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 2026-10-21, the FDA export date. FDA medical device recall database

59,528 records, page 711 of 1191

FDA device recalls, page 711 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-1463-2014	Class II	FRAXEL DUAL 1550/1927 Laser System, (FRAXEL SR 1500 DUAL Laser System), for...	Solta Medical, Inc.	ONG	2014-03-20
Z-1435-2014	Class II	7mm Drain Kit Flat 3/4 Perforated with 100ml S-Vac Bulb Evacuator, Sterile (10/case) 10...	Aspen Surgical Products, Inc.	GCY	2014-03-20
Z-1434-2014	Class II	7mm Drain Kit Flat Full Perforated with Trocar and 100ml S-Vac Bulb Evacuator, Sterile...	Aspen Surgical Products, Inc.	GCY	2014-03-20
Z-1433-2014	Class II	19FR Drain Kit Flat Full Perforated with Trocar, Saber 100ml Bulb and 3CSystem, Sterile...	Aspen Surgical Products, Inc.	GCY	2014-03-20
Z-1432-2014	Class II	15FR Drain Kit Round End Perforated with Trocar and 100ml S-Vac Bulb Evacuator, Sterile...	Aspen Surgical Products, Inc.	GCY	2014-03-20
Z-1431-2014	Class II	10mm Drain Kit Flat Full Perforated with 100ml S-Vac Bulb Evacuator, Sterile...	Aspen Surgical Products, Inc.	GCY	2014-03-20
Z-1430-2014	Class II	7mm Drain Kit Flat Full Perforated with 100ml S-Vac Bulb Evacuator, Sterile...	Aspen Surgical Products, Inc.	GCY	2014-03-20
Z-1429-2014	Class II	10mm Drain Kit Flat 3/4 Perforated with 100ml S-Vac Bulb Evacuator, Sterile...	Aspen Surgical Products, Inc.	GCY	2014-03-20
Z-1428-2014	Class II	10mm Drain Kit Flat Full Perforated with Trocar and 100ml S-Vac Bulb Evacuator, Sterile...	Aspen Surgical Products, Inc.	GCY	2014-03-20
Z-1427-2014	Class II	10mm Drain Kit Flat 3/4 Perforated with Trocar and 100ml S-Vac Bulb Evacuator, Sterile...	Aspen Surgical Products, Inc.	GCY	2014-03-20
Z-1426-2014	Class II	19FR Drain Kit Full Fluted with Trocar and 100ml S-Vac Bulb, Sterile (10/case) Intended...	Aspen Surgical Products, Inc.	GCY	2014-03-20
Z-1425-2014	Class II	15FR Drain Kit Full Fluted with Trocar and 100ml S-Vac Bulb, Sterile (10/case) Intended...	Aspen Surgical Products, Inc.	GCY	2014-03-20
Z-1424-2014	Class II	10FR Drain Kit Full Fluted with Trocar and 100ml S-Vac Bulb, Sterile (10/case) Intended...	Aspen Surgical Products, Inc.	GCY	2014-03-20
Z-1423-2014	Class II	7mm Drain Kit Fluted 4 Channel with 100ml S-Vac Bulb, Sterile (10/case) Intended for...	Aspen Surgical Products, Inc.	GCY	2014-03-20
Z-1422-2014	Class II	Saber 100ml Infection Control PVC Bulb Evacuator, Sterile (10/case) Intended to provide...	Aspen Surgical Products, Inc.	GCY	2014-03-20
Z-1421-2014	Class II	Saber 100ml Infection Control PVC Bulb with 150ml 3C System, Sterile (10/case) Intended...	Aspen Surgical Products, Inc.	GCY	2014-03-20
Z-1420-2014	Class II	15FR Drain Kit, Flat Full Perforated with Trocar, Saber 100ml Bulb and 3C System, Sterile...	Aspen Surgical Products, Inc.	GCY	2014-03-20
Z-1419-2014	Class II	10FR Drain Kit, Flat Full Perforated with Trocar, Saber 100ml Bulb and 3C System, Sterile...	Aspen Surgical Products, Inc.	GCY	2014-03-20
Z-1418-2014	Class II	10mm Drain Kit, Flat Full Perforated, Saber 100ml Bulb and 3C System Sterile...	Aspen Surgical Products, Inc.	GCY	2014-03-20
Z-1417-2014	Class II	7mm Drain Kit, Flat Full Perforated, Saber 100ml Bulb and 3C System Sterile...	Aspen Surgical Products, Inc.	GCY	2014-03-20
Z-1538-2014	Class II	Joseph Lamelas Atrial Lift System, Model Number MI-ALS-001. A single surgical instrument...	Biorep Technologies, Inc.	DWS	2014-03-19
Z-1609-2014	Class II	Ultrasound USB needles, with 30 degree bevel, packaged individually, 10 needles/box...	RM Temena GmbH	BSP	2014-03-19
Z-1608-2014	Class II	Ultrasound needles, 22G (0.7 mm) x 50mm, packaged individually, 10 needles/box, item...	RM Temena GmbH	BSP	2014-03-19
Z-1606-2014	Class II	Tennis Elbow Support, Neoprene***LATEX FREE" Product Usage: Provides compression and...	Zimmer GmbH	DWL	2014-03-19
Z-1605-2014	Class II	Hinged Knee Support***LATEX FREE" Product Usage: Provide added lateral stability and...	Zimmer GmbH	DWL	2014-03-19
Z-1604-2014	Class II	Cartilage Knee Brace***LATEX FREE" Product Usage: Used in the treatment and support...	Zimmer GmbH	DWL	2014-03-19
Z-1603-2014	Class II	DROP LOK" Knee Brace***LATEX FREE" Product Usage: Used in the treatment, support, and...	Zimmer GmbH	DWL	2014-03-19
Z-1647-2014	Class II	Dimension Vista CSA and CSAE The Cyclosporine method is an in vitro diagnostic test for...	Siemens Healthcare Diagnostics Inc.	MKW	2014-03-19
Z-1459-2014	Class II	SmartSite Extension Set, Model No. 20029E, intravascular administration set.	CareFusion 303, Inc	FPA	2014-03-19
Z-2559-2014	Class III	Verigene CYP2C19 Nucleic Acid Test (CYP2C19 Test). Each CYP2C19 kit consists of 20...	Luminex Corporation	NTI	2014-03-18
Z-1632-2014	Class II	MaXair True Low Air Loss Mattress Replacement System, True Air Technologies, Inc.	Aim Manufacturing, LLC	FNM	2014-03-18
Z-1631-2014	Class II	ECATS E 850 Bariatric Bed, True Air Technologies, Inc.	Aim Manufacturing, LLC	OSI	2014-03-18
Z-1630-2014	Class II	JK Bariatric Beds, True Air Technologies, Inc.	Aim Manufacturing, LLC	OSI	2014-03-18
Z-1247-2014	Class II	2.5MM Aggressive Blade Known as a Sinuscopic Shaver Blade, this device is composed of a...	Stryker Corp.	ERL	2014-03-18
Z-1336-2014	Class II	Playtex Nurser Deluxe Double Electric Breast Pump, Model X06578AO, powered by a 12V DC...	Energizer Personal Care	HGX	2014-03-18
Z-2056-2014	Class II	BAM (SHAPE) ARM, RIGHT, an articulating, arm bracket that is attached to the service head...	STRYKER Communications, Inc.	BRY	2014-03-17
Z-2055-2014	Class II	BAM (SHAPE) ARM, LEFT, an articulating, arm bracket that is attached to the service head...	STRYKER Communications, Inc.	BRY	2014-03-17
Z-2054-2014	Class II	SHAPE ARM, SINGLE WITH GCX MOUNT, an articulating, arm bracket that is attached to the...	STRYKER Communications, Inc.	BRY	2014-03-17
Z-2053-2014	Class II	SHAPE ARM, DUAL SH2, an articulating, arm bracket that is attached to the service head of...	STRYKER Communications, Inc.	BRY	2014-03-17
Z-1503-2014	Class II	Digital Diagnost, stationary radiographic system; Models...	Philips North America LLC	MQB	2014-03-17
Z-2052-2014	Class II	SHAPE ARM, SINGLE, an articulating, arm bracket that is attached to the service head of...	STRYKER Communications, Inc.	BRY	2014-03-17
Z-1474-2014	Class II	Oxoid Legionella Pneumo Groups 2-14, DR0802M, containing 50 tests per box. The box...	Remel Inc	LIB	2014-03-17
Z-1473-2014	Class II	Oxoid Legionella Latex Test, DR0800M, containing 50 tests per box. The box contains a...	Remel Inc	LIB	2014-03-17
Z-1318-2014	Class II	3M" Steri-Vac" Gas Sterilizer/Aerators, Model #'s 4XL,5XL, 8XL The 3M" Steri-Vac" Gas...	3M Company	FLF	2014-03-17
Z-1444-2014	Class II	Smiths Medical HOTLINE Fluid Warming Set L-80. Product Usage: intended for the...	Abbott Medical	LGZ	2014-03-17
Z-1443-2014	Class II	Smiths Medical HOTLINE Fluid Warming Set L-70. Product Usage: intended for the delivery...	Abbott Medical	LGZ	2014-03-17
Z-0019-2015	Class II	ArjoHuntleigh Contoura C1000 series beds are designed to accommodate patients weighing up...	Arjohuntleigh AB	FNL	2014-03-17
Z-1836-2014	Class II	The Claymount Harmony is a grid cabinet designed to accept a digital x-ray imaging...	Varex Imaging Nederland B.V.	IXY	2014-03-15
Z-1835-2014	Class II	The Claymount Harmony is a grid cabinet designed to accept a digital x-ray imaging...	Varex Imaging Nederland B.V.	IXY	2014-03-15
Z-1621-2014	Class II	InterValve V8 Balloon Aortic Valvuloplasty Catheter, model 172212C110, 192412C110...	Intervalve, Inc.	OZT	2014-03-14