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 2026-10-19, the FDA export date. FDA medical device recall database

59,528 records, page 729 of 1191

FDA device recalls, page 729 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-0488-2014	Class I	1) Nephros SafeShower FH - 15 filters per box; item no. 70-0236 2) Nephros SafeShower HH...	Nephros Inc	ND	2013-10-28
Z-0487-2014	Class I	Nephros SafeSpout Manufacturer: Nephros Inc. 41 Grand Avenue, River Edge, NJ...	Nephros Inc	ND	2013-10-28
Z-0490-2014	Class I	Nephros Dual Stage Ultra Filter (DSU) Brochure Document 60-3003 Revisions: 0, 1...	Nephros Inc		2013-10-28
Z-0201-2014	Class II	Titan 3T MRI System, MRT-3010A/5. Product Usage: Usage: MRI system.	Canon Medical Systems USA, Inc.	LNH	2013-10-28
Z-0342-2014	Class II	TruSystem Surgical Table (TS7000) Leg Section One Part Light HU Use of the Leg Section...	Hill-Rom Inc.	JEB	2013-10-28
Z-1126-2014	Class II	*** 1) List number 126970465 labeled in part: 12697-65 LifeShield LATEX-FREE HEMA; Y-TYPE...	Abbott Medical	FPA	2013-10-25
Z-0557-2014	Class II	VITROS Anti-HBs Calibrators & VITROS Anti-HBs Reagent Packs	Ortho-Clinical Diagnostics, Inc.	LOM	2013-10-25
Z-0381-2014	Class II	REF 200068 Security (TM) Enclosed Carpal Tunnel System Blade ( Single) ABS /Stainless...	Zimmer GmbH	FZX	2013-10-25
Z-0467-2014	Class II	1) Accolade II 127 Neck Angle Hip Stem, Size # 3 2) Accolade II 127 Neck Angle Hip Stem...	Howmedica Osteonics Corp	JDI	2013-10-25
Z-0367-2014	Class II	GE Healthcare Discovery NMCT 670, Discovery NM 630, Optima NMCT 640, & Brivo NM 615. The...	GE Healthcare	KPS	2013-10-25
Z-0385-2014	Class II	ACCU-CHEK Aviva Combo Blood Glucose Meter (as a part of the ACCU-CHEK Aviva Combo...	Roche Diagnostics GmbH	NBW	2013-10-25
Z-0803-2014	Class II	Civco Belly Board MRI, Reusable non-sterile glass fiber belly board with cushion, REF...	CIVCO Medical Instruments Co., Inc.	IYE	2013-10-25
Z-0802-2014	Class II	Civco Belly Board, Reusable non-sterile carbon fiber belly board with cushion, REF...	CIVCO Medical Instruments Co., Inc.	IYE	2013-10-25
Z-0518-2014	Class II	Kimberly-Clark Single Shot Epidural Pain Management Trays containing the BD LOR Syringe...	Kimberly-Clark Corporation	CAZ	2013-10-24
Z-0439-2014	Class II	C-Series: Clinac, Trilogy, Trilogy Tx. , Novalis high energy linear accelerators and...	Varian Medical Systems, Inc.	IYE	2013-10-24
Z-0273-2014	Class II	Osseocare Pro Console & Set Osseocare Pro, Model 1600870-001, 1700470-001, and...	Nobel Biocare USA LLC	EBW	2013-10-24
Z-0362-2014	Class II	Fixed Offset Adapter, A-642100. The Offset Adapter is a fixed modular component which...	Ossur Americas	ISH	2013-10-24
Z-0203-2015	Class II	BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT)...	Philips North America LLC	KPS	2013-10-23
Z-0438-2014	Class II	SIEMENS brand ARTISTE Linear Accelerator Linac systems with component: any photon unflat...	Siemens Medical Solutions USA, Inc.	IYE	2013-10-23
Z-0437-2014	Class II	SIEMENS brand ONCOR series Linear Accelerator Linac systems with component: any photon...	Siemens Medical Solutions USA, Inc.	IYE	2013-10-23
Z-0336-2014	Class II	Vascutek Gelsoft Vascular Graft (peripheral) Labeling reads in part, "***Gelsoft Gelatin...	Terumo Cardiovascular Systems Corporation	DSY	2013-10-23
Z-0379-2014	Class III	Product Brand Name(s): Alere Cholestech LDX Lipid Profile"GLU Test Cassette, Model...	Alere San Diego, Inc.	CGA	2013-10-23
Z-0334-2014	Class II	Zeiss brand IOLMaster 500, Model 500, Biomicroscope, Slit-Lamp, AC-Powered, Product is...	Carl Zeiss Meditec Inc	HJO	2013-10-23
Z-0333-2014	Class II	Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered, Product is...	Carl Zeiss Meditec Inc	HJO	2013-10-23
Z-0196-2014	Class II	Sarns" Venous Return Cannulae, 20 Fr with 1/4" flare, 14.5" (37 cm) long. Indicated for...	Terumo Cardiovascular Systems Corporation	DWF	2013-10-23
Z-0195-2014	Class II	Sarns" Soft-Flow Aortic Cannula without Suture Flange, straight tip, wire-reinforced...	Terumo Cardiovascular Systems Corporation	DWF	2013-10-23
Z-0194-2014	Class II	Sarns" Soft-Flow Aortic Cannula without Suture Flange, straight tip, wire-reinforced...	Terumo Cardiovascular Systems Corporation	DWF	2013-10-23
Z-0193-2014	Class II	Sarns" Soft-Flow Aortic Cannula without Suture Flange, angled tip, wire-reinforced with...	Terumo Cardiovascular Systems Corporation	DWF	2013-10-23
Z-0281-2014	Class II	Ray Station Radiation Therapy Treatment Planning System, Model Numbers 3.0, 3.5 and 4.0	RaySearch Laboratories AB (publ)	MUJ	2013-10-23
Z-0332-2014	Class II	ALTRUS THERMAL TISSUE FUSION, Tissue Fusion Handpiece, 5 mm O.D., 36 cm Shaft, REF...	ConMed Corporation	GEI	2013-10-23
Z-0331-2014	Class II	ALTRUS THERMAL TISSUE FUSION, Tissue Fusion Handpiece, 5 mm O.D., 16 cm Shaft, REF...	ConMed Corporation	GEI	2013-10-23
Z-0363-2014	Class II	Model FL14E Rose BedsThe Rose Bed is an AC-powered adjustable long-term care bed...	Stryker Medical	FNL	2013-10-23
Z-0169-2014	Class II	VitreaCore software. Versions subject to the limitation: 6.0, 6.1, 6.2, 6.3 (except 6.3.1...	Canon Medical Informatics, Inc.	LLZ	2013-10-21
Z-0183-2014	Class II	Applied Medical's Inzii 12/15mm Retrieval System. Applieds Inzii Tissue Retrieval Bag...	Applied Medical Resources Corp	GCJ	2013-10-21
Z-0182-2014	Class II	Prostiva RF Therapy Hand Piece Kit, REF 8929, Rx only, sterilized using Ethylene...	Urologix, LLC	GEI	2013-10-21
Z-0146-2014	Class III	da Vinci Vision System Cart, a component of the da Vinci Si Surgical System IS3000; Y1903...	Intuitive Surgical, Inc.	NAY	2013-10-21
Z-0268-2014	Class I	ZINGER Steerable Guidewire; Models: LVZRLS180J, LVZRLS180S, LVZRMS180J, LVZRMS180S...	Medtronic, Inc.	DQT	2013-10-21
Z-0267-2014	Class I	THUNDER Steerable Guidewire; Model: LVTNDR190S Medtronic guide wires are steerable...	Medtronic, Inc.	LIT	2013-10-21
Z-0266-2014	Class I	COUGAR Steerable Guidewire; Models: LVCLS190J, LVCLS190S, LVCXT190J, LVCXT190S Medtronic...	Medtronic, Inc.	DQX	2013-10-21
Z-0265-2014	Class I	ATTAIN HYBRID Guide Wire; Models: GWR419478, GWR419488, GWR419688 The Attain Hybrid...	Medtronic, Inc.	DQX	2013-10-21
Z-0264-2014	Class I	ProVia CROSSING GUIDEWIRE; Models: 15PROV300HS, 3PROV180HS, 3PROV180SS, 3PROV300HS...	Medtronic, Inc.	DQX	2013-10-21
Z-0263-2014	Class I	THUNDER Extra Support Guidewire; Models: THNDR190J, THNDR190S, THNDR300J...	Medtronic, Inc.	LIT	2013-10-21
Z-0262-2014	Class I	Zinger Stainless Steel Workhorse Guidewire; Models: ZNGRLS180HJ, ZNGRLS180HS...	Medtronic, Inc.	DQT	2013-10-21
Z-0261-2014	Class I	Cougar Nitinol Workhorse Guidewire: Models: CGRLS190HJ, CGRLS190HS, CGRLS190S...	Medtronic, Inc.	DQX	2013-10-21
Z-0478-2014	Class II	AMSCO Evolution steam sterilizer Transfer Carriage. Product Usage: Mobile, wheeled...	STERIS Corporation	FLE	2013-10-18
Z-0340-2014	Class II	Reprocessed Diagnostic Electrophysiology (EP) Catheters and Diagnostic EP Catheter...	Stryker Sustainability Solutions	NLH	2013-10-18
Z-0544-2014	Class II	PedFuse Reset Screw; Model: 01-80115-55 The PedFuse Reset pedicle screw implants...	SPINEFRONTIER, Inc. dba LESspine Innovations	MNI	2013-10-18
Z-0190-2014	Class II	Sterrad 100NX, Product Code: 10104. Used to sterilize heat and moisture sensitive...	Advanced Sterilization Products	MLR	2013-10-18
Z-0099-2015	Class II	CRN Crono Syringe CRN20 with 19G x 1 "Steel Needle"	Intra Pump Infusion Systems	FRN	2013-10-18
Z-0080-2015	Class II	15 L Cycler Drainage Bag Product Usage: For use with Baxter Cycler Tubing sets as a...	Baxter Healthcare Corporation	KDJ	2013-10-17