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 2026-10-22, the FDA export date. FDA medical device recall database

59,544 records, page 677 of 1191

FDA device recalls, page 677 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-0495-2015	Class II	PSI Knee System- Prosthesis, knee patellofemorotibial, semi-constrained, cemented...	Zimmer CAS	JWH	2014-11-03
Z-0872-2015	Class II	Component- Dianz Capacitor used in PerfectO2 Oxygen Concentrator, packaged one unit per...	Invacare GmbH	CAW	2014-10-31
Z-0861-2015	Class II	UroSeal Adjustable Endoscopic Valve. Model/Catalog # 00913410 The primary packaging is a...	United States Endoscopy Group, Inc.	KOG	2014-10-31
Z-0531-2015	Class II	The Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda Bioactive...	Medtronic Perfusion Systems	DTZ	2014-10-31
Z-0218-2015	Class II	CyberKnife Robotic Radiosurgery System with the first generation IRIS Variable Aperture...	Accuray Incorporated	IYE	2014-10-31
Z-1369-2015	Class II	ACCU-CHEK Connect Diabetes Management App; Instruction Manual Designed to transfer data...	Roche Diabetes Care, Inc.	JQP	2014-10-30
Z-0820-2015	Class II	CARESTREAM DIRECTVIEW CR Software Generates digital mammographic images that can be used...	Eastman Kodak Company	LLZ	2014-10-30
Z-0506-2015	Class II	INFINITI VISION SYSTEM ULTRASOUND FMS. Single-use fluid management system. STERILE...	Alcon Laboratories	HQC	2014-10-30
Z-1293-2015	Class II	Crea A and B membranes, packaged 4 per box Used in conjunction with the ABL800 FLEX...	Radiometer America, Inc	CGL	2014-10-29
Z-0485-2015	Class II	Esprit V1000 Ventilator and Esprit/V200 Conversion Ventilator The Esprit V1000 and...	Respironics, Inc.	CBK	2014-10-29
Z-0219-2015	Class II	10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM - Sterile...	Synthes GmbH	HSB	2014-10-29
Z-0449-2015	Class II	Remel TB Potassium Permanganate (.5% Aqueous) 40192, packaged in 250 ml bottles, 5/pkg...	Remel Inc	JTS	2014-10-29
Z-0523-2015	Class II	Mammomat Inspiration system: Product Usage: mammography exams, screening, diagnosis...	Siemens Medical Solutions USA, Inc.	MUE	2014-10-28
Z-0468-2015	Class II	The J700 Floor Mounted Tube Stand (FMTS) is intended to support and position the...	Summit Industries, LLC	IYB	2014-10-28
Z-0529-2015	Class II	Soft Contact Lens	COOPERVISION Manufacturing Puerto Rico, LLC	LPM	2014-10-28
Z-0981-2015	Class II	Drill set long, drill stop compatible for 4.8mm diameter implant, Article Number 040.447S...	Straumann USA, LLC	NDP	2014-10-27
Z-0801-2015	Class II	Turbo Troponin I For in vitro diagnostic use for the quantitative measurement of...	Siemens Healthcare Diagnostics Inc.	MMI	2014-10-27
Z-0579-2015	Class II	Model Number ASHA4730-01: Ambient HipVac 50 Wand with Integrated Finger Switches and...	ArthroCare Corporation	GEI	2014-10-27
Z-0488-2015	Class III	Cooper Surgical CANNULA-CURETTE 12MM; Model Number: MX562 The CooperSurgical SUCTION...	CooperSurgical, Inc.	HHK	2014-10-27
Z-0484-2015	Class II	CooperSurgical LEEP RADIUS LOOP ELECTRODE (W 2.0 cm x D 1.0 cm D, 12 cm shaft ). Box of...	CooperSurgical, Inc.	HGI	2014-10-27
Z-1395-2015	Class II	GE Discovery MR950 MRI system	GE Healthcare	IWE	2014-10-24
Z-0804-2015	Class III	Radiomat M+ NIF 14 x 17, Radiomat M+ NIF 35CM x 43CM, Radiomat M+ NIF 10 x 12, Radiomat...	AGFA Healthcare Corp.	IWZ	2014-10-24
Z-0425-2015	Class II	Relief ACP Oral Care Gel intended to relieve discomfort from dentin sensitivity. Sold...	Discus Dental LLC	LBH	2014-10-24
Z-0502-2015	Class II	The Dual Switch Valve is used for fluid drainage from the ventricles into the peritoneum...	Aesculap Inc	JXG	2014-10-24
Z-0197-2015	Class II	Integra Titan Reverse Shoulder System right and left head cutting templates, 142.5...	Integra LifeSciences Corporation	KWS	2014-10-24
Z-2316-2017	Class III	MedTest DX Assayed Human Multi Sera Control Level 1 (HNC200) and Level 2...	Horiba Instruments Incorporated	JJY	2014-10-23
Z-1680-2017	Class II	JResultNet drivers using ASTM coding language. Calculator/data processing module, for...	Data Innovations, LLC	JQP	2014-10-23
Z-1379-2015	Class II	ROTROL P Control for ROTEM delta Thromboelastometry System, Manufactured for: Tem...	TEM Systems Inc	JPA	2014-10-23
Z-0945-2015	Class II	Pacemaker Tray (Cardiovascular Surgical Instruments convenience kit)	Centurion Medical Products, LP	OFA	2014-10-23
Z-0944-2015	Class II	Diagnostic Imaging Tray (General Surgery convenience kit)	Centurion Medical Products, LP	LRO	2014-10-23
Z-0943-2015	Class II	Nerve Block Tray (Nerve Block convenience kit)	Centurion Medical Products, LP	OGJ	2014-10-23
Z-0942-2015	Class II	Chest Tube Tray (Cardiovascular Surgical Instruments convenience kit)	Centurion Medical Products, LP	OFA	2014-10-23
Z-0827-2015	Class II	Glucose Hexokinase (Liquid) Reagent For the in vitro quantitative determination of...	JAS Diagnostics/Drew Scientific	CFR	2014-10-23
Z-0226-2015	Class I	Synthes Titanium Polyaxial Reduction Head for Titanium Matrix Spine Screws: The Titanium...	Synthes (USA) Products LLC	NKB	2014-10-23
Z-0466-2015	Class II	Oxoid Legionella Latex Test, DR0800M, containing 50 tests per box. The box contains a...	Remel Inc	LIB	2014-10-23
Z-0465-2015	Class II	Oxoid Legionella Pneumo Groups 2-14 Latex Test, DR0802M, containing 50 tests per box. The...	Remel Inc	LIB	2014-10-23
Z-0463-2015	Class II	Abbott m2000sp, an automated system for performing sample preparation for nucleic acid...	Abbott Molecular, Inc.	JJH	2014-10-23
Z-0482-2015	Class II	Gateway OTW 2.75mm x 9mm; The Gateway PTA balloon catheter is indicated for balloon...	Stryker Corp.	NJE	2014-10-22
Z-0481-2015	Class II	Target 360 Standard 12mm x 30cm; Target Detachable Coils are intended to endovascularly...	Stryker Corp.	HCG	2014-10-22
Z-0480-2015	Class II	GDC-18 360 20mm x 33cm ; GDC 360 Detachable Coils are intended for embolization of those...	Stryker Corp.	HCG	2014-10-22
Z-0479-2015	Class II	GDC-10 360 10mm x 30cm SR ; GDC 360 Detachable Coils are intended for embolization of...	Stryker Corp.	HCG	2014-10-22
Z-0478-2015	Class II	GDC-10 360 SOFT 3mm x 6cm SR ; GDC 360 Detachable Coils are intended for embolization of...	Stryker Corp.	HCG	2014-10-22
Z-0958-2015	Class II	Philips Expression MR200 MRI Patient Monitoring System.	Invivo Corporation	MWI	2014-10-22
Z-1031-2015	Class II	HomeChoice/HomeChoice Pro Automated Personal Cycler, for Automated Peritoneal Dialysis...	Baxter Healthcare Corporation	FKX	2014-10-21
Z-0225-2015	Class II	The MectaLIF Oblique Handle, model number 03.22.10.0262, is used to insert the MectaLIF...	Medacta USA, Inc.	MAX	2014-10-21
Z-0419-2015	Class II	Gyrus ACMI Disposable Falope-Ring Band Applicator Kits. REF 006889-901 and REF 005280-901...	Gyrus ACMI, Inc.	KNH	2014-10-21
Z-1687-2016	Class II	Diamedix Is-EBV-EA-D IgG Test Kit Diamedix Is-Mumps IgG Test Kit is an EIA procedure...	Diamedix Corp.	GNP	2014-10-20
Z-1686-2016	Class II	Diamedix Is-EBV-VCA IgG Test Kit Diamedix Is-Mumps IgG Test Kit is an EIA procedure...	Diamedix Corp.	LSE	2014-10-20
Z-1685-2016	Class II	Diamedix Is-Mumps IgG Test Kit Diamedix Is-Mumps IgG Test Kit is an EIA procedure...	Diamedix Corp.	LJY	2014-10-20
Z-0568-2015	Class II	ASEPT 2000 ml Drainage Bag, Ref No. 622280 Product Usage: The ASEPT Drainage Bag is to...	PFM Medical GmbH	FJS	2014-10-20