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 768 of 1190

FDA device recalls, page 768 of 1190
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-0733-2013	Class II	UltraClean(R) Accessory Electrode 6 inch Coated Blade, REF/Catalog No. 139107, Single...	ConMed Corporation	GEI	2012-12-27
Z-0732-2013	Class II	UltraClean(R) Accessory Electrode 1 inch Coated Needle with Extended Insulation...	ConMed Corporation	GEI	2012-12-27
Z-0731-2013	Class II	UltraClean(R) Accessory Electrode 1 inch Coated Blade with Extended Insulation...	ConMed Corporation	GEI	2012-12-27
Z-0730-2013	Class II	UltraClean(R) Accessory Electrode 1 inch Coated Needle, REF/Catalog No. 139102, Single...	ConMed Corporation	GEI	2012-12-27
Z-0729-2013	Class II	UltraClean(R) Accessory Electrode, 1 inch Coated Blade, REF/Catalog No. 139100, Single...	ConMed Corporation	GEI	2012-12-27
Z-0728-2013	Class II	Electrosurgical Tip Cleaner, REF/Catalog No. 138029, Single Use, Sterile, Rx ONLY...	ConMed Corporation	GEI	2012-12-27
Z-0727-2013	Class II	ELECTROSURGICAL ENT NEEDLE ELECTRODE, 6 inch with Extended Insulation, REF/Catalog No...	ConMed Corporation	GEI	2012-12-27
Z-0726-2013	Class II	CONMED(R) ELECTROSURGICAL SAFETY HOLSTER, Disposable Safety Holster, REF/Catalog No...	ConMed Corporation	GEI	2012-12-27
Z-0725-2013	Class II	TUR/Endoscopic Cable, 10 feet (3.05 mm), REF/Catalog No. 135171, Disposable, Sterile, Rx...	ConMed Corporation	GEI	2012-12-27
Z-0724-2013	Class II	ABC(R) NOZZLE, Single Patient Use Nozzle, (For use with 130500 Reusable ABC(R)...	ConMed Corporation	HAM	2012-12-27
Z-0723-2013	Class II	Goldvac(TM) UltraClean(R) Accessory Electrode 6 inch Coated Blade, REF/Catalog No...	ConMed Corporation	GEI	2012-12-27
Z-0722-2013	Class II	Goldvac(TM) UltraClean(R) Accessory Electrode 4 inch Coated Blade, REF/Catalog No...	ConMed Corporation	GEI	2012-12-27
Z-0721-2013	Class II	Goldvac(TM) UltraClean(R) Accessory Electrode 6 inch Coated Blade with Extended...	ConMed Corporation	GEI	2012-12-27
Z-0720-2013	Class II	Goldvac(TM) UltraClean(R) Accessory Electrode 1 inch Coated Blade with Extended...	ConMed Corporation	GEI	2012-12-27
Z-0719-2013	Class II	ELECTROLASE(R) HYFRECATOR(R) ELECTRODES - BLUNT, Disposable Hyfrecator(R) Tips...	ConMed Corporation	GEI	2012-12-27
Z-0718-2013	Class II	ELECTROLASE(R) HYFRECATOR(R) ELECTRODES - SHARP, Disposable Hyfrecator(R) Tips...	ConMed Corporation	GEI	2012-12-27
Z-0839-2013	Class II	Maquet ELS Cannula 15 FR. Used for extracorporeal membrane oxygenation (ECMO) for the...	Maquet Cardiovascular Us Sales, LLC	DWF	2012-12-26
Z-0738-2013	Class II	BacT/ALERT SA Blood Culture Bottle. The BacT/ALERT SA reagent bottle is intended to be...	bioMerieux, Inc.	MDB	2012-12-25
Z-2045-2018	Class II	nordicBrainEX Product Usage: nordicBrainEx is an image processing software package to be...	NordicNeuroLab AS	LLZ	2012-12-21
Z-1336-2013	Class II	ACUVUE ADVANCE Brand Contact Lenses with HYDRACLEAR, Soft, disposable contact...	Johnson & Johnson Vision Care, Inc.	LPL	2012-12-21
Z-1335-2013	Class II	1-DAY ACUVUE MOIST Brand Contact Lenses, soft disposable contact lenses. The Vistakon...	Johnson & Johnson Vision Care, Inc.	LPL	2012-12-21
Z-0869-2013	Class II	MAYFIELD Composite Series Base Unit Standard, Model (A3101), Rx ONLY, Integra...	Integra LifeSciences Corporation	FWZ	2012-12-21
Z-0793-2013	Class III	OPTIGEN Food 30; Catalog number: 85035. For allergen testing. Manufactured by Hitachi...	Canon Medical Diagnostics USA, Inc.	DHB	2012-12-21
Z-0945-2013	Class II	Brilliance 6, 10, 16, 40, 64, Big Bore and the iCT, iCT SP, Ingenuity CT and MX8000 Dual...	Philips North America LLC	JAK	2012-12-20
Z-1029-2013	Class II	Ingenuity TF PET/CT. Diagnostic imaging system that combines Positron Emission...	Philips North America LLC	KPS	2012-12-20
Z-0919-2013	Class II	Command Instrument Broach Handle. Used in Total Hip Arthroplasty. Catalog Number...	Howmedica Osteonics Corp	LXH	2012-12-20
Z-0832-2013	Class II	CareFusion SmartSite Gravity Blood Set Model 42082E. Used to administer blood and blood...	CareFusion 303, Inc	FPA	2012-12-20
Z-0745-2013	Class III	Dimension(R) IRON Calibrator (DC85), Siemens material number 10445010. The Dimension(R)...	Siemens Healthcare Diagnostics Inc.	JIS	2012-12-20
Z-0933-2013	Class III	Siemens Total Iron Binding Capacity (IBCT) Flex Reagent Cartridge. An in vitro...	Siemens Healthcare Diagnostics Inc.	JMO	2012-12-20
Z-0929-2013	Class II	AMO Sensar Intraocular Lenses (IOLs), Model AR40e, Sensar Foldable IOL with OptiEdge...	Advanced Medical Optics, Inc.	HQL	2012-12-20
Z-0715-2013	Class II	Medisystems 17 Gauge x 1" inch AV Fistula Needle Product Code: D9-2007MGLB Product...	NxStage Medical Inc	FIE	2012-12-20
Z-1077-2013	Class II	ELEKTA MOSAIQ SW version below 2.41 Product Usage: The intended use of the SIEMENS...	Siemens Medical Solutions USA, Inc.	IYE	2012-12-20
Z-0714-2013	Class II	Medisystems 15 Gauge x 3/5 inch Buttonhole Needle Set Product Code: BH-2035PE Product...	NxStage Medical Inc	FIE	2012-12-20
Z-0655-2013	Class II	FlowGate Balloon Guide Catheter; Manufactured by Concentric Medical, Mountain View...	Concentric Medical, Inc.	DQY	2012-12-20
Z-0825-2013	Class II	HealthTronics Endocare 3.8mm RenalCryo Cryoprobe, R3.8L. The Endocare CryoProbe is an...	Varian Medical Systems, Inc.	GEH	2012-12-20
Z-0017-2014	Class II	Dimension Vista (R) Urinary/Cerebrospinal Fluid Protein (UCFP) Flex (R) Reagent Cartridge...	Siemens Healthcare Diagnostics Inc.	JGQ	2012-12-19
Z-0899-2013	Class II	Philips MX 16-Slice CT Scanner System, a whole-body computed tomography X-ray system.	Philips North America LLC	JAK	2012-12-19
Z-0931-2013	Class II	Elekta Synergy XVI. Radiation Therapy Digital Imager. Product XVI R3.5.1, R4.2.1, and...	Elekta Limited	IYE	2012-12-19
Z-0741-2013	Class I	HAMILTON-T1 Ventilator with software versions 1.1.2 or lower. The HAMILTON T-1...	Hamilton Medical AG	CBK	2012-12-19
Z-2177-2013	Class II	Surgical microscope The device is used to improve the visibility of objects through...	Leica Microsystems (Schweiz) AG	FSO	2012-12-18
Z-2176-2013	Class II	Surgical microscope The device is used to improve the visibility of objects through...	Leica Microsystems (Schweiz) AG	FSO	2012-12-18
Z-0892-2013	Class I	Ad-Tech Medical Instrument Corporation Macro Micro Subdural Electrode. For temporary...	AD-Tech Medical Instrument Corp.	GYC	2012-12-18
Z-0986-2013	Class II	Needle Counters with Blade Disarmer; 12.2 x 10.5 x 3.5 cm; 60 Count/100 Capacity...	Medtronic, Inc.	FSM	2012-12-18
Z-0985-2013	Class II	Needle Counters with Blade Disarmer; 12.2 x 10.5 x 3.5 cm; 40 Count/70 Capacity; Sterile...	Medtronic, Inc.	FSM	2012-12-18
Z-0984-2013	Class II	Needle Counters; 12.2 x 10.5 x 3.5 cm; 40 Count/80 Capacity; Sterile; Double Removable...	Medtronic, Inc.	FSM	2012-12-18
Z-0983-2013	Class II	Needle Counters; 12.2 x 10.5 x 3.5 cm; 40 Count/70 Capacity; Sterile; Removable Numbered...	Medtronic, Inc.	FSM	2012-12-18
Z-0982-2013	Class II	Needle Counters with Blade Disarmer; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capacity; Sterile...	Medtronic, Inc.	FSM	2012-12-18
Z-0981-2013	Class II	Needle Counters; Sterile; Foam Strip; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capacity...	Medtronic, Inc.	FSM	2012-12-18
Z-0980-2013	Class II	Needle Counters with Blade Disarmer; 11.5 x 6.5 x 3.3 cm; 15 Count/30 Capacity; Sterile...	Medtronic, Inc.	FSM	2012-12-18
Z-0979-2013	Class II	Needle Counters with Blade Disarmer; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacity; Sterile...	Medtronic, Inc.	FSM	2012-12-18