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 635 of 1191

FDA device recalls, page 635 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-2556-2015	Class II	WOUND CLOSURE TRAY I CUSTOMED 50/CS Used by medical staff to perform surgical...	Customed, Inc	MCY	2015-07-10
Z-2555-2015	Class II	MINOR PROCEDURE PACK 40/CS Used by medical staff to perform surgical procedures and...	Customed, Inc	LRO	2015-07-10
Z-2554-2015	Class II	MAJOR LAPAROTOMY PK 4/CS Used by medical staff to perform surgical procedures and...	Customed, Inc	LRO	2015-07-10
Z-2553-2015	Class II	UNIVERSAL DRAINAGE TRAY CUSTOMED 20/CS Used by medical staff to perform surgical...	Customed, Inc	NNZ	2015-07-10
Z-2552-2015	Class II	LAPAROSCOPY PK 3/CS Used by medical staff to perform surgical procedures and...	Customed, Inc	FDE	2015-07-10
Z-2551-2015	Class II	IRRIGATION TRAY W/BULB SYRINGE CUSTOMED 50/CS Used by medical staff to perform patient...	Customed, Inc	KYZ	2015-07-10
Z-2550-2015	Class II	O.B. PK 4/CS Used by medical staff to perform surgical procedures and patient care...	Customed, Inc	OKV	2015-07-10
Z-2549-2015	Class II	SUTURE REMOVAL KIT CUSTOMED 100/CS Used by medical staff to perform patient care...	Customed, Inc	MCZ	2015-07-10
Z-2548-2015	Class II	ANGIODRAPE PK 4/CS Used by medical staff to perform surgical procedures and patient...	Customed, Inc	OEQ	2015-07-10
Z-2463-2015	Class II	HardyCHROM MRSA Cat no: G307 Lot no: H15155 Expires: 2015-08-13 Container Type: 15x100mm...	Hardy Diagnostics	JSO	2015-07-09
Z-2365-2015	Class II	Micro-Mate Tuberculin Glass Syringe, Non-sterile Catalog numbers 5208, 5209	Cadence Inc.	GAA	2015-07-09
Z-2364-2015	Class II	Perfectum Tuberculin Glass Syringe, Non sterile Catalog numbers 5202, 5205, 5212	Cadence Inc.	GAA	2015-07-09
Z-2265-2015	Class II	IPS Empress Universal Glaze Spray 270 mL, Product Code/Model/Catalog Number 609432AN, Rx...	Ivoclar Vivadent, Inc.	EIH	2015-07-09
Z-2433-2015	Class II	Medline Electrical Clipper with Charging base The Electrical Surgical Clipper is...	MEDLINE INDUSTRIES, LP - Northfield	LWK	2015-07-08
Z-2388-2015	Class II	Magic3 Hydrophilic-coated Female Intermittent Urinary Catheter 14 Fr in the Insertion...	C.R. Bard Inc	KOD	2015-07-07
Z-2387-2015	Class II	Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 16 Fr, (30/box)...	C.R. Bard Inc	KOD	2015-07-07
Z-2386-2015	Class II	Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 14 Fr, (30/box)...	C.R. Bard Inc	KOD	2015-07-07
Z-2385-2015	Class II	Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 12 Fr, (30/box)...	C.R. Bard Inc	KOD	2015-07-07
Z-2384-2015	Class II	Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 10 Fr, (30/box)...	C.R. Bard Inc	KOD	2015-07-07
Z-2326-2015	Class II	S4C Occiput Torque Wrench F/Set Screw; used to tighten the S4 Cervical Spinal System...	Aesculap Inc	HXC	2015-07-07
Z-2089-2015	Class II	RadiForce RX850, 8MP Color LCD Monitor, Part Code No. 0FTD1958A2, UPC 690592037180. This...	Eizo Corporation	PGY	2015-07-07
Z-2088-2015	Class II	RadiForce RX650, 6MP Color LCD Monitor, Part Code No. 0FTD1957A5, 0FTD195B5, UPC...	Eizo Corporation	PGY	2015-07-07
Z-2087-2015	Class II	RadiForce GX540, 5MP Monochrome LCD Monitor, Part Code No. 0FTD1826A5, 0FTD1826B5...	Eizo Corporation	PGY	2015-07-07
Z-1024-2016	Class II	SENSE Body Coil 1.5T with identification; used in the ACS NT, Intera 1.5T and Achieva...	Philips North America LLC	LNH	2015-07-06
Z-2719-2015	Class II	Syngo.plaza; picture archiving and communications system Product Usage: Syngo.plaza is a...	Siemens Medical Solutions USA, Inc.	LLZ	2015-07-06
Z-0810-2016	Class II	Actuator for angiographic x-ray monitor ceiling suspension system. Actuator short Assy...	Philips North America LLC	IZI	2015-07-06
Z-2147-2015	Class II	Infant Heel Warmer and Infant Gel Warmer, sold under the brand names CooperSurgical and...	CooperSurgical, Inc.	MPO	2015-07-06
Z-2061-2018	Class II	nordicICE v 2.3.14 nordicICE is an image processing software package to be used by...	NordicNeuroLab AS	LLZ	2015-07-03
Z-1556-2016	Class II	Spirit One A-C Powered Hospital Bed	Stryker Medical	FNL	2015-07-02
Z-2476-2015	Class II	0.9% Sodium Chloride Injection, USP, 10mL in 12mL., Single use, Rx only, Sterile Solution.	Aquabiliti	NGT	2015-07-02
Z-2319-2015	Class I	Slip-Cath Beacon Tip Catheter. Angiographic catheter. For use in angiographic...	Cook Incorporated	DQO	2015-07-02
Z-2318-2015	Class I	Beacon Tip Royal Flush Plus High-Flow Catheter. Angiographic catheter. For use in...	Cook Incorporated	DQO	2015-07-02
Z-2317-2015	Class I	Beacon Tip Torcon NB Advantage Catheter. Angiographic catheter. For use in...	Cook Incorporated	DQO	2015-07-02
Z-1555-2016	Class II	Spirit One A-C Powered Hospital Bed	Stryker Medical	FNL	2015-07-02
Z-2208-2015	Class II	Silhouette Lift brochure Silhouette Sutures are for use in midface suspension surgery to...	Sinclair Pharma US, Inc.	GAM	2015-07-02
Z-2359-2015	Class II	8.5mm Reamer Head for Flexible Intramedullary Nailing System; An orthopedic manual...	Synthes (USA) Products LLC	HTO	2015-07-01
Z-2425-2015	Class II	Synthes Tibial Nail Wrap Holds 11 Nails and Synthes Intramedullary Nail Wrap Holds 10...	Synthes (USA) Products LLC	FSM	2015-07-01
Z-2199-2015	Class II	GEMINI TF Big Bore CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family...	Philips North America LLC	KPS	2015-07-01
Z-2198-2015	Class II	GEMINI TF Base CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of...	Philips North America LLC	KPS	2015-07-01
Z-2197-2015	Class II	GEMINI TF Ready CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of...	Philips North America LLC	KPS	2015-07-01
Z-2196-2015	Class II	GEMINI TF 64 Slice CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family...	Philips North America LLC	KPS	2015-07-01
Z-2195-2015	Class II	GEMINI TF 16 Slice CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family...	Philips North America LLC	KPS	2015-07-01
Z-2194-2015	Class II	GEMINI LXL CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of...	Philips North America LLC	KPS	2015-07-01
Z-2193-2015	Class II	GEMINI GXL 16 Slice CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a...	Philips North America LLC	KPS	2015-07-01
Z-2345-2015	Class II	Synthes Battery Power Line II Oscillator Model 530.710, orthopedic surgical power tool.	The Anspach Effort, Inc.	HTZ	2015-07-01
Z-2201-2015	Class II	iovera 155 Smart Tip; Catalog numbers:STT0412-10 and STT0412-5 (10 and 5 count...	Myoscience, Inc.	GXH	2015-07-01
Z-2063-2015	Class II	MOSAIQ Oncology Information System MOSAIQ is an oncology information system used to...	Elekta Limited	IYE	2015-07-01
Z-2392-2016	Class II	Hitachi Scenaria Computed Tomography System Hitachi Medical Systems America, Twinsburg...	FUJIFILM Healthcare Americas Corporation	JAK	2015-06-30
Z-2404-2015	Class II	Artis zee/ zeego systems; dedicated angiography systems developed for single and biplane...	Siemens Medical Solutions USA, Inc.	OWB	2015-06-30
Z-2416-2015	Class II	ADVIA Chemistry Acetaminophen reagents; for in vitro diagnostic use in the quantitative...	Siemens Healthcare Diagnostics Inc.	LDP	2015-06-30