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 760 of 1190

FDA device recalls, page 760 of 1190
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-0350-2014	Class I	The GemStar Pump is a small and lightweight, single channel infusion device designed for...	Abbott Medical	FRN	2013-03-15
Z-1145-2013	Class II	ACIST Medical Systems Inc. The ACIST Angiographic Injection System is intended to be...	Acist Medical Systems, Inc.	DXT	2013-03-15
Z-1181-2013	Class II	Vitrea CT Brain Perfusion made available in various configurations under the names...	Canon Medical Informatics, Inc.	LLZ	2013-03-15
Z-0349-2014	Class I	The GemStar Pump is a small and lightweight, single channel infusion device designed for...	Abbott Medical	FRN	2013-03-15
Z-1110-2013	Class II	IS3000 USER MANUAL for Intuitive Surgical da Vinci Si Surgical System and da Vinci Si-e...	Intuitive Surgical, Inc.	NAY	2013-03-15
Z-1109-2013	Class II	IS2000 USER MANUAL for Intuitive Surgical da Vinci S Surgical System, Model IS2000. Arm...	Intuitive Surgical, Inc.	NAY	2013-03-15
Z-1144-2013	Class II	Vitrea CT Multi-Chamber Cardiac Functional Analysis application on Vitrea version 5.2...	Canon Medical Informatics, Inc.	LLZ	2013-03-15
Z-1070-2013	Class II	IMPAX CV Reporting Cardiac Catheterization module and IMPAX CV Outbound...	AGFA Healthcare Corp.	LLZ	2013-03-15
Z-1069-2013	Class II	IMPAX CV 7.8 SU3 - OCR Service. The IMPAX CV Reporting component facilitates the quick...	AGFA Healthcare Corp.	LLZ	2013-03-15
Z-1926-2013	Class II	Rev E PedFuse Return Screw Inserter, Part Number: 11-80030 Screw inserters are...	SPINEFRONTIER, Inc. dba LESspine Innovations	HXX	2013-03-14
Z-1111-2013	Class II	Edwards Lifesciences Duraflo coated Femoral Cannula. Product Usage: The cannulae are...	Edwards Lifesciences LLC	DWF	2013-03-14
Z-1152-2013	Class II	VITROS Chemistry Products PHBR (Phenobarbital) Slides, REF 822 1384. For the...	Ortho-Clinical Diagnostics, Inc.	DLZ	2013-03-14
Z-1072-2013	Class II	Precise Treatment Table. To be used as part of radiation therapy treatment process.	Elekta Limited	JAI	2013-03-14
Z-1127-2013	Class II	The Oxford Partial Knee; Oxford Knee Resection Procedure 3 Pack CEMENTED For use with...	Synvasive Technology, Inc.	HSD	2013-03-14
Z-1971-2013	Class II	epoc BGEM Test Card (Catalogue number CT-1004-00-00). quantitative testing of samples...	Epocal Inc	CGA	2013-03-13
Z-1367-2013	Class II	SLIDERPREP PLUS SLIDE PREPARATION CENTRIFUGE. Produce a monolayer of cells onto a glass...	Separation Technology, Inc.	IFB	2013-03-13
Z-1187-2013	Class II	Rad-8 Pulse Oximeters The Rad-8 family of pulse oximeters and accessories are indicated...	Masimo Corporation	DQA	2013-03-13
Z-1019-2013	Class II	Medtronic Archer 0.035 inch (0.89mm) Super Stiff Guidewire, Models ARCSJ200W, ARCSJ260W...	Medtronic, Inc.	DQX	2013-03-13
Z-1017-2013	Class II	Medtronic Archer Super Stiff Guidewire 0.035 inch (0.89mm), Model ARCSJ200W. Intended to...	Medtronic, Inc.	DQX	2013-03-13
Z-1122-2013	Class II	ADVIA Centaur Vitamin D Calibrator 6-pack; Reference Number:10630911. For use in the...	Siemens Healthcare Diagnostics Inc.	JIS	2013-03-13
Z-1121-2013	Class II	ADVIA Centaur Vitamin D Calibrator 2-pack; Reference Number:10493589. For use in the...	Siemens Healthcare Diagnostics Inc.	JIS	2013-03-13
Z-1120-2013	Class II	ADVIA Centaur Vitamin D Assay (500 tests); Reference Number:10631021. For use in the...	Siemens Healthcare Diagnostics Inc.	MRG	2013-03-13
Z-1119-2013	Class II	ADVIA Centaur Vitamin D Assay (100 tests); Reference Number: 10491994. For use in the...	Siemens Healthcare Diagnostics Inc.	MRG	2013-03-13
Z-2565-2014	Class II	Medsolutions4U Multi-Function Electrodes to be used with PhysioControl Lifepak...	ZOLL Medical Corporation	MKJ	2013-03-12
Z-0426-2014	Class II	Custom Ultrasonics System 83 Plus 2 and Plus 9 Endoscope Washer/Disinfector.	Wassenburg Medical B.V.	KOG	2013-03-12
Z-1488-2013	Class II	Hand Controls for Operon D750, D752, D760, D820 and D850 The hand controls are used to...	Berchtold Corp.	GDC	2013-03-12
Z-1338-2013	Class II	Brilliance CT 16-Slice Water, System Code: 728245; Brilliance CT 10-Slice Water, System...	Philips North America LLC	JAK	2013-03-12
Z-0620-2014	Class II	The Centricity Laboratory System is intended to be an information system designed to...	GE Healthcare	JQP	2013-03-12
Z-0330-2014	Class II	The Centricity Laboratory System is intended to be an information system designed to...	GE Healthcare	JQP	2013-03-12
Z-1334-2013	Class II	BBL(tm) CDC Anaerobe 5% Sheep Blood Agar. Used for culturing microorganisms.	Becton Dickinson & Co	JSG	2013-03-11
Z-1333-2013	Class II	BBL(tm) Trypticase (tm) Soy Agar with 5% Sheep Blood and MacConkey II-I Plate. Used for...	Becton Dickinson & Co	JSI	2013-03-11
Z-1332-2013	Class II	BBL(tm) Trypticase (tm) Soy Agar with 5% Sheep Blood. Used for culturing microorganisms.	Becton Dickinson & Co	JSG	2013-03-11
Z-0337-2014	Class II	Centricity Perinatal and Centricity Intensive Care is intended to be used in clinical...	GE Healthcare	HGM	2013-03-11
Z-0973-2013	Class II	PrimaConnex Tapered Implant TC, SD Internal Connection 3.5 x 10mm Catalog Number...	Keystone Dental Inc.	NDP	2013-03-11
Z-1074-2013	Class I	All OneTouch Verio IQ Blood Glucose Meters sold as: Verio IQ System Kits - Meter; Verio...	Lifescan, Inc.	NBW	2013-03-11
Z-1073-2013	Class II	Dade(R) Actin(R) FSL Activated PTT Reagent. For use in the determination of the...	Siemens Healthcare Diagnostics Inc.	GGW	2013-03-11
Z-2874-2016	Class II	LifeCare PCA 3, PCA Serial List Number 12384 Allows for clinician administration or...	Abbott Medical	MEA	2013-03-08
Z-2142-2016	Class II	The LifeCare Pump Model 4200 PCA Infuser makes possible the practical implementation of...	Abbott Medical	MEA	2013-03-08
Z-2141-2016	Class II	LifeCare PCA infusion system with Hospira MedNet software allows clinicians to...	Abbott Medical	MEA	2013-03-08
Z-2140-2016	Class II	The PCA 3 system cam be used in a wide range of clinical settings, including but not...	Abbott Medical	MEA	2013-03-08
Z-2139-2016	Class II	The LifeCare PCA Plus II infusion pump system is designed for safe, effective, analgesic...	Abbott Medical	FRN	2013-03-08
Z-0014-2014	Class II	Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies...	Synthes GmbH	HWC	2013-03-08
Z-2278-2013	Class II	Synthes 3.5 MM LCP(R) Distal Humerus System The Synthes 3.5 MM LCP Distal Humerus System...	Synthes GmbH	KTT	2013-03-08
Z-1561-2013	Class II	MEDICYCL-E- Lite Portable Oxygen System An integrated portable oxygen delivery system...	Linde Gas North America, LLC	CAN	2013-03-08
Z-1084-2013	Class II	Bracket Buccal Tube U7L DB/UL22 Roth MT HK 0/-14/0 Product Usage: Bracket Buccal...	Ormco/Sybronendo	DZD	2013-03-08
Z-0997-2013	Class II	Artis Systems with Software Artis VC20x/VC21A/VD10x that have a DSA license...	Siemens Medical Solutions USA, Inc.	IZI	2013-03-08
Z-1157-2013	Class II	APLIF Implants and Instruments, Part Numbers: 184008-10 Anterior Psoas Lumbar 18 x 40...	Spinal Solutions, LLC	MAX	2013-03-08
Z-2873-2016	Class II	LifeCare PCA Infusion System with Hospira MedNet Software, PCA Serial List Number...	Abbott Medical	MEA	2013-03-08
Z-2319-2013	Class II	DeVilbiss Vacu-Aide QSU Suction Unit (Disposable Suction Container/Filter), 800 ML DISP...	Sunrise Medical, Inc.	JCX	2013-03-07
Z-1099-2013	Class II	Torrent" irrigation tubing. Product Usage: The Torrent irrigation system (tubing and...	United States Endoscopy Group, Inc.	OCX	2013-03-07