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 801 of 1190

FDA device recalls, page 801 of 1190
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-1435-2012		MEDPOR PLUS SST EZ 22mm Sphere Implant, Howmedica Osteonics Corp, 15 Dart Road, Newnan...	Porex Surgical, Inc.	HPZ	2012-03-20
Z-1419-2012		Epidural Administration Set with Non-Vented Bag Spike and 0.2 Micron Filter Packaged...	Zevex, Inc.	FRN	2012-03-20
Z-1418-2012		Non-DEHP Administration Set with Non-Vented Spike and 0.2 Micron Filter ASV Packaged...	Zevex, Inc.	FRN	2012-03-20
Z-1417-2012		Non-DEHP Microbore Administration Set with Non-Vented Spike ASV Needleless Injection Port...	Zevex, Inc.	FRN	2012-03-20
Z-1416-2012		Non-Vented Bag Spike, Microbore tubing w/free-flow protection, slide clamp ASV The...	Zevex, Inc.	FRN	2012-03-20
Z-1415-2012		Non-DEHP Microbore Administration Set with Non-Vented Spike ASV Packaged Assembly The...	Zevex, Inc.	FRN	2012-03-20
Z-1414-2012		Non-DEHP Epidural Administration Set with 0.2 Micron Filter Non-Vented Bag Spike ASV...	Zevex, Inc.	FRN	2012-03-20
Z-1413-2012		Non-DEHP Microbore Administration Set with Non-Vented Spike Packaged Assembly The Curlin...	Zevex, Inc.	FRN	2012-03-20
Z-1412-2012		Epidural OB Administration Set with Non-Vented Bag Spike and 0.2 Micron Filter Packaged...	Zevex, Inc.	FRN	2012-03-20
Z-1411-2012		Non-DEHP Epidural Yellow Striped Tubing Administration Set with Vented Vial Spike and 0.2...	Zevex, Inc.	FRN	2012-03-20
Z-1410-2012		Non-DEHP Microbore Administration Set with Female Male Luer Locks and Y-Site with Check...	Zevex, Inc.	FRN	2012-03-20
Z-1409-2012		Non-DEHP Microbore Administration Set with Non-Vented Spike and Y-Site with Checked Valve...	Zevex, Inc.	FRN	2012-03-20
Z-1408-2012		Curlin administration set with vented spike, 0.2 micron filter, and check valve The...	Zevex, Inc.	FRN	2012-03-20
Z-1407-2012		Non-DEHP Administration Set with Non-Vented Spike and 0.2 Micron Filter The Curlin...	Zevex, Inc.	FRN	2012-03-20
Z-1406-2012		Non-DEHP Administration Set with Non-Vented Spike and 1.2 Micron Filter and Check Valve...	Zevex, Inc.	FRN	2012-03-20
Z-1405-2012		Non-DEHP Administration Set with Non-Vented Spike and 1.2 Micron Filter Packaged...	Zevex, Inc.	FRN	2012-03-20
Z-1404-2012		Epidural Administration Set with 150 mL Bag and 0.2 Micron Filter Packaged Assembly The...	Zevex, Inc.	FRN	2012-03-20
Z-1403-2012		Epidural Administration Set with Non-Vented Bag Spike and 0.2 Micron Filter Packaged...	Zevex, Inc.	FRN	2012-03-20
Z-1402-2012		Non-DEHP Microbore Administration Set with Female Luer Adapter Packaged Assembly The...	Zevex, Inc.	FRN	2012-03-20
Z-1401-2012		Non-DEHP Microbore Administration Set with Non-Vented Spike Packaged Assembly The Curlin...	Zevex, Inc.	FRN	2012-03-20
Z-1429-2012		Norco Folding Shower Bench; Features a nonskid surface and handholds for added security...	North Coast Medical Inc	IKX	2012-03-20
Z-1438-2012		REF. CP113456, MAK OSS No Head Lock Pin, NO HEAD / WITH PLUG CO-CR-MO ALLOY/ARCOM...	Zimmer GmbH	KRO	2012-03-20
Z-2152-2012	Class III	Model 731 EMV+ Uni-Vent, Impact Instrumentation Inc., 27 Fairfield Place, West Caldwell...	ZOLL Medical Corporation	CBK	2012-03-19
Z-1676-2012		SOLUS Anterior Lumbar Interbody Fusion Spinal Spacer System, Solus Proximal/Distal...	Alphatec Spine, Inc.	MAX	2012-03-19
Z-1673-2012		HPBLUE: HARMONIC Blue Hand Piece; HP054: HARMONIC Hand Piece; Non-Sterile products are...	Ethicon Endo-Surgery Inc	LFL	2012-03-16
Z-1424-2012		DePuy Attune Impaction Handle Warsaw, IN 46582 Packaging: Product is packed within a...	Depuy Orthopaedics Inc.	LXH	2012-03-16
Z-1321-2012		Terumo Advanced Perfusion System 1 Base, 220/240V, Catalog 801764, 6 " Roller Pump...	Terumo Cardiovascular Systems Corporation	DTQ	2012-03-16
Z-1612-2012		Fresenius Medical Naturalyte Acid Concentrate for bicarbonate Dialysis 45x , 55 gallons...	Fresenius Medical Care Renal Therapies Group, LLC	KPO	2012-03-16
Z-1320-2012		Terumo Advanced Perfusion System 1 Base, 100/120V, Catalog 801763, 6 " Roller Pump...	Terumo Cardiovascular Systems Corporation	DTQ	2012-03-16
Z-2332-2012	Class II	Sunquest Laboratory Sunquest Laboratory is intended for use by professionals working in...	CliniSys, Inc	JQP	2012-03-15
Z-1472-2012		VITROS® 5,1 FS Refurbished System, Product Codes: 6801375 & 6801890 Product Usage: For...	Ortho-Clinical Diagnostics, Inc.	JJE	2012-03-15
Z-1394-2012		Boston Scientific, IMAGER II Angiographic Catheter, Sterilized with ethylene oxide gas...	Boston Scientific Corporation	DQO	2012-03-15
Z-1393-2012		Boston Scientific, IMAGER II Urology Torque Catheter, Sterilized with ethylene oxide gas...	Boston Scientific Corporation	KOD	2012-03-15
Z-1471-2012		VITROS® 5,1 FS System, Product Codes: 6801375 & 6801890 Product Usage: For use in the...	Ortho-Clinical Diagnostics, Inc.	JJE	2012-03-15
Z-1470-2012		VITROS® 5600 Chemistry System, Product Code: 6802413 Product Usage: For use in the in...	Ortho-Clinical Diagnostics, Inc.	JJE	2012-03-15
Z-1469-2012		VITROS® 4600 Chemistry System, Product Code: 6802445 Product Usage: For use in the in...	Ortho-Clinical Diagnostics, Inc.	JJE	2012-03-15
Z-1468-2012		VITROS® 3600 Immunodiagnostic System Product Usage: For use in the in vitro...	Ortho-Clinical Diagnostics, Inc.	JJE	2012-03-15
Z-1439-2012		Optilock, Locking Screw 3.5 mm x 28 mm, non sterile, REF 37728, Biomet Trauma Parsippany...	Zimmer GmbH	HRS	2012-03-15
Z-0653-2013	Class II	UltraFill DBM labeled in part: TISSUENET Sterilized by T10^6 Description: UltraFill...	Surgical Tissue Network, Inc.	MQV	2012-03-14
Z-0652-2013	Class II	UltraFill DBM labeled in part: TISSUENET Sterilized by T10^6 Description: UltraFill DBM...	Surgical Tissue Network, Inc.	MQV	2012-03-14
Z-0651-2013	Class II	Ultrafill DBM labeled in part: TISSUENET Sterilized by T10^6 Description: UltraFill DBM...	Surgical Tissue Network, Inc.	MQV	2012-03-14
Z-1489-2012		EG-3870UTK, Pentax Ultrasound Video Gastroscope. The EG-3870UTK, Ultrasound Video...	PENTAX of America, Inc.	ITX	2012-03-14
Z-1281-2012		VeinViewer (R) by Luminetx, Model Number VV1.1 GS, Part No. P00800-L, Luminetx...	Christie Medical Holdings, Inc.	KZA	2012-03-14
Z-1280-2012		VeinViewer (R) by Luminetx, Model Number VV1.0, Part No: P00399-L, Luminetx Corporation...	Christie Medical Holdings, Inc.	KZA	2012-03-14
Z-2586-2017	Class II	Pointe Scientific Hitachi Total Bilirubin Rl Reagent Product Usage: Two part Chemistry...	Horiba Instruments Incorporated	CIG	2012-03-13
Z-0998-2013	Class II	STERRAD 200 System Carriage, P/N 10208. Used as a tool to expedite loading and unloading...	Advanced Sterilization Products	MLR	2012-03-13
Z-1444-2012		VERTEX MAX (R) Cannulated, VERTEX MAX (R), and VERTEX (R) Reconstruction System...	Medtronic Sofamor Danek USA Inc	LXH	2012-03-13
Z-1443-2012		PREMIER(R) Anterior Cervical Plate System Adjustable Drill Stop, REF 6905712, QTY: 1 EA...	Medtronic Sofamor Danek USA Inc	LXH	2012-03-13
Z-1442-2012		ATLANTIS(TM) Anterior Cervical Plate System Adjustable Drill Stop, REF 876-460, QTY: 1...	Medtronic Sofamor Danek USA Inc	LXH	2012-03-13
Z-1395-2012		12Fr SLS II Laser Sheath. The laser sheath is intended for use as an adjunct to...	Spectranetics Corp.	LPC	2012-03-13