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 2026-10-21, the FDA export date. FDA medical device recall database

59,528 records, page 718 of 1191

FDA device recalls, page 718 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-0096-2015	Class I	The GemStar Power Supply is an accessory for the GemStar Infusion Pump. It is a two piece...	Abbott Medical	FRN	2014-02-03
Z-0095-2015	Class I	The GemStar Power Supply is an accessory for the GemStar Infusion Pump. It is a two piece...	Abbott Medical	FRN	2014-02-03
Z-1501-2014	Class II	Hot Ice, 1 fl. oz., Meta Labs LLC, UPC 80705-2 Product Usage: A topical gel that...	Altasource LLC dba Meta Labs LLC	NA	2014-02-03
Z-1500-2014	Class II	Nice-En-Smooth Berry Burst, 4 oz., Manufactured by Meta Labs LLC, UPC 80604-8 Product...	Altasource LLC dba Meta Labs LLC	NA	2014-02-03
Z-1499-2014	Class II	Mega-Gen His Personal Lubricant, 8 fl. oz., Meta Labs, UPC Code 80708-3; Mega-Gen Hers...	Altasource LLC dba Meta Labs LLC	NA	2014-02-03
Z-1498-2014	Class II	Amo-O Herbal Stimulator, 2 fl. oz. Manufactured by Meta Labs, Alpharetta, GA 30076, UPC...	Altasource LLC dba Meta Labs LLC	NA	2014-02-03
Z-1317-2014	Class II	Citation TMZF HA 132 degrees Neck Angle, V40 Hip Stem - Right Size #3: catalog #...	Howmedica Osteonics Corp	MEH	2014-02-03
Z-1316-2014	Class II	IMMULITE 2000; IMMULITE 2000XPi; VersaCell The IMMULITE 2000 systems are continuous...	Siemens Healthcare Diagnostics Inc.	JJE	2014-02-03
Z-1153-2014	Class II	Treatment packs used on the VisuMax Laser Keratome. Size M Manufactured by Carl Zeiss...	Carl Zeiss Meditec Inc	HQF	2014-02-03
Z-2031-2014	Class II	GemStar infusion pump, List numbers 13000 and 13100, GemStar Infusion Pump (pain...	Abbott Medical	FRN	2014-01-31
Z-1266-2014	Class II	Otto Bock Aerial and Aerial Active Wheelchair Cushions. Material numbers: SK757...	Bock,Otto,Orthopedic Ind,Inc	IMP	2014-01-31
Z-1165-2014	Class II	MAQUET PLEGIOX Cardioplegia Heat Exchanger The PLEGIOX Cardioplegia Heat Exchanger is...	Maquet Cardiovascular Us Sales, LLC	DTR	2014-01-31
Z-1119-2014	Class I	Greatbatch Medical, Offset Cup Impactor. Part Numbers: P9485, T10243, T10281, T10287...	Greatbatch Medical	HWA	2014-01-31
Z-1456-2014	Class II	Synthes CMF Battery Powered Driver, Part no. 305.840. Used to place screws in the...	Synthes GmbH	GXL	2014-01-30
Z-1142-2014	Class II	PRE2055US: Prevena Customizable Dressing 5-Pack (US-ONLY) Product Usage: The Prevena...	KCI USA, Inc.	OMP	2014-01-30
Z-1141-2014	Class II	PRE2001US: Prevena Incision Management Customizable System Box (US-ONLY) Product...	KCI USA, Inc.	OMP	2014-01-30
Z-1140-2014	Class II	PRE2055: Prevena Customizable Dressing 5-Pack Product Usage: The Prevena Incision...	KCI USA, Inc.	OMP	2014-01-30
Z-1139-2014	Class II	PRE2001: Prevena Incision Management Customizable System Box Product Usage: The Prevena...	KCI USA, Inc.	OMP	2014-01-30
Z-1138-2014	Class II	PRE1055US: Prevena Dressing, 5 Pack (US-ONLY) Product Usage: The Prevena Incision...	KCI USA, Inc.	OMP	2014-01-30
Z-1137-2014	Class II	PRE1055: Prevena Dressing, 5 Pack Product Usage: The Prevena Incision Management System...	KCI USA, Inc.	OMP	2014-01-30
Z-1136-2014	Class II	PRE1001US: Prevena Peel and Place System Kit (US-ONLY) Product Usage: The Prevena...	KCI USA, Inc.	OMP	2014-01-30
Z-1135-2014	Class II	PRE1001: Prevena Peel and Place System Kit Product Usage: The Prevena Incision...	KCI USA, Inc.	OMP	2014-01-30
Z-1000-2014	Class II	Medtronic Intersept Custom Tubing Pack which contain Select 3D or Select CAP Arterial...	Medtronic, Inc.	DWE	2014-01-30
Z-0999-2014	Class II	Medtronic Select CAP Arterial Cannulae. Non-Vented, Carmeda Coated, model CB78722 (22...	Medtronic, Inc.	DWF	2014-01-30
Z-0998-2014	Class II	Medtronic Select CAP Arterial Cannulae. Vented, models 78818 (18 Fr.), 78820 (20 Fr.)...	Medtronic, Inc.	DWF	2014-01-30
Z-0997-2014	Class II	Medtronic Select 3D Arterial Cannulae. Vented, model 78624 (24 Fr.). Non-Vented...	Medtronic, Inc.	DWF	2014-01-30
Z-0996-2014	Class II	Medtronic Select 3D Arterial Cannulae. Vented, model 78622 (22 Fr.). Non-Vented...	Medtronic, Inc.	DWF	2014-01-30
Z-0995-2014	Class II	Medtronic Select 3D Arterial Cannulae. Vented, models 78618 (18 Fr.) and 78620 (20...	Medtronic, Inc.	DWF	2014-01-30
Z-1573-2014	Class II	SCC SA HIS version 4.0.7.0 when used with SoftMic version 4.0.7.0. SoftMic is a...	SCC Soft Computer	JQP	2014-01-29
Z-1490-2014	Class II	VITROS Chemistry Products CDM PROM (Calibration Data Module) No. 0168, Catalog Number/REF...	Ortho-Clinical Diagnostics, Inc.	JFY	2014-01-29
Z-1063-2014	Class II	Gelzone Shoulder Sleeve, Catalog Number SLV634, Lot Number 852766. Product Usage: To...	Implantech Associates Inc	HST	2014-01-29
Z-1131-2014	Class II	Accessory shorts for the AlterG Anti-Gravity treadmill. Use with the AlterG Anti-Gravity...	AlterG, Incorporated	IOL	2014-01-28
Z-1123-2014	Class II	AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002, diopter size: 16.0...	AMO Puerto Rico Manufacturing, Inc.	HQL	2014-01-28
Z-1216-2014	Class II	syngo Dynamics Picture Archiving and Communication System (PACS). Model numbers...	Siemens Medical Solutions USA, Inc.	LLZ	2014-01-27
Z-1095-2014	Class III	CSI, Diamondback 360 Coronary Orbital Atherectomy System, Part Number 70058-02, Model...	Cardiovascular Systems Incorporated	MCX	2014-01-27
Z-0992-2014	Class II	Synthes Matrix Mandible Short Threaded Drill Guide intended for oral, maxillofacial...	Synthes GmbH	FZX	2014-01-27
Z-1174-2014	Class II	Synthes Small Notch Titanium Reconstructive Plate Product Usage: The Synthes Small Notch...	Synthes GmbH	HRS	2014-01-27
Z-0986-2014	Class II	Synthes 3.2 mm Guide Wire 400mm. Used for guiding the TFN Helical Blade and TFN Lag...	Synthes GmbH	LXH	2014-01-27
Z-1154-2014	Class II	RetCam 3, RetCam Portable and RetCam Shuttle; manufactured by Clarity Medical Systems...	Clarity Medical Systems	HKI	2014-01-24
Z-1704-2014	Class II	Plum XL3 Multi line Infusion System, Micro Macro Plum XL3 Multi line Infusion System, and...	Abbott Medical	FRN	2014-01-24
Z-1703-2014	Class II	Plum XL, Micro Macro Plum XL3 with data port, and Micro Macro Plum XL with data port...	Abbott Medical	FRN	2014-01-24
Z-1702-2014	Class II	LifeCare 5000 Pump (Plum 1.6) infusion pump, indicated for volumetric infusion of...	Abbott Medical	FRN	2014-01-24
Z-1112-2014	Class II	Oxoid Legionella BCYE Growth Supplement, For 500 ml of medium, SR0110C, packaged 10...	Remel Inc	JSK	2014-01-24
Z-1073-2014	Class II	NxStage PureFlow-B Solution; Model/Catalog Number: RFP-401. Product is packaged in a...	NxStage Medical Inc	KPO	2014-01-24
Z-1094-2014	Class II	NovaSure Impedance Controlled Endometrial Ablation System Radiofrequency Controller...	Hologic, Inc.	MNB	2014-01-24
Z-1128-2014	Class II	Model Kodak 2200 Intraoral X-Ray System, Catalog Numbers 5303177, 5303169, 5303151...	Eastman Kodak Company	EHD	2014-01-24
Z-1127-2014	Class II	Model Kodak 2100 Intraoral X-Ray System, Catalog Numbers 5303144, 8011579 -- Carestream...	Eastman Kodak Company	EHD	2014-01-24
Z-1107-2014	Class II	Philips HeartStart XL+ Defibrillator/Monitor Model: 861290 The HeartStart XL+ is...	Philips North America LLC	MKJ	2014-01-24
Z-1209-2014	Class II	Reusable Clip Applier Manufactured by AtriCure, Inc., 6217 Centre Park Drive, West...	AtriCure, Inc.	HBT	2014-01-23
Z-1066-2014	Class II	Reflection Interfit Shell, 52 MM OD, 3 HOLE, REF 71336052, QTY 1, STERILE R, Smith &...	Smith & Nephew, Inc.	MBL	2014-01-23