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 2026-10-15, the FDA export date. FDA medical device recall database

59,486 records, page 794 of 1190

FDA device recalls, page 794 of 1190
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-1832-2012	Class II	SARNS HIGH-FLOW AORTIC ARCH CANNULA: 5.2 MM (16 FR) 00 WITH 3/8" CONNECTOR, 7.5" (19 CM)...	Terumo Cardiovascular Systems Corporation	DWF	2012-05-09
Z-1894-2012	Class II	CPB CATHETER KIT-DR BARTLES Product Usage: The Sarns Cardioplegia Cannula and...	Terumo Cardiovascular Systems Corporation	DWF	2012-05-09
Z-1893-2012	Class II	CPB CATHETER KIT-DR VANTRIGHT Product Usage: The Sarns Cardioplegia Cannula and...	Terumo Cardiovascular Systems Corporation	DWF	2012-05-09
Z-1892-2012	Class II	CPB CATHETER KIT-DR VANTRIGHT Product Usage: The Sarns Cardioplegia Cannula and...	Terumo Cardiovascular Systems Corporation	DWF	2012-05-09
Z-1891-2012	Class II	CPB CATHETER KIT- DR HENDRICKSO Product Usage: The Sarns Cardioplegia Cannula and...	Terumo Cardiovascular Systems Corporation	DWF	2012-05-09
Z-1890-2012	Class II	CPB CATHETER KIT- DR OWEN Product Usage: The Sarns Cardioplegia Cannula and...	Terumo Cardiovascular Systems Corporation	DWF	2012-05-09
Z-1889-2012	Class II	CPB CATHETER KIT-DR GERHARDT Product Usage: The Sarns Cardioplegia Cannula and...	Terumo Cardiovascular Systems Corporation	DWF	2012-05-09
Z-1888-2012	Class II	CUSTOM CPB CATHETER KIT-DR. Product Usage: The Sarns Cardioplegia Cannula and...	Terumo Cardiovascular Systems Corporation	DWF	2012-05-09
Z-1887-2012	Class II	X-COATED H/L PK W/FX15RW40 Product Usage: The Sarns Cardioplegia Cannula and...	Terumo Cardiovascular Systems Corporation	DWF	2012-05-09
Z-1886-2012	Class II	X-COATED FX25RW H/L PACK Product Usage: The Sarns Cardioplegia Cannula and...	Terumo Cardiovascular Systems Corporation	DWF	2012-05-09
Z-1885-2012	Class II	MAYO MN XCOATED 3/8X1/2 AV Product Usage: The Sarns Cardioplegia Cannula and...	Terumo Cardiovascular Systems Corporation	DWF	2012-05-09
Z-1884-2012	Class II	X-COATED SMALL PATIENT PACK Product Usage: The Sarns Cardioplegia Cannula and...	Terumo Cardiovascular Systems Corporation	DWF	2012-05-09
Z-1883-2012	Class II	X-COATED SMALL PATIENT PACK Product Usage: The Sarns Cardioplegia Cannula and...	Terumo Cardiovascular Systems Corporation	DWF	2012-05-09
Z-1882-2012	Class II	X-COATED TRANSPLANT PACK Product Usage: The Sarns Cardioplegia Cannula and...	Terumo Cardiovascular Systems Corporation	DWF	2012-05-09
Z-1881-2012	Class II	XC HEART/LUNG PACK W/SX25RX Product Usage: The Sarns Cardioplegia Cannula and...	Terumo Cardiovascular Systems Corporation	DWF	2012-05-09
Z-1880-2012	Class II	INDIANA/OHIO HEART Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent...	Terumo Cardiovascular Systems Corporation	DWF	2012-05-09
Z-1879-2012	Class II	FX PACK Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters...	Terumo Cardiovascular Systems Corporation	DWF	2012-05-09
Z-1878-2012	Class II	SARNS ANTEGRADE CARDIOPLEGIA CANNULA: ROOT INFUSION CANNULA WITH 12-GAUGE BLUE...	Terumo Cardiovascular Systems Corporation	DWF	2012-05-09
Z-1877-2012	Class II	SARNS ANTEGRADE CARDIOPLEGIA CANNULA: ROOT INFUSION CANNULA WITH 14-GAUGE WHITE...	Terumo Cardiovascular Systems Corporation	DWF	2012-05-09
Z-1876-2012	Class II	SARNS ANTEGRADE: CARDIOPLEGIA CANNULA: ROOT INFUSION VENT/CATHETER WITH 14- GAUGE WHITE...	Terumo Cardiovascular Systems Corporation	DWF	2012-05-09
Z-1875-2012	Class II	Sarns Antegrade Cardioplegia Cannula: ROOT INFUSTION VENT CATHETER WITH 12 GAUGE BLUE...	Terumo Cardiovascular Systems Corporation	DWF	2012-05-09
Z-2253-2012	Class I	ON-Q pump with ONDEMAND bolus button, ON-Q C-bloc with ONDEMAND; ON-Q C-bloc with Select...	Halyard Health	MEB	2012-05-08
Z-1869-2012	Class II	Siemens Dimension Vista(R) System B12 Flex(R) Reagent Cartridge (K6442) B12 Flex Reagent...	Siemens Healthcare Diagnostics Inc.	CDD	2012-05-08
Z-2044-2014	Class II	Lynx TM20 Torquemaster Low Speed Handpiece MTI Dental Products	Mti Precision Products	EFB	2012-05-07
Z-2279-2012	Class II	V Series Patient Monitors; Mindray DS USA, Inc. Product Usage: The V Series Monitor is...	Datascope Corp.	MHX	2012-05-07
Z-1791-2012	Class II	The Brilliance iCT and iCT SP are Computed Tomography X-Ray Systems intended to produce...	Philips North America LLC	JAK	2012-05-07
Z-1820-2012	Class II	USA-002 Rev A brochure is a two sided tri-fold printed marketing brochure describing the...	Non-Invasive Monitoring Systems, Inc.	IRO	2012-05-07
Z-1819-2012	Class II	US-001 Rev A brochure is a two sided tri-fold printed marketing brochure describing the...	Non-Invasive Monitoring Systems, Inc.	IRO	2012-05-07
Z-1688-2012		The Brilliance iCT and iCT SP are Computed Tomography X-Ray Systems intended to produce...	Philips North America LLC	JAK	2012-05-07
Z-2183-2012	Class II	BeautyAngel Health Fitness Natural Collagen Stimulation Anti Aging For human use.	JK Products & Services, Inc	000	2012-05-07
Z-1707-2012		Heparin Lock Flush Solution 100 Unit/mL, USP 3 ml, 4 ml, 5mL, 6 ml fill in a 10 ml...	Excelsior Medical LLC	NZW	2012-05-07
Z-1682-2012		Altrus Thermal Tissue Fusion, Tissue Fusion Handpiece 10 mm O.D., 23 cm Shaft, Catalog...	ConMed Corporation	GEI	2012-05-07
Z-1681-2012		Altrus Thermal Tissue Fusion, Tissue Fusion Handpiece 5 mm O.D., 16 cm Shaft, Catalog...	ConMed Corporation	GEI	2012-05-07
Z-1680-2012		Altrus Thermal Tissue Fusion, Tissue Fusion Handpiece 5 mm O.D., 23 cm Shaft, Catalog...	ConMed Corporation	GEI	2012-05-07
Z-1679-2012		Altrus Thermal Tissue Fusion, Tissue Fusion Handpiece 5 mm O.D., 36 cm Shaft, Catalog...	ConMed Corporation	GEI	2012-05-07
Z-1678-2012		Altrus Energy Source REF 60-9500-120 Tissue Fusion Energy Source ConMed Corporation 525...	ConMed Corporation	GEI	2012-05-07
Z-1956-2012	Class II	CIVCO VirtuTRAX Instrument Navigator, Reusable non-sterile general purpose driveBAY...	CIVCO Medical Instruments Co., Inc.	IYO	2012-05-07
Z-1955-2012	Class II	CIVCO General Purpose Sensor, Non-sterile reusable general purpose electromagnetic...	CIVCO Medical Instruments Co., Inc.	IYO	2012-05-07
Z-1954-2012	Class II	CIVCO General Purpose Sensor, Non-sterile reusable general purpose electromagnetic sensor...	CIVCO Medical Instruments Co., Inc.	IYO	2012-05-07
Z-1953-2012	Class II	CIVCO General Purpose Sensor, Non-sterile reusable general purpose electromagnetic sensor...	CIVCO Medical Instruments Co., Inc.	IYO	2012-05-07
Z-1952-2012	Class II	CIVCO VirtuTRAX Instrument Navigator, Reusable non-sterile general purpose driveBAY...	CIVCO Medical Instruments Co., Inc.	IYO	2012-05-07
Z-0199-2016	Class II	Robotic hand accessory to InMotion Arm, rehabilitation robot.	Interactive Motion Technologies, Inc.	IKK	2012-05-05
Z-2037-2012	Class II	Hitachi Scenaria CT System Software Product Usage: The Scenaria system is indicated to...	FUJIFILM Healthcare Americas Corporation	JAK	2012-05-04
Z-1940-2012	Class II	Depuy Spine Side Fire Needles 13G X 4IN Side-Fire Needle, part of the Confidence Spinal...	DePuy Mitek, Inc.	OAR	2012-05-04
Z-1939-2012	Class II	Depuy Spine Side Fire Needles 11G X 6IN Side-Fire Needle, part of the Confidence Spinal...	DePuy Mitek, Inc.	OAR	2012-05-04
Z-1938-2012	Class II	Depuy Spine Side Fire Needles 11G X 4IN, part of the Confidence Spinal Cement...	DePuy Mitek, Inc.	OAR	2012-05-04
Z-1937-2012	Class II	Depuy Spine Side Fire Needles 13G X 6IN, part of the Confidence Spinal Cement...	DePuy Mitek, Inc.	OAR	2012-05-04
Z-1946-2012	Class II	Safedraw Venous Close Loop System, Blood Sampling Set, packaged in a tyvek bag...	Argon Medical Devices, Inc	DSK	2012-05-04
Z-1624-2012		Pelleve Non-Ablative Wrinkle Treatment Handpiece, Product Codes D110FSHP, D115FSHP...	Ellman International, Inc.	GEI	2012-05-04
Z-2492-2012	Class II	Tabs Professional Voice + Monitor, with wire bracket, Model 25223. Stanley Security...	Securitas Healthcare LLC	KMI	2012-05-04