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 610 of 1191

FDA device recalls, page 610 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-0930-2016	Class II	EndoVive 3s Low Profile Balloon Kits Part Number: M00548840 (XMD P/N 70-0050-320) The...	Xeridiem Medical Devices	PIF	2015-12-23
Z-0929-2016	Class II	EndoVive 3s Low Profile Balloon Kits Part Number: M00548680 (XMD P/N 70-0050-318) The...	Xeridiem Medical Devices	PIF	2015-12-23
Z-0928-2016	Class II	EndoVive 3s Low Profile Balloon Kits Part Number: M00548520 (XMD P/N 70-0050-316) The...	Xeridiem Medical Devices	PIF	2015-12-23
Z-0927-2016	Class II	EndoVive 3s Low Profile Balloon Kits Part Number: M00548360 (XMD P/N 70-0050-314) The...	Xeridiem Medical Devices	PIF	2015-12-23
Z-0926-2016	Class II	EndoVive 3s Low Profile Balloon Kits Part Number: M00548240 (XMD P/N 70-0050-312) The...	Xeridiem Medical Devices	PIF	2015-12-23
Z-0925-2016	Class II	EndoVive 3s Low Profile Balloon Kits Part Number: M00549320 (XMD P/N 70-0050-222) The...	Xeridiem Medical Devices	PIF	2015-12-23
Z-0924-2016	Class II	EndoVive 3s Low Profile Balloon Kits Part Number: M00548830 (XMD P/N 70-0050-220) The...	Xeridiem Medical Devices	PIF	2015-12-23
Z-0923-2016	Class II	EndoVive 3s Low Profile Balloon Kits Part Number: M00548670 (XMD P/N 70-0050-218) The...	Xeridiem Medical Devices	PIF	2015-12-23
Z-0922-2016	Class II	EndoVive 3s Low Profile Balloon Kits Part Number: M00548510 (XMD P/N 70-0050-216) The...	Xeridiem Medical Devices	PIF	2015-12-23
Z-0921-2016	Class II	EndoVive 3s Low Profile Balloon Kits Part Number: M00548350 (XMD P/N 70-0050-214) The...	Xeridiem Medical Devices	PIF	2015-12-23
Z-0920-2016	Class II	EndoVive 3s Low Profile Balloon Kits Part Number: M00548230 (XMD P/N 70-0050-212) The...	Xeridiem Medical Devices	PIF	2015-12-23
Z-0919-2016	Class II	EndoVive 3s Low Profile Balloon Kits Part Number: M00549310 (XMD P/N 70-0050-122) The...	Xeridiem Medical Devices	PIF	2015-12-23
Z-0918-2016	Class II	EndoVive 3s Low Profile Balloon Kits Part Number: M00548820 (XMD P/N 70-0050-120) The...	Xeridiem Medical Devices	PIF	2015-12-23
Z-0917-2016	Class II	EndoVive 3s Low Profile Balloon Kits Part Number: M00548660 (XMD P/N 70-0050-118) The...	Xeridiem Medical Devices	PIF	2015-12-23
Z-0916-2016	Class II	EndoVive 3s Low Profile Balloon Kits Part Number: M00548500 (XMD P/N 70-0050-116) The...	Xeridiem Medical Devices	PIF	2015-12-23
Z-0915-2016	Class II	EndoVive 3s Low Profile Balloon Kits Part Number: M00548340 (XMD P/N 70-0050-114) The...	Xeridiem Medical Devices	PIF	2015-12-23
Z-0914-2016	Class II	EndoVive 3s Low Profile Balloon Kits Part Number: M00548220 (XMD P/N 70-0050-112) The...	Xeridiem Medical Devices	PIF	2015-12-23
Z-0913-2016	Class II	EndoVive 3s Low Profile Balloon Kits Part Number: M00548330 (XMD P/N 70-0050-014) The...	Xeridiem Medical Devices	PIF	2015-12-23
Z-0912-2016	Class II	EndoVive 3s Low Profile Balloon Kits Part Number: M00548460 (XMD P/N 70-0050-D14) The...	Xeridiem Medical Devices	PIF	2015-12-23
Z-0768-2016	Class II	GE Healthcare, Optima XR220amx, Mobile Digital Ready Radiographic System Designed to...	GE Healthcare	IZL	2015-12-23
Z-0688-2016	Class II	Moog Curlin Infusion, Ambulatory Infusion Pump The Curlin Ambulatory Infusion System...	Zevex, Inc.	FRN	2015-12-23
Z-1332-2016	Class II	STD KIT GK260, Standard Set 360 Z Product Usage: The Epix disposable laparoscopic clip...	Applied Medical Resources Corp	MCH	2015-12-22
Z-1331-2016	Class II	STD KIT GK213, AME Standard Kit 15 Product Usage: The Epix disposable laparoscopic clip...	Applied Medical Resources Corp	MCH	2015-12-22
Z-1330-2016	Class II	STD GK258, AME Standard Kit 44 Product Usage: The Epix disposable laparoscopic clip...	Applied Medical Resources Corp	MCH	2015-12-22
Z-1329-2016	Class II	CA500 Epix Universal Clip Applier Product Usage: The Epix disposable laparoscopic clip...	Applied Medical Resources Corp	MCH	2015-12-22
Z-0863-2016	Class II	The Symbiq infusion pump is a device used in a health care facility to pump fluids into a...	Abbott Medical	FRN	2015-12-22
Z-0862-2016	Class II	Syngo Plaza Picture archiving and communication system. Software only. PACS intended to...	Siemens Medical Solutions USA, Inc.	LLZ	2015-12-22
Z-0807-2016	Class II	EVOLIS Microplate System, Catalog # 89601. Part number 89788 for the EVOLIS Operator's...	Bio-Rad Laboratories Inc.	JJE	2015-12-22
Z-0692-2016	Class I	Emergency Transport Ventilator Oxylog 3000 Ventilator and Oxylog 3000 plus...	Draeger, Inc.	CBK	2015-12-22
Z-0689-2016	Class II	Zilver 518RX Vascular Stent with Rapid Exchange Delivery System	Cook Medical LLC	NIO	2015-12-22
Z-0691-2016	Class I	Emergency Transport Ventilator Oxylog 2000 Plus Ventilator Catalog Number...	Draeger, Inc.	CBK	2015-12-22
Z-0583-2016	Class II	InterGuard 5.5mm Econo Refill, sizes, 4.0mm for short anatomical crowns and 5.5mm, part #...	Ultradent Products Inc.	DZN	2015-12-22
Z-1314-2016	Class II	NEL- GBS Medium (Broth 3 ml Fill 13 x 100 mm Screw Cap Tube Catalog No.: T8000; For the...	Analytichem USA, Inc.	JSI	2015-12-21
Z-1313-2016	Class II	NEL GBS Medium 20 ml in 100x15mm plate (Standard Petri Dish) Catalog No.: P8000; For the...	Analytichem USA, Inc.	JSI	2015-12-21
Z-1842-2016	Class II	Hip Preservation System Signature Series PreBent Burs under the following labels: 1)...	ConMed Corporation	GFF	2015-12-21
Z-1075-2016	Class II	VITROS 5,1 FS Chemistry System, Catalog Number 6801375, Unique Device Identifier Number...	Ortho-Clinical Diagnostics, Inc.	JJE	2015-12-21
Z-1074-2016	Class II	VITROS 5600 Chemistry System, Catalog Number 6802413, Unique Device Identifier Number...	Ortho-Clinical Diagnostics, Inc.	JJE	2015-12-21
Z-1073-2016	Class II	VITROS 4600 Chemistry System, Catalog Number 6802445, Unique Device Identifier Number...	Ortho-Clinical Diagnostics, Inc.	JJE	2015-12-21
Z-1072-2016	Class II	VITROS 350 Chemistry System, Catalog Number 6802153, Unique Device Identifier Number...	Ortho-Clinical Diagnostics, Inc.	JJE	2015-12-21
Z-1388-2016	Class II	The Concerto Basic Shower Trolley is intended for assisted hygiene care, especially...	Arjo, Inc.	FSA	2015-12-21
Z-1322-2016	Class II	The THERAKOS CELLEX Photopheresis System is a photoimmune therapy. Catalog...	Therakos Inc	LNR	2015-12-21
Z-1071-2016	Class II	VITROS 250 Chemistry Systems, Catalog 8132086, Unique Device Identifier No...	Ortho-Clinical Diagnostics, Inc.	JJE	2015-12-21
Z-0661-2016	Class II	Fukuda Denshi patient monitor model DS-8100M and DS-8100N. The Fukuda Denshi DynaScope...	Fukuda Denshi USA, Inc.	MHX	2015-12-21
Z-0731-2016	Class II	Baxter, RAPIDFILL Syringe Strip, 10 ml. For use with RAPIDFILL Automated Syringe Filler...	Baxter Corporation Englewood	FMF	2015-12-21
Z-0744-2016	Class II	ACIST Medical Systems, BT2000 Automated Manifold Kit (SKU 014613) and CPT2000 (SKU...	Acist Medical Systems, Inc.	DXT	2015-12-21
Z-0828-2016	Class II	Stryker Aero-AL Impaction handle Catalog Number 48921007. Stryker Spine Manufactured by...	Howmedica Osteonics Corp	LXH	2015-12-18
Z-0694-2016	Class II	Fuse 1C Colonoscope	Boston Scientific Corporation	FDF	2015-12-18
Z-1027-2016	Class II	NeoCoil 3.0T GEM Flex Coil. The 3.0T GEM Flex coil system includes three sizes of coil...	NeoCoil, LLC	MOS	2015-12-18
Z-0736-2016	Class II	HemosIL Plasminogen, Part No. 0020009000, IVD. Instrumentation Laboratory Company. Kit...	Instrumentation Laboratory Co.	GGP	2015-12-18
Z-0763-2016	Class II	Mavig Monitor Suspension System, Model GD60, contained in the following Fluoroscopic...	GE Healthcare	OWB	2015-12-18