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 433 of 1190

FDA device recalls, page 433 of 1190
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-0588-2019	Class II	GE LOGIQ E10 Ultrasound System, Model #530000E10. The device is intended for use by a...	GE Healthcare	IYN	2018-09-14
Z-0615-2019	Class II	Abbott i-STAT CG8+ Cartridges intended for use in the in vitro quantification of...	Abbott Medical	CHL	2018-09-13
Z-0442-2019	Class II	3.2mm Proximal Reamer/Cannulated Drill provided as part of the Fibulock Fibular Nail...	Arthrex GmbH	HTO	2018-09-13
Z-0360-2019	Class I	CoaguChek XS System Prothrombin time test: CoaguChek XS PT Test 2X24 Strips, Catalog...	Roche Diagnostics GmbH	GJS	2018-09-13
Z-0176-2019	Class II	Terumo Advanced Perfusion System 1 Electronic Patient Gas System, Catalog#: 801188	Terumo Cardiovascular Systems Corporation	DTQ	2018-09-13
Z-0367-2019	Class II	EXACTAMIX Empty EVA Bags - 3000 mL Product Usage: A plastic container used to hold...	Baxter Healthcare Corporation	KPE	2018-09-12
Z-0366-2019	Class II	EXACTAMIX Empty EVA Bags - 2000 mL Product Usage: A plastic container used to hold...	Baxter Healthcare Corporation	KPE	2018-09-12
Z-0365-2019	Class II	EXACTAMIX Empty EVA Bags - 1000 mL Product Usage: A plastic container used to hold...	Baxter Healthcare Corporation	KPE	2018-09-12
Z-0364-2019	Class II	EXACTAMIX Empty EVA Bags - 500 mL - Product Usage: A plastic container used to hold...	Baxter Healthcare Corporation	KPE	2018-09-12
Z-0363-2019	Class II	EXACTAMIX Empty EVA Bags - 250 mL Product Usage: A plastic container used to hold...	Baxter Healthcare Corporation	KPE	2018-09-12
Z-0293-2019	Class II	Technoflux IMPAK Resina lfquida acrilica elastic Curado-Calor Tipo 1, Clase 1 REF...	Cmp Industries, LLC	EBI	2018-09-12
Z-0292-2019	Class II	IMPAK Elastic Acrylic Resin Liquid Heat Cure Type 1, Class I, 1 Quart (946ml) REF:3306...	Cmp Industries, LLC	EBI	2018-09-12
Z-0238-2019	Class II	3.0mm Headless Compression Screw, Long Thread 18mm, Part Number 04.226.118 DePuy...	Synthes (USA) Products LLC	HWC	2018-09-12
Z-0207-2019	Class II	Tritanium TL Steerable Inserter, Cat. No. 48930000, UDI 07613327381900 Product...	Howmedica Osteonics Corp	LXH	2018-09-12
Z-2294-2019	Class II	TiLite X-Short anti-tip tubes, models TRA, AERO T, ZRA, AERO Z, 2GX, AERO X, Twist, and...	TiSport, LLC	IOR	2018-09-11
Z-0410-2019	Class III	R&D systems, a bio-techne brand Human Total 25-OH Vitamin D IVD ELISA Kit, REF RDKAP1971	R & D Systems, Inc.	MRG	2018-09-11
Z-0587-2019	Class II	B105/125 Patient Monitor. The device is a portable multiparameter unit to be used for...	GE Healthcare	MHX	2018-09-11
Z-0586-2019	Class II	B40i Patient Monitor and B40i Patient Monitor V3 The device is a portable multiparameter...	GE Healthcare	MHX	2018-09-11
Z-0585-2019	Class II	B20i Patient Monitor and B20i V2 Patient Monitor. The device is a portable...	GE Healthcare	MHX	2018-09-11
Z-0584-2019	Class II	PROCARE B40 Patient Monitor, V1; and B40 Patient Monitor, V2, V2.1, and V3. The PROCARE...	GE Healthcare	MHX	2018-09-11
Z-0583-2019	Class II	PROCARE B20 Patient Monitor, V1; and B20 Patient Monitor, V2. The PROCARE Monitor B20 is...	GE Healthcare	MHX	2018-09-11
Z-0388-2019	Class II	DeltaVision OMX SR Imaging System Model Number: 29115476 The DeltaVision OMX SR Imaging...	Whatman, Inc.	REM	2018-09-10
Z-0446-2019	Class II	-Outer Kit Box (P/N RFIT-LBL-0140) - FilmArray Meningitis/Encephalitis (ME) Panel REF...	BioFire Diagnostics, LLC	PLO	2018-09-10
Z-0373-2019	Class II	Sterile Knee Instruments Disposable Fluted Headless Pins, DIA 3.2mm LNTH 89mm, REF...	Howmedica Osteonics Corp	LXH	2018-09-10
Z-3260-2018	Class II	Model 3300 LATITUDE(TM) Programming System Product Usage - The Boston Scientific...	Boston Scientific Corporation	LWS	2018-09-10
Z-3259-2018	Class II	VISIONIST X4 CRT-P (Cardiac Resynchronization Therapy Pacemaker)	Boston Scientific Corporation	LWS	2018-09-10
Z-3258-2018	Class II	VALITUDE X4 CRT-P (Cardiac Resynchronization Therapy Pacemaker)	Boston Scientific Corporation	LWS	2018-09-10
Z-3257-2018	Class II	ACCOLADE Pacemaker	Boston Scientific Corporation	LWS	2018-09-10
Z-3256-2018	Class II	PROPONENT Pacemaker	Boston Scientific Corporation	LWS	2018-09-10
Z-3255-2018	Class II	ESSENTIO Pacemaker	Boston Scientific Corporation	LWS	2018-09-10
Z-2024-2021	Class II	Vivorte Trabexus EB 10 cc Bone Void Filler -Fill bone and/or defect in skeletal...	Vivorte, Inc.	MBP	2018-09-09
Z-2755-2019	Class II	APS Accelerator modular systems, 208-230 V-, 50/60 Hz, 1800 VA, IVD, RX, Class 2 Laser...	Abbott Medical	JQP	2018-09-07
Z-0038-2020	Class II	V-Twin, Catalog # 6002-800, UDI: 03661540600180 - Product Usage: An in vitro diagnostic...	VitalScientific	JJF	2018-09-07
Z-0466-2019	Class II	Dimension Vista Lipase Flex Reagent Cartridge, Model Number 10461745 Product...	Siemens Healthcare Diagnostics Inc.	CHI	2018-09-07
Z-0465-2019	Class II	Dimension Lipase Flex Reagent Cartridge, Model Number 10460277 Product Usage: Dimension...	Siemens Healthcare Diagnostics Inc.	CHI	2018-09-07
Z-0097-2019	Class II	Codan Filter (Codan catalog number BC 693) used with Medrad Patient Administration Sets...	Medrad, Inc.	FPA	2018-09-07
Z-0261-2020	Class II	Implant Direct Scan Adapter Assembly Replant platform for the following part numbers...	Implant Direct Sybron Manufacturing LLC	NDP	2018-09-06
Z-0761-2019	Class II	Heating Profile PRISMAFLO II blood return warmer for Prismaflex Product Code...	Stihler Electronic GmbH	KOC	2018-09-06
Z-0760-2019	Class II	Heating Profile PRISMAFLO II S blood return warmer for Prismaflex Product Code...	Stihler Electronic GmbH	KOC	2018-09-06
Z-0759-2019	Class II	Heating Profile PRISMAFLO II S blood return warmer for Prismaflex Product Code...	Stihler Electronic GmbH	KOC	2018-09-06
Z-0235-2019	Class II	Altrix Precision Temperature Management System Model: 8001Product Usage: The Altrix...	Stryker Medical	DWJ	2018-09-06
Z-0121-2019	Class II	CryoPatch SG Pulmonary Hemi-Artery, 1 graft	Artivion, Inc.	DXZ	2018-09-06
Z-0390-2019	Class II	Cordis POWERFLEX PRO PTA Dilatation Catheter - Product Usage: Is intended to dilate...	Cordis US Corp.	LIT	2018-09-05
Z-0296-2019	Class II	FilmArray Blood Culture Identification (BCID), IVD, Rx Only, BioFire Diagnostics, LLC...	BioFire Diagnostics, LLC	PAM	2018-09-05
Z-0103-2019	Class II	Thoratec CentriMag Motor, Model: 102956, a component of the Thoratec CentriMag Blood...	Thoratec Switzerland GmbH	KFM	2018-09-05
Z-1216-2019	Class I	Neuro Omega System, incorporating HaGuide software. For neurological and neurosurgical...	Alpha Omega Engineering Ltd.	GZL	2018-09-04
Z-0302-2019	Class II	Vereos PET/CT, Software version 2.0.1. Model Number: 882446 Product Usage: The Philips...	Philips North America LLC	KPS	2018-09-04
Z-0119-2019	Class II	McKesson Insulin Syringe 0.3mL 31GX5/16 Item Numbers: 102-SN310C31516P Product...	Cypress Medical Products LLC	FMF	2018-09-04
Z-0096-2019	Class II	GE Healthcare CARESCAPE Monitor B850 Product Usage: Intended uses of CARESCAPE B850 V2...	GE Healthcare Finland Oy	DQK	2018-09-04
Z-0095-2019	Class II	GE Healthcare CARESCAPE Monitor B450 Product Usage: Intended uses of CARESCAPE B450 in...	GE Healthcare Finland Oy	DQK	2018-09-04