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 747 of 1191

FDA device recalls, page 747 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-0310-2014	Class II	VITROS Chemistry Products DGXN Slides packaged as 90 slides/pack catalog number...	Ortho-Clinical Diagnostics, Inc.	LFM	2013-06-12
Z-0309-2014	Class II	VITROS Chemistry Products CRP Slides packaged as 90 slides/pack catalog number...	Ortho-Clinical Diagnostics, Inc.	DCK	2013-06-12
Z-0308-2014	Class II	VITROS Chemistry Products CREA Slides packaged as 300 slides/pack catalog number...	Ortho-Clinical Diagnostics, Inc.	JFY	2013-06-12
Z-0307-2014	Class II	VITROS Chemistry Products CRBM Slides packaged as 90 slides/pack catalog number 8892382	Ortho-Clinical Diagnostics, Inc.	KLT	2013-06-12
Z-0306-2014	Class II	VITROS Chemistry Products CK-MB Slides packaged as 300 slides/pack catalog number 8058232...	Ortho-Clinical Diagnostics, Inc.	JHS	2013-06-12
Z-0305-2014	Class II	VITROS Chemistry Products CK Slides packaged as 300 slides/pack catalog number 8479396...	Ortho-Clinical Diagnostics, Inc.	JHS	2013-06-12
Z-0304-2014	Class II	VITROS Chemistry Products CHOL Slides packaged as 300 slides/pack catalog number 1669829...	Ortho-Clinical Diagnostics, Inc.	CHH	2013-06-12
Z-0303-2014	Class II	VITROS Chemistry Products CHE Slides packaged as 300 slides/pack catalog number 1914605...	Ortho-Clinical Diagnostics, Inc.	DIH	2013-06-12
Z-0302-2014	Class II	VITROS Chemistry Products Ca Slides packaged as 300 slides/pack catalog number...	Ortho-Clinical Diagnostics, Inc.	CJY	2013-06-12
Z-0301-2014	Class II	VITROS Chemistry Products BUN/UREA Slides packaged as 300 slides/pack catalog number...	Ortho-Clinical Diagnostics, Inc.	CDN	2013-06-12
Z-0300-2014	Class II	VITROS Chemistry Products BuBc Slides packaged as 300 slides/pack catalog number 8383051...	Ortho-Clinical Diagnostics, Inc.	CIG	2013-06-12
Z-0299-2014	Class II	VITROS Chemistry Products AST Slides packaged as 300 slides/pack catalog number...	Ortho-Clinical Diagnostics, Inc.	CIT	2013-06-12
Z-0298-2014	Class II	VITROS Chemistry Products AMYL Slides packaged as 300 slides/pack catalog number 1202670...	Ortho-Clinical Diagnostics, Inc.	CIW	2013-06-12
Z-0297-2014	Class II	VITROS Chemistry Products AMON Slides packaged as 300 slides/pack catalog number 1721869...	Ortho-Clinical Diagnostics, Inc.	JID	2013-06-12
Z-0296-2014	Class II	VITROS Chemistry Products ALKP Slides, 300 slides/pack; catalog number 1053180 VITROS...	Ortho-Clinical Diagnostics, Inc.	CJE	2013-06-12
Z-0295-2014	Class II	VITROS Chemistry Products ALC Slides, 90 slides/pack; catalog number 8046872 VITROS ALC...	Ortho-Clinical Diagnostics, Inc.	DMT	2013-06-12
Z-0294-2014	Class II	VITROS Chemistry Products ALB Slides, 90 slides/pack; catalog number 1988211 VITROS ALB...	Ortho-Clinical Diagnostics, Inc.	CIX	2013-06-12
Z-0293-2014	Class II	VITROS Chemistry Products AcP Slides, 90 slides/pack; catalog number 8168122 VITROS...	Ortho-Clinical Diagnostics, Inc.	CKB	2013-06-12
Z-1726-2013	Class II	Synthes CMF Distraction System The product is intended for use as a bone stabilizer and...	Synthes GmbH	MQN	2013-06-12
Z-0292-2014	Class II	VITROS Chemistry Products ACET Slides, 90 slides/pack; catalog number 1037274 VITROS...	Ortho-Clinical Diagnostics, Inc.	LDP	2013-06-12
Z-1773-2013	Class II	The LIFEPAK 500 Automated External Defibrillator is a semi-automatic defibrillator that...	Physio Control, Inc.	MKJ	2013-06-12
Z-1837-2013	Class II	Omnicycle Elite; US Importer and Distributor: Accelerated Care Plus, Reno NV...	Accelerated Care Plus Corp.	BXB	2013-06-12
Z-1564-2013	Class II	Medtronic, Launcher Guiding Catheter, Model # LA8EBU45SH, Lot # 0006722866, 8F and Model...	Medtronic, Inc.	DQY	2013-06-12
Z-1964-2013	Class II	Philips Healthcare MobileDiagnostwDR system. Mobile Digital radiography X-Ray...	Philips North America LLC	IZL	2013-06-11
Z-0063-2014	Class II	Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF...	Integra LifeSciences Corporation	GWM	2013-06-11
Z-0062-2014	Class II	Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IM3.S_.EU...	Integra LifeSciences Corporation	GWM	2013-06-11
Z-0061-2014	Class II	Integra Licox Brain Tissue Oxygen Monitoring 1 x Dual Lumen Introducer Kit REF...	Integra LifeSciences Corporation	GWM	2013-06-11
Z-0060-2014	Class II	Integra Licox Brain Tissue Oxygen Monitoring 1 x Dual Lumen Introducer Kit REF IM2_EU...	Integra LifeSciences Corporation	GWM	2013-06-11
Z-0059-2014	Class II	Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IM1.S...	Integra LifeSciences Corporation	GWM	2013-06-11
Z-0058-2014	Class II	Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IM3.SR...	Integra LifeSciences Corporation	GWM	2013-06-11
Z-0057-2014	Class II	Inegra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Tunneling Probe Kit REF...	Integra LifeSciences Corporation	GWM	2013-06-11
Z-0056-2014	Class II	Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IP2.P Rx...	Integra LifeSciences Corporation	GWM	2013-06-11
Z-0055-2014	Class II	Integra Licox Brain Tissue Oxygen Monitoring; 1 x Dual Lumen Introducer Kit REF IP2; Rx...	Integra LifeSciences Corporation	GWM	2013-06-11
Z-0054-2014	Class II	Integra Licox Brain Tissue Oxygen Monitoring; 1 x Complete Brain Probe Kit REF IP1.P Rx...	Integra LifeSciences Corporation	GWM	2013-06-11
Z-1811-2013	Class II	Sodium Bicarbonate, USP Provided bulk as raw material - label not applicable according...	Church & Dwight Co., Inc.		2013-06-11
Z-1952-2013	Class II	Synthes Flexible Medullary Reamer. Intended to be used to facilitate the preparation of...	Synthes GmbH	HTO	2013-06-11
Z-0116-2014	Class II	The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis...	GE Healthcare	LLZ	2013-06-11
Z-1675-2013	Class II	AngioDynamics RITA Main Cable, 9 Pin to 14 Pin, REF 700-101892. RITA Main Cables are...	Boston Scientific Corporation	GEI	2013-06-11
Z-1676-2013	Class II	Bigliani/Flatow The Complete Shoulder Solution, Humeral Stem Provisional 12mm x...	Zimmer GmbH	HSD	2013-06-11
Z-2301-2014	Class II	Persona (TM) The Personalized Knee System CPS Tibial Articular Surface Provisional...	Zimmer GmbH	JWH	2013-06-10
Z-2300-2014	Class II	Persona (TM) The Personalized Knee System Tibial Articular Surface Provisional...	Zimmer GmbH	JWH	2013-06-10
Z-2299-2014	Class II	Persona (TM) The Personalized Knee System UC Tibial Articular Surface Provisional...	Zimmer GmbH	JWH	2013-06-10
Z-2298-2014	Class II	Persona (TM) The Personalized Knee System CR Tibial Articular Surface Provisional...	Zimmer GmbH	JWH	2013-06-10
Z-2297-2014	Class II	Persona (TM) The Personalized Knee System Tibial Articular Surface Provisional...	Zimmer GmbH	JWH	2013-06-10
Z-2296-2014	Class II	Persona (TM) The Personalized Knee System PS Tibial Articular Surface Provisional...	Zimmer GmbH	JWH	2013-06-10
Z-0713-2014	Class II	pO2 D999 membrane units. Distributed by Radiometer America, Inc., Westlake, OH 44145 pO2...	Radiometer America, Inc	CHL	2013-06-10
Z-2208-2013	Class II	Osseotite Parallel Walled Certain 4mm(D)X 15mm (L) Dental Implant Product Usage...	ZimVie US Corp LLC	DZE	2013-06-10
Z-2207-2013	Class II	Osseotite 2 Certain Prevail 5mm(D)X 4.1mm (P) X X 11.5mm (L) Dental Implant Product...	ZimVie US Corp LLC	DZE	2013-06-10
Z-0197-2014	Class II	SIGMA SPECTRUM Infusion Pump with Master Drug Library. Intended to be used for the...	Baxter Healthcare Corporation	FRN	2013-06-10
Z-1829-2013	Class II	Cardinal BI Stat Biological Test Pack with Instant Readout Integrator, SteriTec Product...	Steritec Products Mfg. Co., Inc.	JOJ	2013-06-10