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 825 of 1190

FDA device recalls, page 825 of 1190
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-0352-2012		Maquet Servo-i ventilator system Device Part number 64 87 800 Intended for treatment of...	Maquet Cardiovascular Us Sales, LLC	CBK	2011-09-19
Z-0173-2012		Baxter System 1000 Tina Single Patient Hemodialysis Delivery System; Baxter Healthcare...	Baxter Healthcare Renal Div	KDI	2011-09-19
Z-0089-2012		CORFLO 300 Enteral Pump; a volumetric rotary peristaltic intermittent enteral feeding...	Halyard Health	LZH	2011-09-19
Z-0003-2012		Cochlear Nucleus CI512 Cochlear Implant, REF Z209051, New with Nucleus 5, Sterile EO...	Cochlear Americas	MCM	2011-09-16
Z-0011-2012		Plum A+ Hyperbaric Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045...	Abbott Medical	FRN	2011-09-16
Z-0010-2012		Plum A+3 Triple Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps...	Abbott Medical	FRN	2011-09-16
Z-0009-2012		Plum A+ Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps...	Abbott Medical	FRN	2011-09-16
Z-3286-2011		Plum A+ Hyperbaric Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045...	Abbott Medical	FRN	2011-09-16
Z-3285-2011		Plum A+3 Triple Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps...	Abbott Medical	FRN	2011-09-16
Z-3284-2011		Plum A+ Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps...	Abbott Medical	FRN	2011-09-16
Z-0076-2012		MICROPLASTY TAPERLOC 7.5 MM RESECTION GUIDE, STAINLESS STEEL, BIOMET ORTHOPEDICS 56 EAST...	Zimmer GmbH	FZX	2011-09-16
Z-0523-2012		MAMMOMAT Inspiration Full field digital mammographic x-ray system	Siemens Medical Solutions USA, Inc.	MUE	2011-09-15
Z-0182-2012		Extended Brilliance Workstation-NM (EBW-NM) with software version 1.0P, 1.1.1A, 1.5H...	Philips North America LLC	LLZ	2011-09-15
Z-0148-2012		GE Healthcare Signa, Discovery and Optima. Signa HDe 1.5T; Signa Infinity TwinSpeed MR...	GE Healthcare	IWE	2011-09-15
Z-0876-2012		Alaris PC unit model 8015. The Alaris PC unit is the central programming, monitoring and...	CareFusion 303, Inc	FRN	2011-09-13
Z-1449-2012		Ref, S331140 Selex M2A Magnum Modular Head, 40 mm head diameter plus 3 mm neck,1 Taper...	Zimmer GmbH	LZO	2011-09-13
Z-0054-2012		Sarns Intracardiac Sucker, Bulk, Non-Sterile	Terumo Cardiovascular Systems Corporation	DTS	2011-09-13
Z-0053-2012		Sarns Rigid Intracardiac Sucker. The subject device is a single use, sterile device...	Terumo Cardiovascular Systems Corporation	DTS	2011-09-13
Z-1058-2013	Class I	Respironics SealFlex Single Port Ribbed Mask (Infant). For general use in respiratory...	Engineered Medical Systems, LLC	BSJ	2011-09-12
Z-0036-2012		CyberKnife Robotic Radiosurgery System, Synchrony Respiratory Tracking System (Robocouch...	Accuray Incorporated	IYE	2011-09-12
Z-0035-2012		CyberKnife Robotic Radiosurgery System, Synchrony Respiratory Tracking System (Standard...	Accuray Incorporated	IYE	2011-09-12
Z-0074-2012		CareFusion EnVe Ventilator, Model 19250-001. Manufactured by: CareFusion, 22745 Savi...	Pulmonetic Systems, Inc.	CBK	2011-09-12
Z-3275-2011		OPMI Pentero, OPMI Pentero C, OPMI Pentero 900, OPMI Vario/S8, OPMI Vario/S88, OPMI Neuro...	Carl Zeiss Meditec Inc	EPT	2011-09-12
Z-0027-2012		VARIANT II TURBO LINK Hemoglobin A1c Program Reorder Pack, 1600 tests. For the...	Bio-Rad Laboratories Inc.	LCP	2011-09-12
Z-0026-2012		VARIANT II TURBO LINK Hemoglobin A1c Program Buffer Set. Made in United States. Bio-Rad...	Bio-Rad Laboratories Inc.	LCP	2011-09-12
Z-0025-2012		VARIANT / VARIANT II B-thalassemia Short Program Elution Buffer 2,. Made in United...	Bio-Rad Laboratories Inc.	LCP	2011-09-12
Z-0024-2012		VARIANT B-thalassemia Short Program Reorder Pack, 500 Tests, For the separation and...	Bio-Rad Laboratories Inc.	LCP	2011-09-12
Z-0023-2012		VARIANT B-thalassemia Short Program Reorder Pack, 250 Tests, For the separation and...	Bio-Rad Laboratories Inc.	LCP	2011-09-12
Z-0022-2012		VARIANT II TURBO Hemoglobin A1c Program Buffer B, Made in United States. Bio-Rad...	Bio-Rad Laboratories Inc.	LCP	2011-09-12
Z-0021-2012		VARIANT II TURBO Hemoglobin A1c Program Reorder Pack, 2000 tests, IVD, Made in United...	Bio-Rad Laboratories Inc.	LCP	2011-09-12
Z-0020-2012		VARIANT II TURBO Hemoglobin A1c Program Reorder Pack, 1600 tests, IVD, Made in United...	Bio-Rad Laboratories Inc.	LCP	2011-09-12
Z-0019-2012		D-10 Hemoglobin A1c Program Elution Buffer 2: Bio-Rad Laboratories, Hercules, CA...	Bio-Rad Laboratories Inc.	LCP	2011-09-12
Z-0018-2012		D-10 Hemoglobin A1c Supplemental Reagent Pack: Bio-Rad Laboratories, Hercules, CA...	Bio-Rad Laboratories Inc.	LCP	2011-09-12
Z-0017-2012		D-10 Hemoglobin A1c Program Reorder Pack; 400 tests; For the determination of Hemoglobin...	Bio-Rad Laboratories Inc.	LCP	2011-09-12
Z-0718-2014	Class II	Anspach Single Use Sterile Bone Cutting Burs and Irrigation Clips. Rx Only	The Anspach Effort, Inc.	HTW	2011-09-09
Z-0079-2012		Medtronic Intersept Custom Tubing Pack, which are designed as specified by the user. The...	Medtronic Perfusion Systems	DXS	2011-09-09
Z-0181-2012		Varian Clinac, Trilogy, Trilogy Tx and Novalis linear accelerators. Manufactured by...	Varian Medical Systems, Inc.	IYE	2011-09-09
Z-0078-2012		Medtronic Disposable Pressure Display Set, Models 61000, 61006, 62000, 62006. Sterilized...	Medtronic Perfusion Systems	DXS	2011-09-09
Z-0052-2012		Impac Medical Systems Sequencer Product Usage: The intended us of Sequencer is to...	Elekta Limited	IYE	2011-09-09
Z-0077-2012		Medtronic Pressure Display Box, Models 66000, 64000, 63000, 60000. It is capable of...	Medtronic Perfusion Systems	DXS	2011-09-09
Z-1978-2012	Class II	Military Kit Portable Clinical Analyzer ; Abbott Point of Care, Princeton, NJ...	Abbott Medical	CHL	2011-09-08
Z-1977-2012	Class II	i-STAT1 Abaxis Analyzer; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37...	Abbott Medical	CHL	2011-09-08
Z-1976-2012	Class II	i-STAT1 Abaxis Analyzer; Abbott Point of Care, Princeton, NJ 08540	Abbott Medical	CHL	2011-09-08
Z-1975-2012	Class II	Fuso Analyzer 300F; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree...	Abbott Medical	CHL	2011-09-08
Z-1974-2012	Class II	i-Stat Portable Clinical Analyzer; Abbott Point of Care, Princeton, NJ 08540 Model 200...	Abbott Medical	CHL	2011-09-08
Z-1973-2012	Class II	iStat1 Analyzer Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree tests...	Abbott Medical	CHL	2011-09-08
Z-0846-2012		Barbiturate Enzyme Immunoassay; R1 Antibody/Substrate Reagent (5000 tests and 500...	Lin-Zhi International Inc	DIS	2011-09-08
Z-0510-2012		AVEA Ventilator (Catalog Code 17310, 17311, 17312). The AVEA is intended to provide...	Jaeger Medical GmbH	CBK	2011-09-08
Z-0048-2012		Abbott m2000rt System software; an automated system for performing fluorescence-based PCR...	Abbott Molecular, Inc.	OOI	2011-09-08
Z-0051-2012		Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used...	B Braun Medical Inc	FRN	2011-09-07