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 731 of 1191

FDA device recalls, page 731 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-1021-2014	Class II	I/B II KNEE DOMED PATELLA, I/B II KNEE FLUTED ROD (1 and 2), MGII KNEE 10MM PATELLA (2,3...	Zimmer GmbH	JWH	2013-10-11
Z-1020-2014	Class II	NEXGEN OSTEOTOMY CORT BON. Item codes starting with 0052500	Zimmer GmbH	HWC	2013-10-11
Z-1019-2014	Class II	Bipolar liners and Multipolar cups with the following dimensions in MM (38, 39, 40, 41...	Zimmer GmbH	KWY	2013-10-11
Z-1018-2014	Class II	MODULAR AUSTIN MOORE FENE. Item codes starting with 45502001, 455503001 and 455504001	Zimmer GmbH	KMC	2013-10-11
Z-1017-2014	Class II	MOORE HIP PROS LONG FENES, MOORE HIP PROS NRW STR FE, MOORE HIP PROS STR FENEST, THOMPSON...	Zimmer GmbH	JDG	2013-10-11
Z-1016-2014	Class II	MOORE HIP PROS LONG FENES, MOORE HIP PROS NRW STR FE, MOORE HIP PROS STR FENEST, THOMPSON...	Zimmer GmbH	JDG	2013-10-11
Z-1015-2014	Class II	DISTAL MEDIAL FEMORAL CON, DISTAL POSTERIOR/LATERAL, DISTAL SMALL VOLAR RADIUS, PROXIMAL...	Zimmer GmbH	NDF	2013-10-11
Z-1014-2014	Class II	ONE-PIECE LAG SCREW 11MM. Item codes starting with 00225900.	Zimmer GmbH	HSB	2013-10-11
Z-1013-2014	Class II	ITST ANTI-ROTATION SCREW and FEM IM NAIL (10MM, 11 MM, 12 MM, 13 MM, 14 MM and 15 MM)...	Zimmer GmbH	HSB	2013-10-11
Z-1012-2014	Class II	Asia One-Piece Lag Screw	Zimmer GmbH	HSB	2013-10-11
Z-1011-2014	Class II	M/DN HUMERAL I/M NAIL. Sizes from 6 MM to 13 MM. Codes starting with 0022541, 002542 and...	Zimmer GmbH	HSB	2013-10-11
Z-1010-2014	Class II	INTERLOCKING IM SCREW 4.5 and INTERLOCKING IM SCREW LG Some items starting with codes...	Zimmer GmbH	NDJ	2013-10-11
Z-1009-2014	Class II	INTERLOCKING IM SCREW SML, MED and LRG; M/DN TIBIAL I/M NAIL 6 MM to 15 MM. Some items...	Zimmer GmbH	HSB	2013-10-11
Z-1008-2014	Class II	RECON SCREW LG 5.5MM DIA and M/DN FEM IM NAIL 8MM DIA to 16 MM DIA. Item codes starting...	Zimmer GmbH	HSB	2013-10-11
Z-1007-2014	Class II	M/DN R-F IM NAIL 9MM DIA , 10 MM, 11 MM, 12 MM, 13 MM and 14 MM. Item codes starting with...	Zimmer GmbH	HSB	2013-10-11
Z-1006-2014	Class II	VERSA-FX KEYLESS 90D X 8 and X 11, VERSA-FX KEYLESS 95D X 8, X 11, and X 14, VERSA-FX...	Zimmer GmbH	KTT	2013-10-11
Z-1005-2014	Class II	VERSA-FX II KEYLESS TUBE, VERSA-FX II KEYLESS SHORT, VERSA-FX II SHORT TUBE PL, VERSA-FX...	Zimmer GmbH	KTT	2013-10-11
Z-1004-2014	Class II	Item codes starting with 001930 LAG SCR 12.7D X 55MM SHOR up to 155 MM, LAG SCR 12.7D X...	Zimmer GmbH	JDO	2013-10-11
Z-1003-2014	Class II	FREE-LOCK LAG SCREW, 12.7, FREE-LOCK LAG SCREW, 15.8, FREE-LOCK SUPRACOND TUBE and...	Zimmer GmbH	KTT	2013-10-11
Z-1002-2014	Class II	HERBERT MINI BONE SCREW 2 and HERBERT/WHIPPLE C ANN BONE. Items starting with 0011500 and...	Zimmer GmbH	HWC	2013-10-11
Z-0789-2014	Class I	TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System: One 1 g tube of n-BCA, one...	Cerenovus, Inc.	KGG	2013-10-11
Z-0489-2014	Class II	HGE Healthcare Patient Monitor B30, Procare Monitor B20, Procare Monitor B40, and Monitor...	GE Healthcare	MHX	2013-10-11
Z-0790-2014	Class II	BD GeneOhm Cdiff Assay, Part #441401, containing Lysis Kit sample buffer tubes, 200...	Becton Dickinson & Co	LLH	2013-10-11
Z-0335-2014	Class II	Brilliance iCT Computed Tomography X-Ray System, Product Usage: The Brilliance iCT is...	Philips North America LLC	JAK	2013-10-11
Z-0174-2014	Class II	US Safire Duo Ablation Catheter MediGuide Enabled, REF A700240 and Cool Path Duo Ablation...	Abbott Medical	OAD	2013-10-11
Z-0187-2014	Class II	Safire Duo Ablation Catheter MediGuide Enabled, REF A700240 and A700238, Rx only, Sterile...	Abbott Medical	OAD	2013-10-11
Z-1001-2014	Class II	Magna-Fx Cannulated Screw Fixation System 7.0 mm. Item codes starting with 0011420, 11460...	Zimmer GmbH	HWC	2013-10-11
Z-0788-2014	Class I	TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System; Two 1 g tubes of n-BCA, one...	Cerenovus, Inc.	KGG	2013-10-11
Z-0373-2014	Class II	GE Vivid E9 ultrasound system. GE Vivid E9 is a Track 3 diagnostic ultrasound system...	GE Healthcare	IYO	2013-10-11
Z-2571-2018	Class II	Drill (Fluted-Hard Bone), for Quattro Link 2.9mm, labeled as: a. Quattro Spade Drill...	Cayenne Medical Inc.	HTW	2013-10-10
Z-1507-2016	Class II	VariAx Compression Plating System	Howmedica Osteonics Corp	HWC	2013-10-10
Z-2685-2014	Class II	The Verigene Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test...	Luminex Corporation	PCH	2013-10-10
Z-2684-2014	Class II	The Verigene Respiratory Virus Plus Nucleic Acid Test (RV+) on the Verigene System is a...	Luminex Corporation	OCC	2013-10-10
Z-2683-2014	Class II	The Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-UP) performed using the...	Luminex Corporation	PAM	2013-10-10
Z-2682-2014	Class II	The Verigene Clostridium difficile Nucleic Acid Test (CDF) is a qualitative, multiplexed...	Luminex Corporation	OZN	2013-10-10
Z-2681-2014	Class II	The Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN), performed using the...	Luminex Corporation	PEN	2013-10-10
Z-0364-2014	Class II	Juggerknotless Drill Bit, REF 110003173, Sterile, Single Use Product Usage: The...	Zimmer GmbH	MBI	2013-10-10
Z-0378-2014	Class II	Mizuho Sugita Titanium Standard Aneurysm Clip II , Temporary Mini Type No 58 Temporary...	Mizuho America, Inc.	HCH	2013-10-10
Z-0377-2014	Class II	Mizuho Sugita Titanium Standard Aneurysm Clip II , Temporary and permanent occlusion of...	Mizuho America, Inc.	HCH	2013-10-10
Z-0968-2014	Class II	VITROS Chemistry Products Mixing Cup Arrays utilized on VITROS 250 & 350 Chemistry...	Ortho-Clinical Diagnostics, Inc.	JRB	2013-10-10
Z-0650-2014	Class II	Nova StatStrip/StatSensor Hospital Blood Glucose Meter; Nova StatStrip Lactate Hospital...	Nova Biomedical Corporation	CGA	2013-10-10
Z-1361-2016	Class II	Neurotherm NT2000iX RF Generator Model Number: RFG-NT -2000iX	Neurotherm, Inc.	GXD	2013-10-09
Z-0840-2014	Class II	GE Optima CT520 and Optima CT540 Computed Tomography (CT) systems. Intended to produce...	GE Healthcare	JAK	2013-10-09
Z-0546-2014	Class II	Continuous Peripheral Nerve Block Catheter Kit and Set Continuous Peripheral Nerve Block...	Arrow International LLC (subsidiary of Teleflex Incorporated)	CAZ	2013-10-09
Z-0468-2014	Class II	Arrow Transradial Artery Access products Arrow Transradial Artery Access products are...	Arrow International LLC (subsidiary of Teleflex Incorporated)	DYB	2013-10-09
Z-0473-2014	Class II	Synthes TomoFix Plates The Synthes J5606-C TomoFix Osteotomy System is used for open and...	Synthes GmbH	KTT	2013-10-09
Z-0525-2014	Class II	VITROS CA 125 II Calibrators For use in the calibration of the VITROS ECi/ECiQ...	Ortho-Clinical Diagnostics, Inc.	LTK	2013-10-09
Z-0357-2014	Class II	Trinica Anterior Lumbar Plate (ALP) system, part 07.01058.001. Non Sterile, Rx only. The...	Zimmer GmbH	KWQ	2013-10-09
Z-0405-2014	Class II	Synthes Implant Holder for Synfix (TM)-LR the Synthes Implant Holder for Synfix (TM)-LR...	Synthes GmbH	LXH	2013-10-08
Z-0942-2014	Class II	enGen Track System with enGen Custom v3.2.2 (& below) Product The VITROS 5,1 FS...	Ortho-Clinical Diagnostics, Inc.	JJE	2013-10-08