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 2026-10-19, the FDA export date. FDA medical device recall database

59,528 records, page 725 of 1191

FDA device recalls, page 725 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-0965-2014	Class III	D-10 Dual Program, which contains Update Kit D-10 A1c program diskette. United States...	Bio-Rad Laboratories Inc.	LCP	2013-11-22
Z-1182-2014	Class II	4043-2: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with...	Abbott Medical	JKA	2013-11-22
Z-1181-2014	Class II	4042-2: 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with...	Abbott Medical	JKA	2013-11-22
Z-1180-2014	Class II	4040-2: Umbilical 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per...	Abbott Medical	JKA	2013-11-22
Z-0734-2014	Class II	Oxoid Antimicrobial Susceptibility Testing Disc, MEM10, REF: CT0774B, 10 mcg meropenem...	Remel Inc	JTN	2013-11-21
Z-0616-2014	Class II	SYSTEM 1E Liquid Chemical Sterilant Processing System, Distributed by STERIS Corporation...	STERIS Corporation	MLR	2013-11-21
Z-0810-2014	Class II	Medrad Veris MR Monitor units The system is intended to monitor physiological...	Medrad, Inc.	MWI	2013-11-21
Z-0966-2014	Class II	Normative Data Template CD for use with the I-Portal devices. Used to measure, record...	Spryson America Inc	GWN	2013-11-21
Z-0568-2014	Class II	Ziehm Vision RFD C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic...	Ziehm Imaging GmbH	OWB	2013-11-21
Z-0567-2014	Class II	Ziehm Vision R C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic...	Ziehm Imaging GmbH	OWB	2013-11-21
Z-0566-2014	Class II	Ziehm Vision(2) FD C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic...	Ziehm Imaging GmbH	OWB	2013-11-21
Z-0565-2014	Class II	Ziehm Vision(2) C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic...	Ziehm Imaging GmbH	OWB	2013-11-21
Z-0564-2014	Class II	Ziehm Vision C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging	Ziehm Imaging GmbH	OWB	2013-11-21
Z-0563-2014	Class II	Ziehm Solo C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging	Ziehm Imaging GmbH	OWB	2013-11-21
Z-0562-2014	Class II	Ziehm Vista/Vista Plus C-Arm Interventional Fluoroscopic X-Ray System. Mobile...	Ziehm Imaging GmbH	OWB	2013-11-21
Z-0535-2014	Class II	3M ESPE Imprint II Regular Body , Catalog Number 9379, and Paradigm Regular Body VPS...	3M Company	ELW	2013-11-21
Z-0633-2014	Class II	The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These...	Welch Allyn Protocol, Inc.	MWI	2013-11-21
Z-0904-2014	Class II	ABX PENTRA N Control, Model No. A11A01653 The ABX PENTRA N Control is for use in quality...	Horiba Instruments Incorporated	JJY	2013-11-21
Z-2264-2014	Class II	All brochures printed before November 20, 2013 for the HyperBlue 1530 medical laser...	Hyperion Medical	PDZ	2013-11-20
Z-0981-2014	Class II	GE Healthcare, PET Discovery 610, Discovery 710, Discovery 600 and Discovery 690. The GE...	GE Healthcare	KPS	2013-11-20
Z-0964-2014	Class II	Stryker Orthopaedics Navigation Compatible Accolade Broach Handle 1 single unit to a...	Howmedica Osteonics Corp	LXH	2013-11-20
Z-0805-2014	Class II	ORCHESTRA/ORCHESTRA PLUS Programmer	Corcym Inc.	LNX	2013-11-20
Z-0560-2014	Class III	Edwards Lifesciences Ergonic Double Acting DeBakey Forceps with Narrow Straight Tip...	Edwards Lifesciences LLC	HTD	2013-11-20
Z-0555-2014	Class II	PedFuse Reset Screw Inserters; PedFuse Screw Inserter 08-9 REset Part# 11-80113 The...	SPINEFRONTIER, Inc. dba LESspine Innovations	MNI	2013-11-20
Z-0554-2014	Class II	PedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REspond Part# 11-80111 The...	SPINEFRONTIER, Inc. dba LESspine Innovations	MNI	2013-11-20
Z-0576-2014	Class II	Indus Invue Screws: IM71013-XX: Indus Screw04.0mm SelfDrilling. Used to secure the Invue...	SPINEFRONTIER, Inc. dba LESspine Innovations	KWQ	2013-11-20
Z-0575-2014	Class II	Indus Invue Screws: IM71016-XX: 04.5mm, SelfTapping. Used to secure the Invue Anterior...	SPINEFRONTIER, Inc. dba LESspine Innovations	KWQ	2013-11-20
Z-0574-2014	Class II	Indus Invue Screws: lM71059-XX: Indus Screw 04.2mm SelfDrilling. Used to secure the...	SPINEFRONTIER, Inc. dba LESspine Innovations	KWQ	2013-11-20
Z-0573-2014	Class II	Indus Invue Screws: IM71058-XX: 04.2mm, SelfTapping, Tapered. Used to secure the Invue...	SPINEFRONTIER, Inc. dba LESspine Innovations	KWQ	2013-11-20
Z-0724-2014	Class II	TWISTER PLUS 26mm Rotatable Retrieval Device (Box of 10 configuration) Intended to be...	Boston Scientific Corporation	FGX	2013-11-20
Z-0723-2014	Class II	TWISTER PLUS 26mm Rotatable Retrieval Device (Box of 5 configuration) Universal Product...	Boston Scientific Corporation	FGX	2013-11-20
Z-0722-2014	Class II	TWISTER PLUS 26mm Rotatable Retrieval Device (Box of 1 configuration) Universal Product...	Boston Scientific Corporation	FGX	2013-11-20
Z-0721-2014	Class II	TWISTER PLUS 22mm Rotatable Retrieval Device (Box of 10 configuration) Universal Product...	Boston Scientific Corporation	FGX	2013-11-20
Z-0720-2014	Class II	TWISTER PLUS 22mm Rotatable Retrieval Device (Box of 5 configuration) Universal Product...	Boston Scientific Corporation	FGX	2013-11-20
Z-0719-2014	Class II	TWISTER PLUS 22mm Rotatable Retrieval Device (Box of 1 configuration) Universal Product...	Boston Scientific Corporation	FGX	2013-11-20
Z-0543-2014	Class II	ClearSight(TM) Toric 1 day (ocufilcon D), 30 daily disposable contact lenses for...	CooperVision, Inc.	MVN	2013-11-20
Z-0542-2014	Class II	Pro clear(R) 1 day Sphere (o mafilcon A), 90 daily disposable contact lenses, STERILE, Rx...	CooperVision, Inc.	MVN	2013-11-20
Z-0553-2014	Class II	PedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REset Part #11-80110 The...	SPINEFRONTIER, Inc. dba LESspine Innovations	MNI	2013-11-20
Z-0481-2014	Class III	Opal Orthodontics by Ultradent. Avex CX2 Ceramic Orthodontic Brackets Avex CX2 ceramic...	Ultradent Products Inc.	NJM	2013-11-19
Z-0601-2014	Class II	Asante Conset Infusion Set with tubing & 9mm cannula packaged in 5-packs,singles,or...	Asante Solutions, Inc.	FPA	2013-11-19
Z-0600-2014	Class II	Asante Conset Infusion Set with 110cm tubing & 6mm cannula packaged in 5-packs...	Asante Solutions, Inc.	FPA	2013-11-19
Z-0599-2014	Class II	Asante Conset Infusion Set with 60cm tubing & 9mm cannula packaged in 5-packs,singles, or...	Asante Solutions, Inc.	FPA	2013-11-19
Z-0598-2014	Class II	Asante Conset Infusion Set with 60cm tubing & 6mm cannula packaged in 5-packs,singles,or...	Asante Solutions, Inc.	FPA	2013-11-19
Z-0597-2014	Class II	Asante Comfort Infusion Set with 110cm tubing & 17mm cannula packaged in 5-packs...	Asante Solutions, Inc.	FPA	2013-11-19
Z-0596-2014	Class II	Asante Comfort Infusion Set with 110cm tubing & 13mm cannula packaged in 5-packs,singles...	Asante Solutions, Inc.	FPA	2013-11-19
Z-0595-2014	Class II	Asante Comfort Infusion Set with 60cm tubing & 17mm cannula packaged in 5-packs...	Asante Solutions, Inc.	FPA	2013-11-19
Z-0594-2014	Class II	Asante Comfort Infusion Set with 60cm tubing & 13mm cannula packaged in 5-packs...	Asante Solutions, Inc.	FPA	2013-11-19
Z-0463-2014	Class II	NexGen Complete Knee Solution CR Articular Surface Provisional-Striped Green 9mm Height...	Zimmer GmbH	HWT	2013-11-19
Z-0462-2014	Class II	NexGen Complete Knee Solution CR Articular Surface Provisional-Yellow 9mm Height...	Zimmer GmbH	HWT	2013-11-19
Z-0461-2014	Class II	NexGen Complete Knee Solution CR Articular Surface Provisional-Purple 9mm...	Zimmer GmbH	HWT	2013-11-19