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 2026-10-12, the FDA export date. FDA medical device recall database

59,476 records, page 293 of 1190

FDA device recalls, page 293 of 1190
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-1477-2021	Class II	Stopcock rotator (Component): a. 1050 STOPCOCK ROTATOR, OFF HANDLE, Model Number...	Abbott Medical	DRS	2021-03-31
Z-1476-2021	Class II	Manifold rotator (Component): a. 250 2 GANG MANIFOLD ROTATOR, OFF HANDLE, Model Number...	Abbott Medical	DRS	2021-03-31
Z-1475-2021	Class II	ANGIOGRAPHIC KIT W/MX123-3MR MANIFOLD, Model Number MX1030. for use during angiography...	Abbott Medical	NEP	2021-03-31
Z-1474-2021	Class II	Gang Cath Lab Set, Model Number M20858R1.for the administration of IV fluids. Stopcocks...	Abbott Medical	FPB	2021-03-31
Z-1473-2021	Class II	LogiCal Left Heart Kit, Model Number M20553. for blood pressure monitoring.	Abbott Medical	DRS	2021-03-31
Z-1472-2021	Class II	Left Heart Kit, Model Number M20268. for blood pressure monitoring.	Abbott Medical	NEP	2021-03-31
Z-1471-2021	Class II	Mark 910 LogiCal, Model Number DPS567201. for blood pressure monitoring and blood...	Abbott Medical	DRS	2021-03-31
Z-1470-2021	Class II	LogiCal Monitoring Set, Model Number DPS564898. for blood pressure monitoring and blood...	Abbott Medical	DRS	2021-03-31
Z-1516-2021	Class II	ACE MDI Spacer with Small Mask - Product Usage: designed to assist with the delivery of...	Abbott Medical	CAF	2021-03-31
Z-1515-2021	Class II	Palm Cups - Product Usage: intended to be used to percuss the chest wall to mobilize the...	Abbott Medical	BYI	2021-03-31
Z-1496-2021	Class II	Artis systems - Product Usage: an angiography systems developed for single and biplane...	Siemens Medical Solutions USA, Inc.	OWB	2021-03-30
Z-1518-2021	Class II	Omnia Soft Tissue Punch is a dental instrument designed to remove with precision a...	Omnia SRL	EME	2021-03-30
Z-1681-2021	Class II	NPr FCZImp Crwn ASC CC NP CAD 1-25 s6 - Product Usage: Implant Crown intended to be...	Nobel Biocare Procera LLC	NHA	2021-03-29
Z-1680-2021	Class II	NPr FCZImp Crwn ASC CC RP CAD 1-25 s4 - Product Usage: Implant Crown intended to be...	Nobel Biocare Procera LLC	NHA	2021-03-29
Z-1679-2021	Class II	NPr FCZImp Crwn ASC CC NP CAD 1-25 s4 - Product Usage: Implant Crown intended to be...	Nobel Biocare Procera LLC	NHA	2021-03-29
Z-1678-2021	Class II	NPr FCZImp Crwn ASC CC RP CAD 1-25s3 - Product Usage: Implant Crown intended to be placed...	Nobel Biocare Procera LLC	NHA	2021-03-29
Z-1677-2021	Class II	NPr FCZImp Crwn ASC CC RP CAD 1-25 s2 - Product Usage: Implant Crown intended to be...	Nobel Biocare Procera LLC	NHA	2021-03-29
Z-1563-2021	Class II	Calibration Serum Level 3 (CAL 3) - multi-analyte mixture calibrator. Catalogue Number...	Randox Laboratories, Limited	JIX	2021-03-29
Z-1517-2021	Class II	Philips Xper Flex Cardio (FC2010, Procedure Room and FC2020, Bedside Monitor) devices...	Philips North America LLC	MWI	2021-03-29
Z-1562-2021	Class II	AFT Straight Tube (3/4 Filled) - Human Allograph Tissue for treatment of...	Musculoskeletal Transplant Foundation d/b/a/ MTF Biologics	MQV	2021-03-29
Z-1534-2021	Class II	VACUETTE Blood Collection tube 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white...	Greiner Bio-One North America, Inc.	GIM	2021-03-29
Z-1548-2021	Class II	Provox Life Night HME, Catalogue Number 8262 - Product Usage: single use heat and...	Atos Medical AB	BYD	2021-03-29
Z-1683-2021	Class II	PIC070 Arterial Blood Sampler PICO70 - Product Usage: Preheparinized...	Radiometer Medical ApS	JKA	2021-03-26
Z-1501-2021	Class II	InCore Lapidus Disposable Kit 28mm Right, Part Number: IC-LAP-28R - Product Usage...	Medartis AG	HWC	2021-03-26
Z-1495-2021	Class II	Artis zee ceiling-interventional Fluoroscopic X-Ray System Model Number: 10094137	Siemens Medical Solutions USA, Inc.	OWB	2021-03-26
Z-1433-2021	Class II	The AMS 700 Inflatable Penile Prosthesis is a closed fluid-filled system containing...	Boston Scientific Corporation	JCW	2021-03-26
Z-1500-2021	Class II	InCore Lapidus Disposable Kit 28mm Left, Part Number: IC-LAP-28L - Product Usage...	Medartis AG	HWC	2021-03-26
Z-1542-2021	Class II	Regard Dressing Change Tray	ROi CPS LLC	OXQ	2021-03-26
Z-1544-2021	Class I	Alaris Pump Module, Model 8100, serviced/repaired by Infusion Pump Repair with an...	Infusion Pump Repair	FRN	2021-03-26
Z-1489-2021	Class II	VITROS Black Reference Slides CATALOG #: J02316 - Product Usage: The Black Reference...	Ortho-Clinical Diagnostics, Inc.	N/A	2021-03-26
Z-1499-2021	Class II	KIT_INFINITY_BASE Custom Procedural Kit - Italy, containing Infinity ACL Tibial Elbow and...	ConMed Corporation	LXH	2021-03-26
Z-1498-2021	Class II	INFINITY_TRAY Custom Procedural Kit - Canada. containing Infinity ACL Tibial Elbow and...	ConMed Corporation	LXH	2021-03-26
Z-1770-2021	Class II	VERTEBREX SINGLE BALLOON KIT, REF VBRX-20-SBK-10. For use in Orthopedic / spinal...	Zavation	NDN	2021-03-25
Z-1769-2021	Class II	VERTEBREX SINGLE BALLOON KIT, REF VBRX-15-SBK-10. For use in Orthopedic / spinal...	Zavation	NDN	2021-03-25
Z-1768-2021	Class II	OsteoFlex Cement and Mixing System, REF VCF-OSFL. For use in Orthopedic / spinal...	Zavation	NDN	2021-03-25
Z-1767-2021	Class II	ZVPlasty, 11G, 15mm Traditional Bipedicular Kit, REF VCF-1115-2. For use in Orthopedic /...	Zavation	NDN	2021-03-25
Z-1766-2021	Class II	ZVplasty System, 20mm, Part# VCF-1020-2. For use in Orthopedic / spinal procedures.	Zavation	NDN	2021-03-25
Z-1765-2021	Class II	ZVplasty 10G, 20mm, Traditional Unipedicular Kit, REF VCF-1020-1. For use in Orthopedic...	Zavation	NDN	2021-03-25
Z-1764-2021	Class II	ZVplasty 10G, 15mm Single Balloon Kit, REF VCF-SBK. For use in Orthopedic / spinal...	Zavation	NDN	2021-03-25
Z-1763-2021	Class II	ZVplasty 10G, FLEX KYPHOPLASTY, REF VCF-1015-FLEX. For use in Orthopedic / spinal...	Zavation	NDN	2021-03-25
Z-1762-2021	Class II	ZVplasty System, 15mm, Part Numbers: a) VCF-1015-2 b) VCF-1015-2A. For use in...	Zavation	NDN	2021-03-25
Z-1761-2021	Class II	ZVplasty 10G, 15mm, Additional Level Kit, REF VCF-1015-1A. For use in Orthopedic /...	Zavation	NDN	2021-03-25
Z-1760-2021	Class II	ZVplasty System, 15mm, Part# VCF-1015-1. For use in Orthopedic / spinal procedures.	Zavation	NDN	2021-03-25
Z-1759-2021	Class II	ZVplasty System, 15mm, Part# VCF-1015-1. For use in Orthopedic / spinal procedures.	Zavation	NDN	2021-03-25
Z-1758-2021	Class II	ZVplasty, 10G, 10mm Double Balloon Kit, REF VCF-1010-DBK. For use in Orthopedic / spinal...	Zavation	NDN	2021-03-25
Z-1757-2021	Class II	ZVplasty System, 10mm, Pat# VCF-1010-2. For use in Orthopedic / spinal procedures.	Zavation	NDN	2021-03-25
Z-1756-2021	Class II	OsteoFlex BONE CEMENT, REF Numbers: a) INTV-OSFL b) INTV-OSFL-LV. For use in...	Zavation	NDN	2021-03-25
Z-1755-2021	Class II	InterV 11G Kyphoplasty Kit, REF Numbers: a) INTVMN-10-DSK b) INTVMN-15-DSK c)...	Zavation	NDN	2021-03-25
Z-1754-2021	Class II	InterV 10G Bone Access Tools/Kit, REF INTVM-FLNK. For use in Orthopedic / spinal...	Zavation	NDN	2021-03-25
Z-1753-2021	Class II	InterV CurvePlus Kit, REF Numbers: a) INTVMC-15-FLDSK b) INTVMC-20-FLDSK. For use in...	Zavation	NDN	2021-03-25