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 798 of 1190

FDA device recalls, page 798 of 1190
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-1715-2012		2.0 MM DRILL BIT, REF 71173501, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN...	Smith & Nephew, Inc.	HTW	2012-04-13
Z-1714-2012		3.2 MM IMHS(R) CP SHORT BRAD POINT DRILL, REF 71687001, QTY: (1), STERILE R, Smith &...	Smith & Nephew, Inc.	LXH	2012-04-13
Z-1713-2012		3.2 MM LONG GRADUATED BRAD POINT DRILL, REF 71780105, QTY: (1), STERILE R, Smith &...	Smith & Nephew, Inc.	LXH	2012-04-13
Z-1712-2012		3.2 MM LONG GRADUATED BRAD POINT DRILL, REF 71751149, QTY: (1), STERILE R, Smith &...	Smith & Nephew, Inc.	LXH	2012-04-13
Z-1711-2012		3.5 MM X 191 MM DRILL, REF 71173806, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis...	Smith & Nephew, Inc.	LXH	2012-04-13
Z-1710-2012		2.7 MM X 191 MM DRILL, REF 71173804, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis...	Smith & Nephew, Inc.	LXH	2012-04-13
Z-1709-2012		2.0 MM X 191 MM DRILL, REF 71173802, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis...	Smith & Nephew, Inc.	LXH	2012-04-13
Z-1708-2012		4.8 MM X 1.8 MM DRILL FOR HA COATED HALF PINS, CANNULATED, REF 71070845, QTY: (1)...	Smith & Nephew, Inc.	LXH	2012-04-13
Z-0760-2013	Class II	Rectal Retractors, titanium, item # AL07368000, a component of Varian Medical Ring and...	Varian Medical Systems, Inc.	JAQ	2012-04-12
Z-2032-2012	Class II	Gram Crystal Violet 250 mL, catalog #212525, in cartons of 4 bottles. Gram Stain Kits...	Becton Dickinson & Co	JTS	2012-04-12
Z-0759-2013	Class II	Rectal Retractors, stainless steel, item # AL07289000, a component of Varian Medical...	Varian Medical Systems, Inc.	JAQ	2012-04-12
Z-1626-2012		8F Plastic Dignity Mid-Sized CT Port w/Silicone Filled Suture Holes and w/Attachable...	Medical Components, Inc.	LJT	2012-04-12
Z-2031-2012	Class II	BD Gram Stain Kit, containing 1- 250 mL bottle of Gram Crystal Violet, and additional...	Becton Dickinson & Co	JTS	2012-04-12
Z-1535-2012		Terumo Custom Cardiovascular Procedure Kit- X-COATED PERFUSION PK FX15RE40 Product...	Terumo Cardiovascular Systems Corporation	DTZ	2012-04-12
Z-1534-2012		Terumo Custom Cardiovascular Procedure Kit- X-COATED PERFUSION PK FX15RW30 Product...	Terumo Cardiovascular Systems Corporation	DTZ	2012-04-12
Z-1533-2012		Terumo Custom Cardiovascular Procedure Kit- CUSTOM X-COATED LOW PRIME 3/8 x1/2...	Terumo Cardiovascular Systems Corporation	DTZ	2012-04-12
Z-1532-2012		Terumo Custom Cardiovascular Procedure Kit- CUSTOM X-COATED LOW PRIME 3/8 Product...	Terumo Cardiovascular Systems Corporation	DTZ	2012-04-12
Z-1531-2012		Terumo Custom Cardiovascular Procedure Kit-: CUSTOM X-COATED LOW PRIME Product...	Terumo Cardiovascular Systems Corporation	DTZ	2012-04-12
Z-1530-2012		Terumo Custom Cardiovascular Procedure Kit-PEDIATRIC PACK Product Code: 71062-01...	Terumo Cardiovascular Systems Corporation	DTZ	2012-04-12
Z-1529-2012		Terumo Custom Cardiovascular Procedure Kit-manufactured to the design and specifications...	Terumo Cardiovascular Systems Corporation	DTZ	2012-04-12
Z-1528-2012		Terumo Custom Cardiovascular Procedure Kit-manufactured to the design and specifications...	Terumo Cardiovascular Systems Corporation	DTZ	2012-04-12
Z-1527-2012		Terumo Custom Cardiovascular Procedure Kit-manufactured to the design and specifications...	Terumo Cardiovascular Systems Corporation	DTZ	2012-04-12
Z-1526-2012		Terumo Custom Cardiovascular Procedure Kit-manufactured to the design and specifications...	Terumo Cardiovascular Systems Corporation	DTZ	2012-04-12
Z-1525-2012		Terumo Custom Cardiovascular Procedure Kit-manufactured to the design and specifications...	Terumo Cardiovascular Systems Corporation	DTZ	2012-04-12
Z-1702-2012		Microsoft Amalga UIS 2009 (previously known as Microsoft Amalga Unified Intelligence...	Microsoft Corporation Health Solutions Group	JQP	2012-04-12
Z-1613-2012		Galil Medical, 17G Cryoablation Needle Holder FPRPR 4014, Rx only, Sterile EO. Product...	Galil Medical Ltd.	GEH	2012-04-12
Z-1524-2012		Terumo Custom Cardiovascular Procedure Kit-manufactured to the design and specifications...	Terumo Cardiovascular Systems Corporation	DTZ	2012-04-12
Z-1523-2012		Terumo Custom Cardiovascular Procedure Kit (manufactured to the design and...	Terumo Cardiovascular Systems Corporation	DTZ	2012-04-12
Z-1492-2012		GE Healthcare, Optima MR450W with GEM. Product Usage - The GEM Option for 1 .5T MRI...	GE Healthcare	MOS	2012-04-12
Z-1297-2015	Class II	E.CAM emission computed tomography system used to detect or image the distribution of...	Siemens Medical Solutions USA, Inc.	KPS	2012-04-11
Z-1296-2015	Class II	Symbia E is a multi-purpose SPECT system used to detect or image the distribution of...	Siemens Medical Solutions USA, Inc.	KPS	2012-04-11
Z-0056-2013	Class II	AutoMate 1250 and AutoMate 2550, Part Numbers ODL25125 and ODL25255. The AutoMate...	Siemens Healthcare Diagnostics Inc.	JQW	2012-04-11
Z-1509-2012		ARCHITECT STAT Troponin-I Reagent Kit; list numbers 2K41-28 (500 test kit); an in-vitro...	Abbott Medical	MMI	2012-04-11
Z-1519-2012		Instrumentation Laboratory (IL)HemosIL von Willebrand Factor Activity Assay Kit Part...	Instrumentation Laboratory Co.	GGP	2012-04-11
Z-0414-2013	Class II	The brand name of the device is Laser Loupes, a dentalloupe with laser eye protection...	Metrex Research	FSP	2012-04-10
Z-0384-2013	Class II	"*SENTINELCannulated Drill BitS85858.5 X 229mm (9")**CONMED LINVATEC 11311...	Linvatec Corporation	HTW	2012-04-10
Z-0383-2013	Class II	"*SENTINELCannulated Drill BitS85808 X 229mm (9")**CONMED LINVATEC 11311...	Linvatec Corporation	HTW	2012-04-10
Z-1658-2012		Becton Dickinson Phoenix Update Disks (PUD), catalog # 441107/ 448047, component of BD...	Becton Dickinson & Co	LON	2012-04-10
Z-1657-2012		Becton Dickinson Phoenix System Software, catalog # 448035/448046, component of BD...	Becton Dickinson & Co	LON	2012-04-10
Z-1787-2012	Class I	GE Healthcare, Aestiva/5 7900 SmartVent, anesthesia machine. Used in Datex-Ohmeda...	GE Healthcare	CBK	2012-04-10
Z-0164-2013	Class II	"*All in one CrossFTPunchPFT-00M4.5mm to 6.5mm**CONMED LINVATEC 11311 CONCEPT...	Linvatec Corporation	LXH	2012-04-09
Z-2029-2012	Class II	GMF-RC65 Replacement Surgical Headlight Cable for Cogent Microlink. GMF-RC65...	Gulf Fiberoptics, Inc.	FST	2012-04-09
Z-1508-2012		Product is labeled in part: Inner Label "***SMART Control Transhepatic Biliary...	Cordis US Corp.	FGE	2012-04-09
Z-1507-2012		Product is labeled in part: Inner Label "*S.M.A.R.T. Transhepatic Biliary Stent*REF...	Cordis US Corp.	FGE	2012-04-09
Z-1617-2012		TrueBeam and TrueBeam STx V1.0, 1.5, 1.6.95 and below. TrueBeam Radiotherapy Delivery...	Varian Medical Systems, Inc.	IYE	2012-04-09
Z-1495-2012		True Beam; Versions 1.0, 1.5.12.0 and below, 1.6.9.5 and below. Varian Medical...	Varian Medical Systems, Inc.	IYE	2012-04-09
Z-1518-2012		8" x 4" 16-ply Dual X-Ray Gauze, hospital fold, banded in 10's; 200 pieces per bag, 10...	Intl. Medsurg Connection, Inc.	GDY	2012-04-09
Z-1517-2012		8" x 4" 16-ply X-Ray Gauze, hospital fold, banded in 10's; 200 pieces per bag, 10 bags...	Intl. Medsurg Connection, Inc.	GDY	2012-04-09
Z-2426-2012	Class II	STERIS 5085 and 5085 SRT Surgical Tables, Product Usage: The 5085 is a general...	STERIS Corporation	GDC	2012-04-06
Z-1496-2012		Doctors Research Group Kryptonite Bone Cement packaged in 5cc and 10 cc Kits: Product...	Doctor'S Research Group, Inc.	GXP	2012-04-06