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 764 of 1190

FDA device recalls, page 764 of 1190
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-1106-2013	Class II	VITROS 5,1 FS Chemistry System, Product Code 6801375 and VITROS 5,1 FS Chemistry System...	Ortho-Clinical Diagnostics, Inc.	JJE	2013-02-07
Z-0970-2013	Class II	CR MD1.0 General Set, x-ray imager image plate. CR 10-X Image Plate 35CM X 43CM. An...	AGFA Healthcare Corp.	MQB	2013-02-07
Z-0954-2013	Class II	Biomet Spine Polaris 5.5 Button Lock Screw Inserter. Catalog Number 14-500178. The...	Ebi, LLC	HXX	2013-02-07
Z-0891-2013	Class II	Technocut Plus, Sterile Single Use Safety Scalpel, Distributed by: Myco Medical.	Myco Medical Supplies Inc	GDX	2013-02-07
Z-0944-2013	Class II	INTERNAL HEX RECON SCREW, TI-6AL-4V, REF 7162375, TRIGEN (R) INTERNAL HEX CAPTURED RECON...	Smith & Nephew, Inc.	JDS	2013-02-07
Z-0943-2013	Class II	INTERNAL HEX RECON SCREW, TI-6AL-4V, REF 7162380, TRIGEN (R) INTERNAL HEX CAPTURED RECON...	Smith & Nephew, Inc.	JDS	2013-02-07
Z-2730-2016	Class II	Plum A+3 Infusion Pump with Hospira MedNet Software. List Number 20678. The Plum A+...	Abbott Medical	FRN	2013-02-06
Z-2729-2016	Class II	Plum A+3 Infusion Pump. List Number 12618. The Plum A+ Infusion Systems are a...	Abbott Medical	FRN	2013-02-06
Z-2728-2016	Class II	Plum A+3 Infusion Pump System. List Number 12348. The Plum A+ Infusion Systems are a...	Abbott Medical	FRN	2013-02-06
Z-1131-2013	Class II	Heritage Labs Path Study Extra Supplies Kit, Product # A 2376, kit contains 3 zippered...	Heritage Labs International LLC	KST	2013-02-06
Z-1014-2013	Class I	Smiths Medical, BCI Remote Alarm Cable (Normally Open & Normally Closed), Reorder...	Abbott Medical	CCK	2013-02-06
Z-1013-2013	Class II	bioMerieux VITEK 2 AST-ST01 Streptococcus Susceptibility Card, REF 410 028. For use with...	bioMerieux, Inc.	LTW	2013-02-06
Z-2727-2016	Class II	Plum A+ Infusion Pump with Hospira MedNet Software. List Number 20792. The Plum A+...	Abbott Medical	FRN	2013-02-06
Z-2726-2016	Class II	Plum A+ Infusion Pump with Hospira MedNet Software. List Number 20679. The Plum A+...	Abbott Medical	FRN	2013-02-06
Z-2725-2016	Class II	Plum A+3 Infusion Pump. List Number 12391. The Plum A+ Infusion Systems are a...	Abbott Medical	FRN	2013-02-06
Z-2724-2016	Class II	Plum A+ Infusion Pump. List Number 11973. The Plum A+ Infusion Systems are a...	Abbott Medical	FRN	2013-02-06
Z-2723-2016	Class II	Plum A+ Infusion Pump. List Number 11971. The Plum A+ Infusion Systems are a...	Abbott Medical	FRN	2013-02-06
Z-2722-2016	Class II	Plum A+ Hyperbaric Infusion Pump. List Number 11005. The Plum A+ Infusion Systems are a...	Abbott Medical	FRN	2013-02-06
Z-0099-2018	Class II	ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled...	Zimmer GmbH	HAW	2013-02-05
Z-2103-2013	Class II	SpineNet Anterior Cervical Cage, Lordotic, Peek (originally submitted as Daytona Anterior...	SpineNet LLC	ODP	2013-02-05
Z-0971-2013	Class II	Specialist 2 IM Rod, Non-Sterile and associated Surgical Techniques: Sigma HP...	Depuy Orthopaedics Inc.	LXH	2013-02-05
Z-1002-2013	Class II	Vitrea Enterprise Suite, Vitrea, VitreaAdvanced, VitreaCore (VitalConnect) and Vitrea fX...	Canon Medical Informatics, Inc.	LLZ	2013-02-05
Z-0925-2013	Class II	REF S313152 Straight Acetabular Inserter Handle Ringloc non-sterile Orthopedic manual...	Zimmer GmbH	LXH	2013-02-05
Z-1784-2014	Class II	Cordis EMPIRA RX PTCA Dilatation Catheter Catalog # 85R30300S For cardiovascular use.	Cordis US Corp.	LOX	2013-02-05
Z-0354-2017	Class II	Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V...	Abbott Medical	FRN	2013-02-05
Z-0353-2017	Class II	Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V...	Abbott Medical	FRN	2013-02-05
Z-1007-2015	Class II	The Arrow Edge Hemodialysis Catheterization Set Long-Term Access and NextStep Antegrade...	Arrow International LLC (subsidiary of Teleflex Incorporated)	MSD	2013-02-04
Z-2107-2013	Class II	SpineNet Bone Marrow Aspiration Needle Kit (which is the Ranfac Bone Marrow Aspiration...	SpineNet LLC	GAA	2013-02-04
Z-1847-2013	Class II	The Hospira Symbiq Infusion System is intended for the delivery of fluids, solutions...	Abbott Medical	FRN	2013-02-04
Z-1022-2013	Class II	Gen-Probe LIFECODES PF4 Enhanced assay, Catalog No. X-HAT45 GTI PF4 Enhanced is designed...	Immucor GTI Diagnostics, Inc.	LCO	2013-02-04
Z-1136-2013	Class II	EndoGastric Solutions EsophyX2 Plus Device with Serosa Fastener and Accessories Part...	Endogastric Solutions, Inc.	ODE	2013-02-04
Z-0812-2013	Class III	Ultradent Products, Chromaclone PVS, Fast Set heavy body, Bubble Gum Flavor, 50 ml...	Ultradent Products Inc.	ELW	2013-02-04
Z-0811-2013	Class III	Ultradent Products, Chromaclone PVS, Regular Set heavy body, Bubble Gum Flavor, 50 ml...	Ultradent Products Inc.	ELW	2013-02-04
Z-0306-2017	Class II	Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V...	Abbott Medical	FRN	2013-02-04
Z-0305-2017	Class II	Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V...	Abbott Medical	FRN	2013-02-04
Z-2056-2016	Class II	Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V...	Abbott Medical	FRN	2013-02-04
Z-2055-2016	Class II	Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V...	Abbott Medical	FRN	2013-02-04
Z-2683-2017	Class II	The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise...	Abbott Medical	FRN	2013-02-01
Z-2682-2017	Class II	The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise...	Abbott Medical	FRN	2013-02-01
Z-2681-2017	Class II	The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise...	Abbott Medical	FRN	2013-02-01
Z-2680-2017	Class II	The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise...	Abbott Medical	FRN	2013-02-01
Z-0290-2014	Class II	The Plum A+ Infusion System is a cassette based multifunction infusion system that allows...	Abbott Medical	FRN	2013-02-01
Z-0289-2014	Class II	The Plum A+3 Infusion System is a cassette based multifunction infusion system that...	Abbott Medical	FRN	2013-02-01
Z-0288-2014	Class II	The Plum A+3 Infusion System is a cassette based multifunction infusion system that...	Abbott Medical	FRN	2013-02-01
Z-0287-2014	Class II	The Plum A+ Infusion System is a cassette based multifunction infusion system that allows...	Abbott Medical	FRN	2013-02-01
Z-0286-2014	Class II	The Plum A+3 Infusion System is a cassette based multifunction infusion system that...	Abbott Medical	FRN	2013-02-01
Z-0285-2014	Class II	The Plum A+ Infusion System is a cassette based multifunction infusion system that allows...	Abbott Medical	FRN	2013-02-01
Z-0284-2014	Class II	The Plum A+ Infusion System is a cassette based multifunction infusion system that allows...	Abbott Medical	FRN	2013-02-01
Z-1685-2013	Class II	Integra Hallu-Fix cannulated screw driver (model number P/N 129733ND) and cannulated...	Integra LifeSciences Corporation	LRZ	2013-02-01
Z-2679-2017	Class II	The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise...	Abbott Medical	FRN	2013-02-01