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 765 of 1190

FDA device recalls, page 765 of 1190
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-2678-2017	Class II	The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise...	Abbott Medical	FRN	2013-02-01
Z-2677-2017	Class II	The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise...	Abbott Medical	FRN	2013-02-01
Z-2676-2017	Class II	The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise...	Abbott Medical	FRN	2013-02-01
Z-2675-2017	Class II	The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise...	Abbott Medical	FRN	2013-02-01
Z-0953-2013	Class II	Optetrak Logic Comprehensive Knee Prosthesis System, Proximal Tibial Spacer and screws...	Exactech, Inc.	JWH	2013-02-01
Z-0835-2013	Class II	VACUETTE Safety Blood Collection Set + Luer Adapter, 23x12" Safety Blood Collect LA...	Greiner Bio-One North America, Inc.	FMI	2013-02-01
Z-0896-2013	Class II	Firebird Spinal Fixation System, Parallel Rod Connector (52-6800) and Axial Rod Connector...	Orthofix SRL	KWP	2013-02-01
Z-0283-2014	Class II	The Plum A+ Hyperbaric Infusion System is a cassette based multifunction infusion system...	Abbott Medical	FRN	2013-02-01
Z-1750-2013	Class II	Siemens AXIOM Artis zee/zeego systems equipped with generator A100 Plus Product...	Siemens Medical Solutions USA, Inc.	IZI	2013-01-31
Z-1559-2013	Class II	Echelon, Echelon Oval and Oasis MR imaging device systems; one unit per box. The...	FUJIFILM Healthcare Americas Corporation	LNH	2013-01-31
Z-0902-2013	Class II	Century Console Base, Model #043625051b. Intended for use as a platform for other...	Century HLM, LLC	DTQ	2013-01-31
Z-0926-2013	Class II	Medtronic O-arm Imaging System Product Usage: image-intensified fluoroscopic x-ray...	Medtronic Navigation, Inc	OXO	2013-01-31
Z-1321-2013	Class II	QIAGEN artus CMV RG PCR ASR (24) (Catalog number 4503223) Product Usage: The artus CMV...	Qiagen	LKQ	2013-01-30
Z-1320-2013	Class II	QIAGEN artus CMV RG PCR ASR (96) (Catalog number 4503225) Product Usage: Test is...	Qiagen	LKQ	2013-01-30
Z-1146-2013	Class II	Pressure Monitoring sets with VAMP Plus closed blood sampling system model # T001691A...	Edwards Lifesciences LLC	KRA	2013-01-30
Z-0868-2013	Class II	Vascular Solutions, SuperCross Microcatheter, Sterilized using ethylene oxide, Rx Only...	Vascular Solutions LLC	DQY	2013-01-29
Z-0928-2013	Class II	Isoline Implantable Defibrillation Lead, Model Isoline 2CR5, 2CR6 and 2CT6. These lead...	LivaNova USA, Inc.	MRM	2013-01-28
Z-0936-2013	Class II	Bacterin Elutia, Hubless Coated Silicone Surgical Wound Drain 24 Fr Round Hubless...	Xtant Medical Holdings, Inc.	OEI	2013-01-28
Z-0951-2013	Class II	Vial Label: 1) LIATEST VWF:Ag Buffer - 5 ml Diagnostica Stago 2) LIATEST VWF:Ag Latex +...	Diagnostica Stago, Inc.	GJT	2013-01-28
Z-0867-2013	Class II	Varian Eclipse Treatment Planning System for Radiotherapy; Model Number: H48. In...	Varian Medical Systems, Inc.	MUJ	2013-01-28
Z-0827-2013	Class II	ELECTROLASE(R) HYFRECATOR(R) ELECTRODES - BLUNT, REF/Catalog Number 7-101-8BX, Disposable...	ConMed Corporation	GEI	2013-01-28
Z-0826-2013	Class II	ELECTROLASE HYFRECATOR(R) ELECTRODES - SHARP, REF/Catalog Number 7-100-8BX, Disposable...	ConMed Corporation	GEI	2013-01-28
Z-0871-2013	Class II	Philips HeartStart XL+ Defibrillator/Monitor Model number: 861290 The HeartStart XL+ is...	Philips North America LLC	MKJ	2013-01-28
Z-1578-2013	Class II	Prism Medical C-Series Carry Bar, Class I, model number 360755. The intended use is a...	Handicare USA, Inc.	FNG	2013-01-27
Z-0822-2014	Class II	Puritan Bennett 700 Series Ventilators (PB740 and PB760) PB700 Series Operators Manual...	Medtronic, Inc.	CBK	2013-01-25
Z-0821-2014	Class II	Puritan Bennett 840 Series Ventilator PB840 Operators Manual Addendum PN 066009A...	Medtronic, Inc.	CBK	2013-01-25
Z-0875-2013	Class II	KY TINGLING JELLY Personal Lubricant. The product is packaged into 5 oz tubes with the...	Kenvue Brands LLC	NUC	2013-01-25
Z-0874-2013	Class II	KY SilkE Vaginal Moisturizer and Personal Lubricant. The product is packaged in 2.5 oz...	Kenvue Brands LLC	NUC	2013-01-25
Z-0873-2013	Class II	KY SENSITIVE TM JELLY Personal Lubricant. The product is packaged into 3 oz tubes, which...	Kenvue Brands LLC	NUC	2013-01-25
Z-1322-2013	Class II	Proplege Coronary Sinus Catheter model PR9, 11 French Introducer, kitted with PR9...	Edwards Lifesciences LLC	DWF	2013-01-25
Z-1995-2014	Class II	HLD System, Model 610, Medical Device Cleaning and High Level Disinfection...	Cenorin, LLC	LDS	2013-01-24
Z-1424-2013	Class II	User Manual addendum, TORS for da Vinci Surgical System IS 1200, IS 2000 and IS...	Intuitive Surgical, Inc.	NAY	2013-01-24
Z-1066-2013	Class II	Stelkast Cross-over Acetabular Shell and Liner Hip System, Part Numbers SC3458-52...	Globus Medical, Inc.	OQG	2013-01-24
Z-0964-2013	Class II	Howmedica Osteonics Corp. Stryker Orthopaedics Specialty Triathlon Left and Right A//P...	Howmedica Osteonics Corp	LXH	2013-01-24
Z-0917-2013	Class III	D3000I Advantage Drive System, 230v, surgical instrument motor. Product Usage: The...	Linvatec Corporation	GEY	2013-01-24
Z-0916-2013	Class III	D3000 Advantage Drive System, 115v Product Usage: The Advantage Drive Systems function...	Linvatec Corporation	GEY	2013-01-24
Z-1529-2013	Class II	USHER Support Catheter- Angled Tip WL130cm, RI 7F; REF USH07AT; PK1022-01A; Rx only...	Bard Peripheral Vascular Inc	DQY	2013-01-23
Z-1528-2013	Class II	MICROSHEATH - 0.066 (1.7mm) proximal, 0.064 (1.6mm); WL 123cm, RGC 8F Guide; minimum ID...	Bard Peripheral Vascular Inc	DQY	2013-01-23
Z-1527-2013	Class II	BARD Biopsy Systems (A Business Unit of Bard Peripheral Vascular, Inc.), UltraClip Dual...	Bard Peripheral Vascular Inc	NEU	2013-01-23
Z-1526-2013	Class II	BARD Biopsy Systems (A Business Unit of Bard Peripheral Vascular, Inc.), UltraClip Dual...	Bard Peripheral Vascular Inc	NEU	2013-01-23
Z-1479-2013	Class III	Plastic bottle containing 3.5 mL of IgG FITC Conjugate Product Usage: Product is a used...	Bion Enterprises Ltd	LJY	2013-01-23
Z-1478-2013	Class III	Plastic bottle containing 10.5 mL of IgM Conjugate Product Usage: Product is a used as a...	Bion Enterprises Ltd	GQH	2013-01-23
Z-1477-2013	Class III	Plastic bottle containing 10.5 mL of IgG Conjugate Product Usage: Product is a used as a...	Bion Enterprises Ltd	GQO	2013-01-23
Z-1344-2013	Class III	Cardinal Health hCG Cassette Rapid Test, Part Number: B1077-22 (Mfg PN: 4582105026) The...	Alere San Diego, Inc.	JHI	2013-01-21
Z-0172-2014	Class II	Artis zee systems x-ray, angiographic system	Siemens Medical Solutions USA, Inc.	IZI	2013-01-21
Z-0914-2013	Class II	Lifeguard Infusion Set with Smartsite, 20Ga, 1, CLGY-2010 Huber type needle set used for...	Vygon Mfg	FPA	2013-01-21
Z-0897-2013	Class II	Ingenuity TF PET/CT. Diagnostic imaging system	Philips North America LLC	KPS	2013-01-21
Z-0947-2013	Class II	GE Healthcare Advantx, Innova2000, Innova3100, Innova4100, Innova2100IQ, Innova3100IQ...	GE Healthcare	MQB	2013-01-21
Z-0079-2015	Class II	Medium 2-Hooks Spreader Bar for use with Loop Slings, sizes small, medium and large on...	Arjo, Inc.	FSA	2013-01-21
Z-0887-2013	Class II	Aesculap Bipolar Generator Foot Pedal, Catalog No. GK226, for electrosurgical cutting and...	Aesculap Inc	GEI	2013-01-18