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 735 of 1191

FDA device recalls, page 735 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-0216-2014	Class II	Carestream Vue PACS; Virtual PWR Reading Basic SW 8 Pack The CARESTREAM PACS is an image...	Eastman Kodak Company	LLZ	2013-09-16
Z-0215-2014	Class II	Carestream Vue PACS; Virtual PWR Reading Basic SW Workgroup The CARESTREAM PACS is an...	Eastman Kodak Company	LLZ	2013-09-16
Z-0214-2014	Class II	Carestream Vue PACS; Virtual PWR Reading Basic SW, 8 Pack The CARESTREAM PACS is an...	Eastman Kodak Company	LLZ	2013-09-16
Z-0213-2014	Class II	Carestream Vue PACS; Virtual PWR Reading Basic SW, Workgroup The CARESTREAM PACS is an...	Eastman Kodak Company	LLZ	2013-09-16
Z-0212-2014	Class II	Carestream Vue PACS; Virtual Access Plus SW, Workgroup The CARESTREAM PACS is an image...	Eastman Kodak Company	LLZ	2013-09-16
Z-0211-2014	Class II	Carestream Vue PACS; VIRTUAL ACCESS SOFTWARE, WORKGROUP The CARESTREAM PACS is an image...	Eastman Kodak Company	LLZ	2013-09-16
Z-0091-2014	Class I	Edwards Lifesciences EMBOL-X Glide Protection System; Model Numbers: EXGF24D, EXGF24LLD...	Edwards Lifesciences LLC	DWF	2013-09-16
Z-0049-2014	Class II	STAR Excimer Laser System, Model STAR S4 IR, Catalog Number: 0030-4864, Product is...	Advanced Medical Optics, Inc.	LZS	2013-09-16
Z-0048-2014	Class II	STAR Excimer Laser System with Variable Spot Scanning, Model: STAR S4, Catalog Number...	Advanced Medical Optics, Inc.	LZS	2013-09-16
Z-0047-2014	Class II	STAR ActiveTrak Excimer Laser System, Model: STAR S3, Catalog Number: 0030-2450, Product...	Advanced Medical Optics, Inc.	LZS	2013-09-16
Z-0046-2014	Class II	STAR Excimer Laser System, Model: STAR S2, Catalog Number: 0030-1479, Product is...	Advanced Medical Optics, Inc.	LZS	2013-09-16
Z-0015-2014	Class II	Product Name: OSOM C. Difficile Toxin A/B Test Catalog Numbers: 173 (for United States)...	Sekisui Diagnostics, LLC	LLH	2013-09-16
Z-0064-2014	Class II	SmartSet Endurance GMV, Gentamicin, REF 3105-040, Medium Viscosity Antibiotic Bone...	Depuy Orthopaedics Inc.	MBB	2013-09-16
Z-0168-2014	Class II	COBAS INTEGRA 800 Analyzer with software 9864.C2 Cobas. COBAS Part Numbers 28122474001...	Roche Diagnostics GmbH	JJE	2013-09-16
Z-0147-2015	Class II	Blunt Hurd Cannula Blunt Tip 10 mm with 5 mm Reducer simplifies open laparoscopy.	Lone Star Medical Products	DRC	2013-09-13
Z-0382-2014	Class II	Tri-Nex Healing Abutment, 0.50 mm x 5 mm height, Catalog No. HA-L-50-5. The NSI Implant...	Southern Implants, (Pty.) Ltd.	NHA	2013-09-13
Z-0175-2014	Class II	pH 7.0 Buffer Solution Pint and Quart Bottles, Part Number 02.0030 for Pints and 02.0031...	Mesa Laboratories Inc	JCC	2013-09-13
Z-0045-2014	Class II	Merit Medical Performa Angiographic Catheter 5F Multipack. Part numbers 7560-43 and...	Merit Medical Systems, Inc.	DQO	2013-09-13
Z-2259-2013	Class II	NX3 Try-In Gel. The product is used as a tooth shade resin material.	Sybron Dental Specialties, Inc.	EBF	2013-09-13
Z-0291-2014	Class II	Access 2 Immunoassay System, Part Number: 81600N The Access Immunoassay System is an in...	Siemens Healthcare Diagnostics Inc.	JJE	2013-09-12
Z-0050-2014	Class II	Solea 1.0 Laser Surgical instrument for use in general and plastic surgery and...	Convergent Dental	GEX	2013-09-12
Z-0082-2014	Class II	MAQUET Getinge Group CARDIOHELP Base Unit REF 70104.7999 REF 70104.8012 Manufactured for...	Maquet Cardiovascular Us Sales, LLC	DTQ	2013-09-12
Z-0486-2015	Class II	The Artis zee / zeego Angiography System is designed as a set of components that may be...	Siemens Medical Solutions USA, Inc.	IZI	2013-09-11
Z-0926-2014	Class II	The Rotoprone therapy System is an advanced patient care system for the treatment and...	Arjohuntleigh AB	IKZ	2013-09-11
Z-0906-2014	Class II	*REF 186-01-08InteGrip ACETABULAR AUGMENT**SMALL 8mm. Use with 48/50mm...	Exactech, Inc.	LPH	2013-09-11
Z-0027-2014	Class II	P21x/5-1 MHz transducer, Part Number P07698-23 Product Usage: The P21x/5-1 MHz phased...	FUJIFILM SonoSite,Inc.	IYO	2013-09-11
Z-1726-2014	Class II	Leica Ceiling Mount MS-1F & MC-1F for use with the M500 N operating microscope. Article...	Leica Microsystems, Inc.	OUE	2013-09-11
Z-1725-2014	Class II	Leica Ceiling Mount MSF-1 for use with M841 and M501 operating microscopes. Article...	Leica Microsystems, Inc.	OUE	2013-09-11
Z-0624-2014	Class II	PedFuse Bone Probe; Part: SI81008 spinal pedicle fixation.	SPINEFRONTIER, Inc. dba LESspine Innovations	HXB	2013-09-11
Z-0022-2014	Class II	Harvest Graft Delivery System; Model Number: GDP-10 Product Usage: The Harvest Graft...	Terumo BCT, Ltd	FMF	2013-09-11
Z-2594-2016	Class II	Hospira RECEPTAL LINERS: 1L(1000mL), 1.5L (1500mL), 2L (2000mL) 1) List Number 43056-01...	Abbott Medical	GCX	2013-09-10
Z-0605-2014	Class II	VERIFY Dual Species Self-Contained Biological Indicator, Distributed by STERIS...	STERIS Corporation	FRC	2013-09-10
Z-0479-2014	Class II	Aesculap GNI161 Bipolar Foot Control Product Usage: The Aesculap Bipolar Coagulator is...	Aesculap Inc	GEI	2013-09-10
Z-2593-2016	Class II	Hospira RECEPTAL CANISTERS: 1L(1000mL), 1.5L(1500mL), 2L(2000mL) Canister, ATS, 2000...	Abbott Medical	GCX	2013-09-10
Z-0358-2014	Class II	Ready to Use Thymo-Cide, Germicidal Detergent, containing 0.051% thymol, packaged in...	Wexford Labs Inc	LRJ	2013-09-10
Z-0143-2014	Class II	Dual Luer Lock Cap The device is intended for use as a cap for male or female Luer ports...	Baxter Healthcare Corporation	OBK	2013-09-10
Z-0117-2014	Class II	Brand Names: Integra Camino 110-4 Intracranial Pressure (ICP)...	Integra Lifesciences Sales LLC	GWM	2013-09-10
Z-2269-2013	Class II	Smiths Medical, Deltec: REF 21-8011-24 Port-A-Cath Dual-Lumen. Titanium Venous Access...	Abbott Medical	LJT	2013-09-10
Z-2268-2013	Class II	Smith Medical, Deltec, REF 21-2386-24, 11 Fr Introducer Set with Peel-Away Sheath...	Abbott Medical	DYB	2013-09-10
Z-2062-2016	Class II	*** 1) Product labeled in part: 19683-28; LIFESHIELD; MICRODRIP SOLUSET WITH 1.2 MICRON...	Abbott Medical	FPA	2013-09-09
Z-2061-2016	Class II	*** 1) Product labeled in part: 19734-28; LIFESHIELD; LIFESHIELD LATEX-FREE PLUM SET...	Abbott Medical	FPA	2013-09-09
Z-2060-2016	Class II	*** 1) Product labeled in part: List No. 14220-28; PLUM Y-TYPE BLOOD SET; 200 Micron...	Abbott Medical	FPA	2013-09-09
Z-2059-2016	Class II	*** 1) Product labeled in part: 14951-48; LIFESHIELD; PLUMSET WITH CONVERTIBLE PIERCING...	Abbott Medical	FPA	2013-09-09
Z-2058-2016	Class II	*** 1) Product labeled in part: List No. 14212-28; LIFESHIELD; PLUM Y-TYPE BLOOD SET; 200...	Abbott Medical	FPA	2013-09-09
Z-0028-2014	Class II	BBL (tm) MGIT (tm) Mycobacteria Growth Indicator Tube, part # 245122, packaged in 100 ct...	Becton Dickinson & Co	MDB	2013-09-09
Z-0153-2014	Class II	ISE REF Valve, Part No. MU7638 for the AU480, AU680, and AU5800 Chemistry...	Siemens Healthcare Diagnostics Inc.	JJE	2013-09-09
Z-0152-2014	Class II	ISE REF Valve, Part No. MU3226 for the AU400, AU640, AU2700, and AU5400 Chemistry...	Siemens Healthcare Diagnostics Inc.	JJE	2013-09-09
Z-1117-2014	Class II	XL CONVALESCENT RECLINER 5291/529S with Padded armrests with guard, Dual fold down...	Champion Mfg, Inc.	INM	2013-09-06
Z-1116-2014	Class II	DROP-ARM CONVALESCENT RECLINER 5271/5281 with One-touch release for drop-arms, Built-in...	Champion Mfg, Inc.	INM	2013-09-06
Z-1115-2014	Class II	CONVALESCENT RECLINER 5251/5261, 525S/526S with Side Storage Pocket, Upholstered...	Champion Mfg, Inc.	INM	2013-09-06