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 789 of 1190

FDA device recalls, page 789 of 1190
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-2338-2012	Class III	STERRAD NX Cassette, Batch # 12A078. The STERRAD 100S and STERRAD NX sterilizations...	Advanced Sterilization Products	MLR	2012-06-19
Z-2337-2012	Class III	STERRAD 100S Cassette, Batch # 12A077. The STERRAD 100S and STERRAD NX sterilizations...	Advanced Sterilization Products	MLR	2012-06-19
Z-2072-2012	Class II	EOS X-ray Medical Diagnostic , X-ray Equipment System Digital Radiography used in...	EOS imaging	MQB	2012-06-19
Z-2006-2012	Class I	CareFusion EnVe Ventilator Designed for use on patients who require respiratory support...	Pulmonetic Systems, Inc.	CBK	2012-06-19
Z-1961-2012	Class II	Stryker brand Arthroscope and Hardware Set Tray (sterilization tray); Model/Part Number...	Stryker Corp.	GEI	2012-06-19
Z-2330-2018	Class II	Safe N Simple No-Sting Skin Barrier Film, Ostomy Skin Barrier Wipe, SNS00807	Safe N Simple, LLC	NEC	2012-06-18
Z-0001-2013	Class II	MIRS for MATRIX Spine System. Minimally Invasive Reduction Screw (MIRS) for percutaneous...	Synthes GmbH	NKB	2012-06-18
Z-2041-2012	Class II	Varian brand Varian Eclipse Treatment Planning System for radiotherapy; Model Number...	Varian Medical Systems, Inc.	MUJ	2012-06-18
Z-1959-2012	Class II	CSI Stealth 360-degree Orbital Atherectomy Device (OAD), Part Number 70056-11, Model...	Cardiovascular Systems Incorporated	MCW	2012-06-18
Z-2001-2012	Class II	superDimension Systems AAS00016-xx with Software Version 4.0-4.9. Indicated for use for...	Medtronic, Inc.	OGK	2012-06-18
Z-1864-2012	Class II	Advanta 2 Bed. The Advanta 2 Bed is intended for low to moderate acuity patients in the...	Hill-Rom Inc.	FNL	2012-06-18
Z-2052-2012	Class II	Sarns Modular Perfusion System 9000, 100V with color screen. The Sarns Perfusion System...	Terumo Cardiovascular Systems Corporation	DTQ	2012-06-18
Z-2051-2012	Class II	Sarns Modular Perfusion System 9000, 220/240V with color screen. The Sarns Perfusion...	Terumo Cardiovascular Systems Corporation	DTQ	2012-06-18
Z-2050-2012	Class II	Sarns Modular Perfusion System 9000, 115V with color screen. The Sarns Perfusion System...	Terumo Cardiovascular Systems Corporation	DTQ	2012-06-18
Z-2049-2012	Class II	Sarns Modular Perfusion System 8000 base, 5 pump 100V. he Sarns Modular Perfusion System...	Terumo Cardiovascular Systems Corporation	DTQ	2012-06-18
Z-2048-2012	Class II	Sarns Modular Perfusion System 8000 base, 4 pump 100V. The Sarns Modular Perfusion...	Terumo Cardiovascular Systems Corporation	DTQ	2012-06-18
Z-2047-2012	Class II	Sarns Modular Perfusion System 8000 base, 5 pump 220/240V. The Sarns Modular Perfusion...	Terumo Cardiovascular Systems Corporation	DTQ	2012-06-18
Z-2046-2012	Class II	Sarns Modular Perfusion System 8000 base, 4 pump 220/240V. The Sarns Modular Perfusion...	Terumo Cardiovascular Systems Corporation	DTQ	2012-06-18
Z-2045-2012	Class II	Sarns Modular Perfusion System 8000 base, 5 pump 115V. The Sarns Modular Perfusion...	Terumo Cardiovascular Systems Corporation	DTQ	2012-06-18
Z-2044-2012	Class II	Sarns Modular Perfusion System 8000 base, 4 pump 115V. The Sarns Modular Perfusion...	Terumo Cardiovascular Systems Corporation	DTQ	2012-06-18
Z-2043-2012	Class II	Terumo Advanced Perfusion System 1. System 1 base 220/240V. The Terumo Advanced...	Terumo Cardiovascular Systems Corporation	DTQ	2012-06-18
Z-2042-2012	Class II	Terumo Advanced Perfusion System 1. System 1 base 100/120V. The Terumo Advanced...	Terumo Cardiovascular Systems Corporation	DTQ	2012-06-18
Z-2008-2012	Class II	Custom surgical kits and trays: GEO-MED TOTAL KNEE PACK PGYBK, REF 89-6664.04 GEO-MED...	DeRoyal Industries, Inc.	LRO	2012-06-16
Z-0118-2014	Class II	Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives...	GE Healthcare	LLZ	2012-06-15
Z-0252-2013	Class II	STA Satellite Automated Multi-Parameter Analyzer This system is a fully automatic...	Diagnostica Stago, Inc.	JPA	2012-06-15
Z-2254-2012	Class II	Hitachi Echelon MRI System/Oasis MRI, Software. These are software controlled MRI...	FUJIFILM Healthcare Americas Corporation	LNH	2012-06-15
Z-2205-2012	Class I	Alaris Pump Module Model 8100 (formerly Medley Pump Module) Subsequent Product Code...	CareFusion 303, Inc	FRN	2012-06-15
Z-2120-2012	Class II	Octane-C Cervical, 6 Lordotic Intended for anterior cervical spine intervertebral body...	Exactech, Inc.	ODP	2012-06-15
Z-2119-2012	Class II	Equinoxe Reverse Glenosphere Locking Screw Intended for Primary and Reverse Total...	Exactech, Inc.	KWT	2012-06-15
Z-2118-2012	Class II	Equinoxe Reverse Shoulder Fracture Adapter Tray Screw Intended for Primary and Reverse...	Exactech, Inc.	KWS	2012-06-15
Z-2117-2012	Class II	Equinoxe Reverse Compression Screw Intended for Primary and Reverse Total Shoulder...	Exactech, Inc.	KWT	2012-06-15
Z-2116-2012	Class II	Equinoxe Fixed Angle Replicator Plate Intended for Primary and Reverse Total Shoulder...	Exactech, Inc.	KWS	2012-06-15
Z-2115-2012	Class II	Equinoxe Anatomic Replicator Plate Intended for Primary and Reverse Total Shoulder...	Exactech, Inc.	KWS	2012-06-15
Z-2180-2012	Class II	AngioDynamics Angiographic catheter --- Soft-Vu (JB-1) Non-braided. --- Size: 5F; Length...	Angiodynamics Worldwide Headquarters	DQO	2012-06-15
Z-1951-2012	Class II	AEM Disposable Electrodes, Device, Electrosurgical, Cutting and Coagulation and...	Encision, Inc.	GEI	2012-06-15
Z-2381-2012	Class II	The 2.7mm Drilling Guide is a reusable instrument used in conjunction with a drill to...	Integra LifeSciences Corporation	FZX	2012-06-14
Z-2057-2012	Class II	OrthoPediatrics PediLoc Locking Plate System, 4.5mm Contour Locking Compression Femur 8...	Orthopediatrics Corp	HRS	2012-06-14
Z-1942-2012	Class II	Philips Xcelera Connect, Software R2.1 L 1 SP2, an interface engine for data...	Philips North America LLC	OUG	2012-06-14
Z-0814-2013	Class II	GE Healthcare, Dash Port 2 Docking Station. Product Usage: is a docking station (quick...	GE Healthcare	MHX	2012-06-13
Z-0813-2013	Class II	GE Healthcare, Dash 3000, Dash 4000 and Dash 5000 Physiological Patient Monitor and...	GE Healthcare	MHX	2012-06-13
Z-1856-2012	Class II	seprafilm Single Site ADHESION BARRIER Re-order Number: 6641-01 Product Usage: Seprafilm...	Genzyme Corporation	MCN	2012-06-13
Z-1855-2012	Class II	seprafilm Procedure Pack ADHESION BARRIER Re-order Number: 5086-02 Product...	Genzyme Corporation	MCN	2012-06-13
Z-2695-2014	Class II	Fuze Manual Tilt Wheelchair. Fuze T50, Fuze T20 and Fuze T50 Jr	Pdg Product Design Group Inc	IOR	2012-06-12
Z-0160-2013	Class II	QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator; QUADROX-i ADULT HMO 70000 / HMO...	Maquet Cardiovascular Us Sales, LLC	DTZ	2012-06-12
Z-2019-2012	Class II	Spacelabs Medical Xprezzon Bedside Monitor, Model 91393, installations with Option C. It...	GE Healthcare	MHX	2012-06-12
Z-2202-2012	Class II	Carestream DRX-1 System Battery --- Made in U.S.A. for Carestream Health, Inc...	Eastman Kodak Company	MQB	2012-06-12
Z-2036-2012	Class II	Hudson RCI Concha Therm Neptune Humidifier, Rx Only, Product Usage: Usage: Device that...	Teleflex Medical	BTT	2012-06-12
Z-2015-2012	Class II	GE Healthcare, Invasive Blood Pressure Care Cables. Product ID Number: 2016995-001...	GE Healthcare	MHX	2012-06-12
Z-0632-2014	Class II	Anspach B-Blue-S 11.25 cm attachment and Anspach B-Green Standard Craniotome. Cutting...	The Anspach Effort, Inc.	GFF	2012-06-11
Z-0631-2014	Class II	Anspach BLACKMAX-N (Pneumatic motor) and Autolube III (Foot Control). Cutting and...	The Anspach Effort, Inc.	GEY	2012-06-11