2010-09-16
Z-1876-2011		CYTO-STAT tetraCHROME" CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5, Part Number: 6607013 Allows...	Siemens Healthcare Diagnostics Inc.	GKZ	2010-09-16
Z-0418-2011		LAP-BAND Adjustable Gastric Band System; Product codes: B-2105 (ACCSS PRT II KIT (0-10CC)...	Allergan	LTI	2010-09-16
Z-0285-2011		VITEK 2 Gram Negative Susceptibility Card, AST-N107, REF 22 265, For In Vitro Diagnostic...	bioMerieux, Inc.	LON	2010-09-16
Z-0284-2011		VITEK 2 Gram Negative Susceptibility Card, AST-GN44, REF 410 805, For In Vitro...	bioMerieux, Inc.	LON	2010-09-16
Z-0283-2011		VITEK 2 Gram Negative Susceptibility Card, AST-GN43, REF 410 759, For In Vitro...	bioMerieux, Inc.	LON	2010-09-16
Z-0282-2011		VITEK 2 Gram Negative Susceptibility Card, AST-GN40, REF 410 756, For In Vitro...	bioMerieux, Inc.	LON	2010-09-16
Z-0281-2011		VITEK 2 Gram Negative Susceptibility Card, AST-N182, REF 410 804, For In Vitro...	bioMerieux, Inc.	LON	2010-09-16
Z-0280-2011		VITEK 2 Gram Negative Susceptibility Card, AST-N181, REF 410 803, For In Vitro...	bioMerieux, Inc.	LON	2010-09-16
Z-0279-2011		VITEK 2 Gram Negative Susceptibility Card, AST-N180, REF 410 771, For In Vitro...	bioMerieux, Inc.	LON	2010-09-16
Z-0278-2011		VITEK 2 Gram Negative Susceptibility Card, AST-N179, REF 410 640, For In Vitro...	bioMerieux, Inc.	LON	2010-09-16
Z-0277-2011		VITEK 2 Gram Negative Susceptibility Card, AST-N178, REF 410 393, For In Vitro...	bioMerieux, Inc.	LON	2010-09-16
Z-0276-2011		VITEK 2 Gram Negative Susceptibility Card, AST-N177, REF 410 392, For In Vitro...	bioMerieux, Inc.	LON	2010-09-16
Z-0275-2011		VITEK 2 Gram Negative Susceptibility Card, AST-N176, REF 410 402, For In Vitro...	bioMerieux, Inc.	LON	2010-09-16
Z-0274-2011		VITEK 2 Gram Negative Susceptibility Card, AST-N175, REF 410 403, For In Vitro...	bioMerieux, Inc.	LON	2010-09-16
Z-0273-2011		VITEK 2 Gram Negative Susceptibility Card, AST-N174, REF 410 404, For In Vitro...	bioMerieux, Inc.	LON	2010-09-16
Z-0272-2011		VITEK 2 Gram Negative Susceptibility Card, AST-N172, REF 410 298, For In Vitro...	bioMerieux, Inc.	LON	2010-09-16
Z-0271-2011		VITEK 2 Gram Negative Susceptibility Card, AST-N171, REF 410 249, For In Vitro...	bioMerieux, Inc.	LON	2010-09-16
Z-0270-2011		VITEK 2 Gram Negative Susceptibility Card, AST-N170, REF 410 222, For In Vitro...	bioMerieux, Inc.	LON	2010-09-16
Z-0269-2011		VITEK 2 Gram Negative Susceptibility Card, AST-N168, REF 410 139, For In Vitro...	bioMerieux, Inc.	LON	2010-09-16
Z-0268-2011		VITEK 2 Gram Negative Susceptibility Card, AST-N167, REF 410 138, For In Vitro...	bioMerieux, Inc.	LON	2010-09-16