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 824 of 1190

FDA device recalls, page 824 of 1190
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-0104-2012		Synthes Spine Zero-P Instruments and Implants. Zero-profile anterior cervical interbody...	Synthes GmbH	ODP	2011-09-23
Z-0161-2012		Synthes Spine T-PAL Spacer System. Transforaminal posterior atraumatic lumbar spacer...	Synthes GmbH	MAX	2011-09-23
Z-0142-2012		CDI Blood Parameter Monitoring System 500 including all Catalog Numbers to include...	Terumo Cardiovascular Systems Corporation	DRY	2011-09-23
Z-0689-2012		MAQUET QUADROX iD PEDIATRIC -OXYGENATOR: BEQ-HMOD 3000; Made In Germany The diffusion...	Maquet Cardiovascular Us Sales, LLC	DTZ	2011-09-22
Z-0335-2012		Brilliance 64 Computed Tomography X-Ray System, 510(k) #K033326, Model Number: 728231...	Philips North America LLC	JAK	2011-09-22
Z-0334-2012		Brilliance Big Bore Computed Tomography X-Ray System, 510(k) #K033357, Model Number...	Philips North America LLC	JAK	2011-09-22
Z-0115-2012		GE SENOGRAPHE DS FULL FIELD DIGITAL ESSENTIAL MAMMOGRAPHY SYSTEM. The Senographe DS...	GE Healthcare	MUE	2011-09-22
Z-0114-2012		GE SENOGRAPHE ESSENTIAL FULL FIELD MAMMOGRAPHY SYSTEM (SENO ESSENTIAL). The Senographe...	GE Healthcare	MUE	2011-09-22
Z-0522-2012		syngo.plaza Image processing system	Siemens Medical Solutions USA, Inc.	LLZ	2011-09-21
Z-0443-2012		"*BUECHEL-PAPPAS MODULAR TIBIAL BEARING MATERIAL UHMWPe**STERILE...	Endotec, Inc.	NRA	2011-09-21
Z-0442-2012		"*BUECHEL-PAPPAS MODULAR TIBIAL BEARING MATERIAL UHMWPe**STERILE...	Endotec, Inc.	NRA	2011-09-21
Z-0441-2012		"*BUECHEL-PAPPAS MODULAR TIBIAL BEARING MATERIAL UHMWPe**STERILE...	Endotec, Inc.	NRA	2011-09-21
Z-0440-2012		"*BUECHEL-PAPPAS MODULAR TIBIAL BEARING MATERIAL UHMWPe**STERILE...	Endotec, Inc.	NRA	2011-09-21
Z-0439-2012		"*BUECHEL-PAPPAS CRUCIATE SACRIFICING BEARING MATERIAL UHMWPe**STERILE...	Endotec, Inc.	NRA	2011-09-21
Z-0438-2012		"*BUECHEL-PAPPAS CRUCIATE SACRIFICING BEARING MATERIAL UHMWPe**STERILE...	Endotec, Inc.	NRA	2011-09-21
Z-0437-2012		"*BUECHEL-PAPPAS CRUCIATE SACRIFICING BEARING MATERIAL UHMWPe**STERILE...	Endotec, Inc.	NRA	2011-09-21
Z-0436-2012		"*BUECHEL-PAPPAS CRUCIATE SACRIFICING BEARING MATERIAL UHMWPe**STERILE...	Endotec, Inc.	NRA	2011-09-21
Z-0191-2012		Spectra Optia Apheresis System, REF: 61000, Caridian BCT, Lakewood, CO 80215. A blood...	Terumo BCT, Ltd	LKN	2011-09-21
Z-0164-2012		BioPro Femoral Head 28 mm +18, Item 19010. Orthopedic femoral head for implantation	Biopro, Inc.	JDI	2011-09-21
Z-0163-2012		BioPro Femoral Head 28 mm -6 mm, Item 19003. Orthopedic femoral head for implantation.	Biopro, Inc.	JDI	2011-09-21
Z-0435-2012		"*BUECHEL-PAPPAS Conforming BearingUHMWPESIZECATSTERILEENDOTEC*Endotec...	Endotec, Inc.	NRA	2011-09-21
Z-0434-2012		"*BUECHEL-PAPPAS Conforming BearingUHMWPESIZECATSTERILEENDOTEC*Endotec...	Endotec, Inc.	NRA	2011-09-21
Z-0433-2012		"*BUECHEL-PAPPAS Conforming BearingUHMWPESIZECATSTERILEENDOTEC*Endotec...	Endotec, Inc.	NRA	2011-09-21
Z-0432-2012		"*BUECHEL-PAPPAS Conforming BearingUHMWPESIZECATSTERILEENDOTEC*Endotec...	Endotec, Inc.	NRA	2011-09-21
Z-0431-2012		"*BUECHEL-PAPPAS Conforming BearingUHMWPESIZECATSTERILEENDOTEC*Endotec...	Endotec, Inc.	NRA	2011-09-21
Z-1221-2012		Crystal Metal Disposable Blades size Mac 4 (part number 50674, 50674/F, 50674/BMI) and...	Penlon, Ltd.	CCW	2011-09-21
Z-0444-2013	Class II	Pentron Clinical Metrex Research; Pinnacle Cure Sleeve, a protective barrier The intended...	Metrex Research	MMP	2011-09-20
Z-0514-2012		syngo Imaging XS, all versions Radiological image processing system	Siemens Medical Solutions USA, Inc.	LLZ	2011-09-20
Z-0276-2012		Sensar Foldable IOL with OptiEdge. Model number AR40e 21.5 Diopter. The Sensar Foldable...	Advanced Medical Optics, Inc.	HQL	2011-09-20
Z-0275-2012		Sensar Foldable IOL with OptiEdge. Model number AR40e, 6.0 Diopter. The Sensar Foldable...	Advanced Medical Optics, Inc.	HQL	2011-09-20
Z-0266-2012		Rapid Strand Rx; the RAPID Strand Rx kit consists of custom loaded absorbable seeding...	GE Heathcare, Inc.	KXK	2011-09-20
Z-0067-2012		ANCHORLOK(R) LEADING EDGE(R) SOFT TISSUE ANCHOR SYSTEM, 7.5mm, 2 SUTURE, REF 5100-0020, 1...	Wright Medical Technology Inc	MBI	2011-09-20
Z-0066-2012		ANCHORLOK(R) LEADING EDGE(R) SOFT TISSUE ANCHOR SYSTEM, 5.0mm, 2 SUTURE, REF 5100-0018, 1...	Wright Medical Technology Inc	MBI	2011-09-20
Z-0065-2012		ANCHORLOK(R) LEADING EDGE(R) SOFT TISSUE ANCHOR SYSTEM, 5.0mm, 0 SUTURE, REF 5100-0016, 1...	Wright Medical Technology Inc	MBI	2011-09-20
Z-0064-2012		ANCHORLOK(R) LEADING EDGE(R) SOFT TISSUE ANCHOR SYSTEM, 3.5mm, 2 SUTURE, REF 5100-0014, 1...	Wright Medical Technology Inc	MBI	2011-09-20
Z-0063-2012		ANCHORLOK(R) LEADING EDGE(R) SOFT TISSUE ANCHOR SYSTEM, 3.5mm, 0 SUTURE, REF 5100-0012, 1...	Wright Medical Technology Inc	MBI	2011-09-20
Z-0062-2012		ANCHORLOK(R) LEADING EDGE(R) SOFT TISSUE ANCHOR SYSTEM, 2.5mm, 2 SUTURE, REF 5100-0010, 1...	Wright Medical Technology Inc	MBI	2011-09-20
Z-0061-2012		ANCHORLOK(R) LEADING EDGE(R) SOFT TISSUE ANCHOR SYSTEM, 2.5mm, 0 SUTURE, REF 5100-008, 1...	Wright Medical Technology Inc	MBI	2011-09-20
Z-0060-2012		ANCHORLOK(R) LEADING EDGE(R) SOFT TISSUE ANCHOR SYSTEM, 2.5mm, 2.0 SUTURE, REF 5100-006...	Wright Medical Technology Inc	MBI	2011-09-20
Z-0059-2012		ANCHORLOK(R) LEADING EDGE(R) SOFT TISSUE ANCHOR SYSTEM, 1.9mm, 0 SUTURE, REF 5100-004,1...	Wright Medical Technology Inc	MBI	2011-09-20
Z-0058-2012		ANCHORLOK(R) LEADING EDGE(R) SOFT TISSUE ANCHOR SYSTEM, 1.9mm, 2.0 SUTURE, REF 5100-002...	Wright Medical Technology Inc	MBI	2011-09-20
Z-0080-2012		"*Vipat REF H0020-100Lot 1005332015-04*STERILE EO Elastomeric...	Victus, Inc.	MEB	2011-09-20
Z-1429-2013	Class II	da Vinci Si Surgeon Console. Intended to assist in the accurate Control of Intuitive...	Intuitive Surgical, Inc.	NAY	2011-09-19
Z-1428-2013	Class II	Flush Port (used in almost all da Vinci instruments) Assists in cleaning the instrument.	Intuitive Surgical, Inc.	NAY	2011-09-19
Z-1427-2013	Class II	Cannula 8MM Regular. Provides the means of introduction and placement of an instrument...	Intuitive Surgical, Inc.	NAY	2011-09-19
Z-2077-2012	Class II	.*ANSPACHSterile. REF SHD-4820DS**QTY: 1, 4.8 mm x 2mm Twist Drill with Depth Stop...	The Anspach Effort, Inc.	HTW	2011-09-19
Z-0515-2012		syngo Imaging XS, versions VA70A and VA70B Client/Server Installations Radiological...	Siemens Medical Solutions USA, Inc.	LLZ	2011-09-19
Z-0389-2012		Magnus Hybrid operating table columns 1180.01A1 and 1180.01B1	Maquet Cardiovascular Us Sales, LLC	LFQO	2011-09-19
Z-0354-2012		Maquet PC Board PC1772 Spare Part Device Part number 64 67 620 Intended for treatment of...	Maquet Cardiovascular Us Sales, LLC	CBK	2011-09-19
Z-0353-2012		Maquet Servo-S ventilator system Device Part number 66 40 440 Intended for treatment of...	Maquet Cardiovascular Us Sales, LLC	CBK	2011-09-19