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 665 of 1191

FDA device recalls, page 665 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-1177-2015	Class II	NAMIC Convenience Kit, UPN H7496016046121, REF/Catalog No. 601604612, STERILE, Rx ONLY...	Boston Scientific Corporation	OEZ	2015-01-09
Z-1176-2015	Class II	NAMIC Convenience Kit, RADIOLOGY KIT, UPN H749601506921, REF/Catalog No. 60150692...	Boston Scientific Corporation	OEQ	2015-01-09
Z-1175-2015	Class II	NAMIC Convenience Kit, LEFT HEART KIT, UPN H749601506721, REF/Catalog No. 60150672...	Boston Scientific Corporation	OEZ	2015-01-09
Z-1174-2015	Class II	NAMIC Convenience Kit, UPN H749601399921, REF/Catalog No. 60139992, STERILE, Rx ONLY...	Boston Scientific Corporation	OEZ	2015-01-09
Z-1173-2015	Class II	NAMIC Convenience Kit, DYE CATH LAB KIT, UPN H749601367131, REF/Catalog No. 60136713...	Boston Scientific Corporation	OEQ	2015-01-09
Z-1172-2015	Class II	NAMIC Convenience Kit, ANGIO KIT, UPN H749601319961, REF/Catalog No. 60131996, STERILE...	Boston Scientific Corporation	OEQ	2015-01-09
Z-1171-2015	Class II	NAMIC Convenience Kit, UPN H7496013148131, REF/Catalog No. 601314813, STERILE, Rx ONLY...	Boston Scientific Corporation	OEZ	2015-01-09
Z-1170-2015	Class II	NAMIC Convenience Kit, UPN H749601314811, REF/Catalog No. 60131481, STERILE, Rx ONLY...	Boston Scientific Corporation	OEZ	2015-01-09
Z-1169-2015	Class II	NAMIC Convenience Kit, UPN H749601308341, REF/Catalog No. 60130834, STERILE, Rx ONLY...	Boston Scientific Corporation	OEZ	2015-01-09
Z-1168-2015	Class II	NAMIC Convenience Kit, LEFT HEART KIT, UPN H749601113111, REF/Catalog No. 60111311...	Boston Scientific Corporation	OEZ	2015-01-09
Z-1167-2015	Class II	NAMIC Convenience Kit, RADIOLOGY KIT, UPN H749601014911, REF/Catalog No. 60101491...	Boston Scientific Corporation	OEQ	2015-01-09
Z-1166-2015	Class II	NAMIC Convenience Kit, LEFT HEART CATH KIT, UPN H7496010018151, REF/Catalog No...	Boston Scientific Corporation	OEZ	2015-01-09
Z-1165-2015	Class II	NAMIC Convenience Kit, LEFT/RIGHT HEART KIT, UPN H7496008010201, REF/Catalog No...	Boston Scientific Corporation	OEZ	2015-01-09
Z-1164-2015	Class II	NAMIC Convenience Kit, 3 VALVE KIT, UPN H749600709971, REF/Catalog No. 60070997, STERILE...	Boston Scientific Corporation	OEZ	2015-01-09
Z-1163-2015	Class II	NAMIC Convenience Kit, LEFT HEART KIT, UPN H7496007057101, REF/Catalog No. 600705710...	Boston Scientific Corporation	OEZ	2015-01-09
Z-1162-2015	Class II	NAMIC Convenience Kit, LEFT HEART KIT, UPN H749600618011, REF/Catalog No. 60061801...	Boston Scientific Corporation	OEZ	2015-01-09
Z-1161-2015	Class II	NAMIC Convenience Kit, RADIOLOGY KIT, UPN H749600617521, REF/Catalog No. 60061752...	Boston Scientific Corporation	OEQ	2015-01-09
Z-1160-2015	Class II	NAMIC Convenience Kit, LEFT HEART, UPN H7496006044121, REF/Catalog No. 600604412...	Boston Scientific Corporation	OEZ	2015-01-09
Z-1159-2015	Class II	NAMIC Convenience Kit, UPN H7496005216131, REF/Catalog No. 600521613, STERILE, Rx ONLY...	Boston Scientific Corporation	OEZ	2015-01-09
Z-1158-2015	Class II	NAMIC Convenience Kit, LEFT HEART KIT, UPN H7496005001131, REF/Catalog No. 600500113...	Boston Scientific Corporation	OEZ	2015-01-09
Z-1157-2015	Class II	NAMIC Convenience Kit, MOBILE CATH LAB KIT, UPN H749600419211, REF/Catalog No. 60041921...	Boston Scientific Corporation	OEZ	2015-01-09
Z-1156-2015	Class II	NAMIC Convenience Kit, 3 VALVE MANIFOLD KIT, UPN H749600411611, REF/Catalog No. 60041161...	Boston Scientific Corporation	OEZ	2015-01-09
Z-1155-2015	Class II	NAMIC Convenience Kit, LEFT HEART KIT, UPN H749600407061, REF/Catalog No. 60040706...	Boston Scientific Corporation	OEZ	2015-01-09
Z-1154-2015	Class II	NAMIC Convenience Kit, 3 VALVE KIT CARDIOVASCULAR PROCEDURE KIT, UPN H749600403131...	Boston Scientific Corporation	OEZ	2015-01-09
Z-1153-2015	Class II	NAMIC Convenience Kit, UPN H749600329421, REF/Catalog No. 60032942, STERILE, Rx ONLY...	Boston Scientific Corporation	OEZ	2015-01-09
Z-1152-2015	Class II	NAMIC Convenience Kit, LEFT HEART KIT, UPN H749600309351, REF/Catalog No. 60030935...	Boston Scientific Corporation	OEZ	2015-01-09
Z-1151-2015	Class II	NAMIC Convenience Kit, UPN H749600203741, REF/Catalog No. 60020374, STERILE, Rx ONLY...	Boston Scientific Corporation	OEZ	2015-01-09
Z-1150-2015	Class II	NAMIC Convenience Kit, NEURO ANGIO KIT, UPN H749600202361, REF/Catalog No. 60020236...	Boston Scientific Corporation	OEZ	2015-01-09
Z-1149-2015	Class II	NAMIC Convenience Kit, 5 VALVE MANIFOLD KIT, UPN H749600105121, REF/Catalog No. 60010512...	Boston Scientific Corporation	OEZ	2015-01-09
Z-1148-2015	Class II	NAMIC Convenience Kit, LEFT HEART KIT, UPN H7496001001111, REF/Catalog No. 600100111...	Boston Scientific Corporation	OEZ	2015-01-09
Z-1125-2015	Class III	Alive ECG App 2.1.2 ( a medical device application for the Apple iOS operating system...	AliveCor	DXH	2015-01-09
Z-1030-2015	Class III	Arrow Select Kits (ASK), Maximal Barrier Precautions Kits (CDC) and Arterial...	Arrow International LLC (subsidiary of Teleflex Incorporated)	OBJ	2015-01-09
Z-1147-2015	Class II	The Medtronic, Quadripolar ITREL 3 IPG, Model 7425, is a multiprogrammable device...	Medtronic Neuromodulation	LGW	2015-01-09
Z-1078-2015	Class II	Hudson RCI, Sheridan, Preformed Tracheal Tubes, Cuffed and Uncuffed, Rx Only, Sterile...	Teleflex Medical	BTR	2015-01-09
Z-1061-2015	Class I	Echostar Spica 1.5T MRI system, for magnetic resonance imaging of the body.	Alltech Medical Systems America, Inc.	LNH	2015-01-09
Z-1178-2016	Class II	Pilling Modular Verres Body/Obturator, Product Code 140880	Teleflex Medical	GDM	2015-01-08
Z-1378-2015	Class II	CS 8100 3D, CATALOG # (s): 5311162, 5311188. Intended to produce complete or segmented...	Eastman Kodak Company	MUH	2015-01-08
Z-1377-2015	Class II	CS 8100, CATALOG # (s): 5303045, 5311129, 5303060, 5303110 Intended to produce complete...	Eastman Kodak Company	MUH	2015-01-08
Z-1066-2015	Class II	System 6 Aseptic Housing. The Stryker System 6 Aseptic Housings provide a sterile...	Stryker Corp.	HWE	2015-01-07
Z-1208-2015	Class II	Comprehensive Reverse Shoulder Glenosphere Mini Baseplate 25mm with Taper Adaptor, Part...	Zimmer GmbH	KWS	2015-01-07
Z-1088-2015	Class II	Precise Digital Accelerator Intended to be used for radiation therapy treatments of...	Elekta Limited	IYE	2015-01-07
Z-1035-2015	Class I	This correction applies to all GE Healthcare MRI systems with superconducting magnets...	GE Healthcare	LNH	2015-01-07
Z-1129-2015	Class II	Cold Therapy Pad - cold water circulating pad, one unit per package. The pads are used...	Gentherm Medical, LLC	ILO	2015-01-07
Z-1232-2017	Class II	Titan" Stabilizer Attachment and Titan TM 360 Stabilizer Attachment	Terumo Cardiovascular Systems Corporation	MWS	2015-01-05
Z-0123-2016	Class II	The Ebb Complete Tamponade System, model #CTS-1000 and Code #OQY. Intended for use in...	Clinical Innovations, LLC	OQY	2015-01-05
Z-1080-2015	Class II	ARROW Epidural Needle Component (product number AN-05501). Epidural needles permit...	Arrow International LLC (subsidiary of Teleflex Incorporated)	CAZ	2015-01-05
Z-1013-2015	Class II	Syngo RT Therapist: The intended use of the SIEMENS branded ARTISTE, ONCOR and PRIMUS...	Siemens Medical Solutions USA, Inc.	IYE	2015-01-02
Z-1082-2015	Class II	ARROWg+ard Blue PLUS Pressure Injectable Two-Lumen CVC Kit. The Multiple-Lumen Catheter...	Arrow International LLC (subsidiary of Teleflex Incorporated)	FOZ	2015-01-02
Z-1068-2015	Class II	EPWorks software used in the Xltek Protektor Stimulator Product Usage: Intraoperative...	Natus Medical Incorporated	GWF	2015-01-02
Z-1067-2015	Class II	EPWorks software used in the Protektor 32 Product Usage: Uses electroencephalography...	Natus Medical Incorporated	GWE	2015-01-02