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 670 of 1191

FDA device recalls, page 670 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-0956-2015	Class II	iPlan RT Dose is a stereotactic radiation treatment planning system that is intended for...	Brainlab, Inc.	MUJ	2014-11-19
Z-0963-2015	Class II	HeartStart MRx Monitor/Defibrillator; Model. Numbers: M3535A, M3536A, M3536J, M3536M...	Philips North America LLC	MKJ	2014-11-19
Z-0933-2015	Class II	CelluTome Epidermal Harvesting System Harvester (5.0 CM) STERILE EO Rx Only Manufactured...	KCI USA, Inc.	GFD	2014-11-19
Z-0917-2015	Class I	Lotus TAVR 27mm, Transcatheter Aortic Valve Prosthesis Premounted on Delivery...	Boston Scientific Corporation	NPT	2014-11-19
Z-0916-2015	Class I	Lotus TAVR 25mm, Transcatheter Aortic Valve Prosthesis Premounted on Delivery...	Boston Scientific Corporation	NPT	2014-11-19
Z-0915-2015	Class I	Lotus TAVR 23mm, Transcatheter Aortic Valve Prosthesis Premounted on Delivery...	Boston Scientific Corporation	NPT	2014-11-19
Z-0984-2015	Class II	ARTISTE MV System, Linear Accelerator (LINAC) with SysVC10A software. The intended use...	Siemens Medical Solutions USA, Inc.	IYE	2014-11-19
Z-0969-2015	Class II	VITROS 5600 Integrated System, Catalog Number 6802413, IVD --- Ortho Clinical...	Ortho-Clinical Diagnostics, Inc.	JJE	2014-11-19
Z-0968-2015	Class II	VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), Catalog Number...	Ortho-Clinical Diagnostics, Inc.	JJE	2014-11-19
Z-0967-2015	Class II	VITROS 3600 Immunodiagnostic System, Catalog Number 6802783, IVD --- Ortho Clinical...	Ortho-Clinical Diagnostics, Inc.	JJE	2014-11-19
Z-0581-2015	Class II	Conformis iTotal CR G2 Knee Replacement System Catalog/Model #: M57250600010 Intended...	ConforMIS, Inc.	JWH	2014-11-19
Z-0856-2015	Class II	Lite DM (Lite Data Manager) Software Version(s): Versions 2.0.0.19 and lower Product...	Horiba Instruments Incorporated	OUG	2014-11-19
Z-0847-2015	Class II	Replacement LED PCB Kit, part number 001840, of the Natus neoBLUE (aka neoBLUE 2)...	Natus Medical Incorporated	LBI	2014-11-19
Z-0997-2015	Class II	Philips IntelliVue TcG10; Monitor, carbon-dioxide, cutaneous. The IntelliVue TcG10 is a...	Philips North America LLC	LKD	2014-11-19
Z-0262-2016	Class II	Philips HeartStart MRx Monitor/Defibrillator Models:M3535A, M3536A, M3536M, M3536MC...	Philips North America LLC	MKJ	2014-11-19
Z-0204-2016	Class II	Philips HeartStart MRx Monitor/Defibrillators Models: M3535A and M3536A	Philips North America LLC	MKJ	2014-11-19
Z-0869-2015	Class I	KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 9.0 mm, Distributed by...	Halyard Health	BTR	2014-11-17
Z-0868-2015	Class I	KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 8.5 mm, Distributed by...	Halyard Health	BTR	2014-11-17
Z-0867-2015	Class I	KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 8.0 mm, Distributed by...	Halyard Health	BTR	2014-11-17
Z-0866-2015	Class I	KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 7.5 mm, Distributed by...	Halyard Health	BTR	2014-11-17
Z-0865-2015	Class I	KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 7.0 mm, Distributed by...	Halyard Health	BTR	2014-11-17
Z-0798-2015	Class II	PKG, CANNULA 8MM AUTOMATIC VALVE STOP COCK, W/O TROCAR, P/N 0250080172 Laparoscopic...	Stryker Corp.	KOG	2014-11-17
Z-0797-2015	Class II	PKG, 3MM X 29CM INSERT, DISSECTING FORCEPS, P/N 0250282110 Laparoscopic Manual...	Stryker Corp.	KOG	2014-11-17
Z-0796-2015	Class II	PKG, 3MM X 29CM INSERT, RIGHT ANGLE DISSECTOR, LONG JAW, P/N 0250282105 Laparoscopic...	Stryker Corp.	KOG	2014-11-17
Z-0795-2015	Class II	PKG, 3MM X 20CM INSERT, RIGHT ANGLE DISSECTOR, LONG JAW, P/N 0250282104 Laparoscopic...	Stryker Corp.	KOG	2014-11-17
Z-0794-2015	Class II	PKG., 3MM INSERT, BABCOCK FORCEPS, 29CM, P/N 0250282103 Laparoscopic Manual Instruments...	Stryker Corp.	KOG	2014-11-17
Z-0793-2015	Class II	PKG, 3MM INSERT, ATRAUMATIC GRASPER, DOUBLE ACTION, 29CM, P/N 0250282101 Laparoscopic...	Stryker Corp.	KOG	2014-11-17
Z-0792-2015	Class II	PKG, 3MM INSERT, ATRAUMATIC GRASPER, DOUBLE ACTION, 20CM, P/N 0250282100 Laparoscopic...	Stryker Corp.	KOG	2014-11-17
Z-0791-2015	Class II	PKG, 3MM INSERT, ATRAUMATIC GRASPER, SINGLE ACTION, 29CM, P/N 0250282099 Laparoscopic...	Stryker Corp.	KOG	2014-11-17
Z-0790-2015	Class II	PKG, 3MM INSERT, DORSEY GRASPER, 29CM, P/N 0250282097 Laparoscopic Manual Instruments are...	Stryker Corp.	KOG	2014-11-17
Z-0789-2015	Class II	PKG, 3MM INSERT, DORSEY GRASPER, 20CM, P/N 0250282096 Laparoscopic Manual Instruments are...	Stryker Corp.	KOG	2014-11-17
Z-0788-2015	Class II	PKG, 3MM INSERT, STRAIGHT NEEDLEHOLDER, 29CM, P/N 0250282061 Laparoscopic Manual...	Stryker Corp.	KOG	2014-11-17
Z-0787-2015	Class II	PKG, 3MM INSERT, BIOPSY PUNCH, 29CM, P/N 0250282060 Laparoscopic Manual Instruments are...	Stryker Corp.	KOG	2014-11-17
Z-0786-2015	Class II	PKG, 3MM INSERT, BIOPSY FORCEPS, 29CM, P/N 0250282059 Laparoscopic Manual Instruments are...	Stryker Corp.	KOG	2014-11-17
Z-0785-2015	Class II	PKG, 3MM INSERT, MARYLAND, FORCEPS CURVED, 29CM, P/N 0250282058 Laparoscopic Manual...	Stryker Corp.	KOG	2014-11-17
Z-0784-2015	Class II	PKG, 3MM INSERT, BULLET FORCEPS, 29CM, P/N 0250282057 Laparoscopic Manual Instruments are...	Stryker Corp.	KOG	2014-11-17
Z-0783-2015	Class II	PKG, 3MM INSERT, BLUNT GRASPER, 29CM, P/N 0250282056 Laparoscopic Manual Instruments are...	Stryker Corp.	KOG	2014-11-17
Z-0782-2015	Class II	PKG, 3MM INSERT, BLUNT WITH SPOON, GRASPER, 29CM, P/N 0250282055 Laparoscopic Manual...	Stryker Corp.	KOG	2014-11-17
Z-0781-2015	Class II	PKG, 3MM INSERT, SCHERTL GRASPER, FENESTRATED, 29CM, P/N 0250282053 Laparoscopic Manual...	Stryker Corp.	KOG	2014-11-17
Z-0780-2015	Class II	PKG, 3MM INSERT, NEEDLE NOSE FORCEPS, 29CM, P/N 0250282052 Laparoscopic Manual...	Stryker Corp.	KOG	2014-11-17
Z-0779-2015	Class II	PKG, 3MM INSERT, FUNDUS GRASPER, 29CPKG, 3MM INSERT, ALLIGATOR GRASPER, 29CM, P/N...	Stryker Corp.	KOG	2014-11-17
Z-0778-2015	Class II	PKG, 3MM INSERT, FUNDUS GRASPER, 29CM, P/N 0250282050 Laparoscopic Manual Instruments are...	Stryker Corp.	KOG	2014-11-17
Z-0777-2015	Class II	PKG, 3MM INSERT, HOOK SCISSORS, 29CM, P/N 0250282049 Laparoscopic Manual Instruments are...	Stryker Corp.	KOG	2014-11-17
Z-0776-2015	Class II	PKG, 3MM INSERT, PERITONEAL SCISSORS, 29CM, P/N 0250282048 Laparoscopic Manual...	Stryker Corp.	KOG	2014-11-17
Z-0775-2015	Class II	PKG, 3MM INSERT, METZENBAUM, CURVED, LONG SCISSORS, 29CM, P/N 0250282047 Laparoscopic...	Stryker Corp.	KOG	2014-11-17
Z-0774-2015	Class II	PKG, 3MM PEEK MULTI-FUNCTION HANDLE, P/N 0250282046 Laparoscopic Manual Instruments are...	Stryker Corp.	KOG	2014-11-17
Z-0773-2015	Class II	PKG, 3MM PEEK MONOPOLAR HANDLE, P/N 0250282045 Laparoscopic Manual Instruments are...	Stryker Corp.	KOG	2014-11-17
Z-0772-2015	Class II	PKG, 3MM INSERT, STRAIGHT NEEDLEHOLDER, 20CM, P/N 0250282014 Laparoscopic Manual...	Stryker Corp.	KOG	2014-11-17
Z-0771-2015	Class II	PKG, 3MM INSERT, BIOPSY PUNCH, 20CM, P/N 0250282013 Laparoscopic Manual Instruments are...	Stryker Corp.	KOG	2014-11-17
Z-0770-2015	Class II	PKG, 3MM INSERT, BIOPSY FORCEPS, 20CM, P/N 0250282012 Laparoscopic Manual Instruments are...	Stryker Corp.	KOG	2014-11-17