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 757 of 1190

FDA device recalls, page 757 of 1190
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-2116-2013	Class II	SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare...	GE Healthcare	MHX	2013-04-03
Z-2115-2013	Class II	GE Healthcare, Dash 3000, Dash 4000 and Dash 5000. Product Usage: The intended use of...	GE Healthcare	MHX	2013-04-03
Z-1598-2013	Class II	TOSHIBA Kalare Diagnostic X-Ray System K110785	Canon Medical Systems USA, Inc.	JAA	2013-04-03
Z-1337-2013	Class III	VITROS Immunodiagnostic Products CK-MB Calibrators, REF 128 6293, IVD, Ortho-Clinical...	Ortho-Clinical Diagnostics, Inc.	JIX	2013-04-03
Z-1115-2013	Class II	Product is distributed by Zimmer (Warsaw, Indiana)/Synvasive Technology, Inc. (El Dorado...	Synvasive Technology, Inc.	GFA	2013-04-02
Z-1858-2013	Class I	List No. 14219-28; Y-TYPE BLOOD SET; 200 Micron Filter, Cylinder Pump, CLAVE Y-Site...	Abbott Medical	BRZ	2013-04-01
Z-1857-2013	Class I	List No. 14217-28; Y-TYPE BLOOD SET; 200 Micron Filter, Prepierced Y-Site, Non-Vented, 80...	Abbott Medical	BRZ	2013-04-01
Z-1856-2013	Class I	List No. 14212-28; PLUM Y-TYPE BLOOD SET; 200 Micron Filter, CLAVE Port, Non-Vented, 110...	Abbott Medical	BRZ	2013-04-01
Z-1855-2013	Class I	List No. 14211-28; PLUM BLOOD SET; Prepierced Port, 200 Micron Filter, 110 Inch...	Abbott Medical	BRZ	2013-04-01
Z-1854-2013	Class I	List No. 14210-28; PLUM BLOOD SET; 100 mL Burette with Prepierced Injection Site, 170...	Abbott Medical	BRZ	2013-04-01
Z-1853-2013	Class I	List No. 14207-28; BLOOD SET; 200 Micron Filter, 105 Inch, Non-DEHP; For Blood Product...	Abbott Medical	BRZ	2013-04-01
Z-1852-2013	Class I	List No. 14206-28; Y-TYPE BLOOD SET; 200 Micron Filter, Cylinder Pump, Convertible Pin...	Abbott Medical	BRZ	2013-04-01
Z-1851-2013	Class I	List No. 14203-28; BLOOD SET; 200 Micron Filter, 80 Inch, Non-DEHP; For Blood Product...	Abbott Medical	BRZ	2013-04-01
Z-1850-2013	Class I	List No. 14200-28; SECONDARY BLOOD SET; 200 Micron Filter, 36 Inch, Non-DEHP; For Blood...	Abbott Medical	BRZ	2013-04-01
Z-2082-2013	Class II	2008 MeDS Pump, Venofer(R) Pump Product Usage: The 2008 MeDs pump is an optional...	Fresenius Kabi Warrendale	KDI	2013-04-01
Z-1346-2013	Class II	cobas 4800 system z480 instrument. Integrates fully automated total nucleic acid...	Roche Molecular Systems Inc	OOI	2013-04-01
Z-1556-2013	Class II	VITROS Chemistry Products-HCY Reagent packaged in a kit carton. Catalog# 6802002. Used...	Ortho-Clinical Diagnostics, Inc.	LPS	2013-04-01
Z-1213-2013	Class II	3DKnee e+ Tibial Insert. The insert is used along with the other components that comprise...	Encore Medical, LP	OIY	2013-04-01
Z-0949-2014	Class II	The UF-1000i is a fully automated urine particle analyzer intended for vitro diagnostic...	Sysmex America, Inc.	LKM	2013-03-31
Z-1516-2013	Class II	American Optisurgical's TX1 Tissue Removal System Console. The console is a software unit...	Tenex Health	LFL	2013-03-30
Z-1887-2013	Class I	Cordis OPTEASE Retrieval Inferior Vena Cava (IVC) Filter*REF Cat. No.*466F220A and...	Cordis US Corp.	DTK	2013-03-29
Z-1491-2014	Class III	The CEP 8 SpectrumGreen (SG) ASR Probe Kit, 20ul (list 06J37-018) is an Analyte Specific...	Abbott Molecular, Inc.	MVU	2013-03-28
Z-1322-2014	Class II	Integrity 1.1. Integrity is the interface and control software for the Elekta range of...	Elekta Limited	IYE	2013-03-28
Z-1819-2013	Class II	Custom Spine ISSYS LP Inverted Screw System. 8.5MM X 45 MM ISSYS LP Screw Rx...	Custom Spine, Inc.	NKB	2013-03-28
Z-1302-2013	Class II	Absorbable Collagen Sponge Provided As Intermediate to Another Company	Integra LifeSciences Corporation	LMF	2013-03-28
Z-1301-2013	Class II	BioMend Absorbable Collagen Membrane BioMend Absorbable Collagen Membrane is an...	Integra LifeSciences Corporation	LYC	2013-03-28
Z-1210-2013	Class II	Stryker Howmedica Osteonics Corp. AxSOS System Instrument. The AxSOS Locking Plate...	Howmedica Osteonics Corp	HTW	2013-03-28
Z-1212-2013	Class II	Optima MR430s MRI Scanner; 5000-0002 is indicated to use as a magnetic resonance imaging...	GE Healthcare	LNH	2013-03-28
Z-1211-2013	Class II	MSK EXTREME MR SCANNER, MODEL AA5000 The intended for use as a diagnostic imaging device...	GE Healthcare	LNH	2013-03-28
Z-1081-2013	Class II	Siemens brand ACUSON SC2000 Ultrasound System, Model 10433816, hardware that contains...	Siemens Medical Solutions USA, Inc.	IYN	2013-03-28
Z-1244-2013	Class II	Wallace Sure-Pro Single Stage Embryo Replacement Catheter Product Code: PP623 Sure-Pro...	Abbott Medical	MQF	2013-03-28
Z-1300-2013	Class II	Layershield Adhesion Barrier Matrix Layershield Adhesion Barrier Matrix is an absorbable...	Integra LifeSciences Corporation	GXQ	2013-03-28
Z-1299-2013	Class II	BioMend Extend" Absorbable Collagen Membrane BioMend Extend" Absorbable Collagen...	Integra LifeSciences Corporation	LYC	2013-03-28
Z-1298-2013	Class II	OraMem Absorbable Collagen Membrane OraMem Absorbable Collagen Membrane is an...	Integra LifeSciences Corporation	LYC	2013-03-28
Z-1297-2013	Class II	Ora Plug Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen...	Integra LifeSciences Corporation	LPG	2013-03-28
Z-1296-2013	Class II	OraTape Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen...	Integra LifeSciences Corporation	LPG	2013-03-28
Z-1295-2013	Class II	HeliPlug Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen...	Integra LifeSciences Corporation	LPG	2013-03-28
Z-1294-2013	Class II	HeliTape Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen...	Integra LifeSciences Corporation	LPG	2013-03-28
Z-1150-2013	Class II	EVOTECH Endoscope Cleaner and Reprocessor System, P/N 50004. Designed to automatically...	Advanced Sterilization Products	FEB	2013-03-28
Z-1293-2013	Class II	CollaPlug Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen...	Integra LifeSciences Corporation	LPG	2013-03-28
Z-1292-2013	Class II	CollaCote Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen...	Integra LifeSciences Corporation	LPG	2013-03-28
Z-1291-2013	Class II	Colla Tape Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen...	Integra LifeSciences Corporation	LPG	2013-03-28
Z-1290-2013	Class II	Helitene Absorbable Collagen Hemostatic Sponge Helitene is indicated in surgical...	Integra LifeSciences Corporation	LMF	2013-03-28
Z-1289-2013	Class II	Helistat Absorbable Hemostatic,Collagen Based Helistat is indicated in surgical...	Integra LifeSciences Corporation	LMF	2013-03-28
Z-1288-2013	Class II	INSTAT - Agent, Absorbable Hemostatic, Collagen Based INSTAT MCH is recommended for use...	Integra LifeSciences Corporation	LMF	2013-03-28
Z-1287-2013	Class II	NeuraGen Nerve Guide NeuraGen Nerve Guide is indicated for repair of peripheral nerve...	Integra LifeSciences Corporation	JXI	2013-03-28
Z-1286-2013	Class II	NeuraWrap Nerve Protector NeuraWrap Nerve Protector is indicated for the management of...	Integra LifeSciences Corporation	JXI	2013-03-28
Z-1285-2013	Class II	DuraGen XS Dural Regeneration Matrix DuraGen XS Dural Regenerative Matrix is an...	Integra LifeSciences Corporation	GXQ	2013-03-28
Z-1284-2013	Class II	DuraGen Plus Dural Regeneration Matrix DuraGen Plus Adhesion Barrier Matrix is an...	Integra LifeSciences Corporation	GXQ	2013-03-28
Z-1283-2013	Class II	Suturable DuraGen Dural Regenerative Matrix Suturable DuraGen Dural Regenerative Matrix...	Integra LifeSciences Corporation	GXQ	2013-03-28