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 791 of 1190

FDA device recalls, page 791 of 1190
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-2238-2012	Class II	Horizon Medical Imaging system. Product Usage: Horizon Medical Imaging is a medical...	Change Healthcare Canada Company	LLZ	2012-05-29
Z-2242-2012	Class II	EasyLink Informatic System is included with the Dimension Vista System. The Dimension...	Siemens Healthcare Diagnostics Inc.	JQP	2012-05-29
Z-2210-2012	Class II	Maquet Getinge Group Pediatric Arterial Cannula Maquet Cardiopulmonary AG Kehler Strabe...	Maquet Cardiovascular Us Sales, LLC	NCP	2012-05-29
Z-2445-2012	Class III	Trinity Biotech, Captia VZV IgG. Product code 2325600: 96 Tests; product code: 2325601...	Trinity Biotech USA	GQX	2012-05-29
Z-2470-2012	Class II	This voluntary medical device correction is related to Alcon products that present a 23G...	Alcon Laboratories	NGY	2012-05-29
Z-1902-2012	Class II	MULTIGENT Acetaminophen for use with Architect/Aeroset Cat. No. 2K99-20. Assay is...	Sekisui Diagnostics, LLC	LDP	2012-05-29
Z-1936-2012	Class II	Microbiologics 217 Osseo Avenue North, St. Cloud, MN 56303, Gram Stain Control Slides...	Microbiologics, Inc.	LJG	2012-05-29
Z-1901-2012	Class I	AirLife Isothermal Breathing Circuit Accessory - Infant Patient Y Connector; an Rx device...	Medtronic, Inc.	BZE	2012-05-29
Z-1900-2012	Class I	AirLife Isothermal Breathing Circuit, Infant Respiratory Circuit, Non-Heated; an Rx...	Medtronic, Inc.	BZE	2012-05-29
Z-1899-2012	Class I	AirLife Isothermal Breathing Circuit, Infant Respiratory Circuit, Heated; an Rx device...	Medtronic, Inc.	BZE	2012-05-29
Z-0560-2013	Class II	Advantage Workstation Volume Share 2 (versionAW4.4_04) with Volume Viewer 3 and 3.1...	GE Healthcare	LLZ	2012-05-29
Z-0901-2013	Class II	GE Healthcare Volume Viewer Plus 5.x (Advantage Workstation 4.2) Volume Viewer 3.x...	GE Healthcare	JAK	2012-05-25
Z-2076-2012	Class I	Alaris PC unit model 8015 Product Usage: The device is labeled for prescription use...	CareFusion 303, Inc	FRN	2012-05-25
Z-2079-2012	Class II	Getinge brand --- large capacity, floor loading jet spray, washers for mechanical...	Getinge USA, Inc.	MEC	2012-05-25
Z-1822-2012	Class II	Peak SE Primer Kits (4 syringes per kit) manufactured by Ultradent Products, Inc, South...	Ultradent Products Inc.	KLE	2012-05-24
Z-2023-2012	Class II	EkoSonic MACH4 Endovascular Device (Catalog #500-55106, 500-55112; 500-55118; 500-55124...	EKOS Corporation	KRA	2012-05-24
Z-2203-2012	Class II	GE Healthcare Advantage Workstations, Advantage Worksation version 4.2 and 4.3 with...	GE Healthcare	LLZ	2012-05-24
Z-0125-2013	Class II	GE Healthcare, Seno Advantage 2.2 workstations with software version 22_01 and 22_02 A...	GE Healthcare	LLZ	2012-05-24
Z-0754-2013	Class II	AdvantageSim MD versions 7.4 through 7.6, Model 5160092-2 Version 7.4, 5160092-3 Version...	GE Healthcare	KPQ	2012-05-24
Z-0095-2013	Class II	GE Seno Advantage 1.x, Seno Advantage 2.0, Seno Advantage 2.1 Seno Advantage 1.x, Seno...	GE Healthcare	LLZ	2012-05-24
Z-1960-2012	Class II	GE Advantage CT/PET Fusion for Advantage Windows Workstation with Volume View CT...	GE Healthcare	LLZ	2012-05-24
Z-2028-2012	Class II	Integra(TM) Jarit(R) Take-Apart Endoscopic Instruments. Integra(TM) Jarit(R) Take-Apart...	Integra Lifesciences Sales LLC	KNF	2012-05-23
Z-2022-2012	Class II	LMA Esophageal Intubation Detector (EID), Catalog Number EID100 The device is used to...	LMA North America Inc	BTR	2012-05-23
Z-2011-2012	Class II	Bipolar Forceps model number: S02-XXX, S03-XXX, P02-XXX, and P03-XXX. "Instructions For...	Stingray Surgical Products	GEI	2012-05-23
Z-1988-2012	Class II	Intellispace Portal software. Intellispace Portal is a multimodality thin client...	Philips North America LLC	JAK	2012-05-23
Z-1987-2012	Class II	IntelliSpace Portal software and Extended Brillance Workspace software Intellispace...	Philips North America LLC	JAK	2012-05-23
Z-0035-2013	Class II	TetraCXP Software System, Part Number A40051. Allows simultaneous identification and...	Siemens Healthcare Diagnostics Inc.	GKZ	2012-05-22
Z-0034-2013	Class II	CYTO-STAT tetraCHROME CD45- FITC/CD56-RD1/CD19-ECD/CD3-PC5, Part Number 6607073. Allows...	Siemens Healthcare Diagnostics Inc.	GKZ	2012-05-22
Z-0033-2013	Class II	CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5, Part Number 6607013. Allows...	Siemens Healthcare Diagnostics Inc.	GKZ	2012-05-22
Z-2320-2012	Class II	BD GeneOhm VanR Assay , Catalog # 441250, 5 box tests labeled in part***GeneOhm Sciences...	Becton Dickinson & Co		2012-05-22
Z-2319-2012	Class II	BD GeneOhm Cdiff Assay , Catalog # 441401, 200 box tests 2-3 labeled in part***GeneOhm...	Becton Dickinson & Co	LLH	2012-05-22
Z-2318-2012	Class II	BD GeneOhm Cdiff Assay , Catalog #441400 200, box tests 1-3 labeled in part***BD...	Becton Dickinson & Co	LLH	2012-05-22
Z-2317-2012	Class II	BD GeneOhm MRSA ACP Assay, Catalog #441639, box 200 tests labeled in part***GeneOhm...	Becton Dickinson & Co	NQX	2012-05-22
Z-2316-2012	Class II	BD GeneOhm MRSA ACP Assay Catalog #441637, box 48 tests labeled in part***GeneOhm...	Becton Dickinson & Co	LLH	2012-05-22
Z-2060-2012	Class II	4.5mm TI Multiloc Screw Length 28MM-Sterile Expiration: 04/29/2012 REF...	Synthes GmbH	HSB	2012-05-22
Z-2059-2012	Class II	4.5mm TI Multiloc Screw Length 38MM-Sterile Expiration: 04/29/2012 REF...	Synthes GmbH	HSB	2012-05-22
Z-2000-2012	Class II	Intellispace Portal software Product Usage: Intellispace Portal is a multimodality...	Philips North America LLC	JAK	2012-05-22
Z-1932-2012	Class I	Triage D-dimer PN 98100 Used as an aid in the assessment and evaluation of patients...	Alere San Diego, Inc.	GHH	2012-05-22
Z-1931-2012	Class I	Alere Triage BNP PN 98000XR Intended to be used as an aid in the diagnosis and...	Alere San Diego, Inc.	NBC	2012-05-22
Z-1930-2012	Class I	Alere Triage Profiler SOB Panel PN 97300 Used for the determination of creatine kinase...	Alere San Diego, Inc.	DAP	2012-05-22
Z-1929-2012	Class I	Alere Triage Cardiac Panel PN 97000HS Used for the quantitative determination of...	Alere San Diego, Inc.	NBC	2012-05-22
Z-1928-2012	Class I	Alere Triage CardioProfiler Panel PN 97100CP Used for the quantitative determination of...	Alere San Diego, Inc.	NBC	2012-05-22
Z-1818-2012	Class II	Philips Digital Diagnost Software, software release 2.0.2 and 2.0.2SP1 including mirror...	Philips North America LLC	MQB	2012-05-22
Z-1705-2012		Product is the Spacelabs Medical Xprezzon Bedside Monitor, Model 91393. The Xprezzon...	GE Healthcare	MHX	2012-05-22
Z-1829-2012	Class II	Philips Multi Diagnost Eleva II with swivel cable Product Codes; 708032, 708036 Multi...	Philips North America LLC	IZI	2012-05-21
Z-1866-2012	Class II	Formula Shaver Handpiece (with buttons); Formula 180 Shaver Handpiece (with button) Rx...	Stryker Corp.	GFA	2012-05-21
Z-1843-2012	Class II	Olympic Cool-Cap System is intended to provide treatment for neonatal hypoxic-ischemic...	Natus Medical Incorporated	MXM	2012-05-21
Z-2068-2012	Class II	VITROS 5600 Integrated System Software For use in the in-vitro quantitative, semi...	Ortho-Clinical Diagnostics, Inc.	JJE	2012-05-21
Z-2067-2012	Class II	VITROS 4600 Chemistry System Software For use in the in-vitro quantitative, semi...	Ortho-Clinical Diagnostics, Inc.	JJE	2012-05-21
Z-2066-2012	Class II	VITROS 5,1 FS System Software For use in the in-vitro quantitative, semi quantitative...	Ortho-Clinical Diagnostics, Inc.	JJE	2012-05-21