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 690 of 1191

FDA device recalls, page 690 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-2563-2014	Class II	Roche cobas IT 1000 Product Usage: Intended Use: An electronic device intended to...	Roche Diagnostics GmbH	JQP	2014-07-31
Z-2607-2014	Class II	CLAW II STRAIGHT PLATE ORTHOLOC 3DSi, LENGTH 25mm x 25mm, REF 40242525, 1 EACH, Rx ONLY...	Wright Medical Technology Inc	HRS	2014-07-30
Z-2608-2014	Class II	CLAW II STRAIGHT PLATE ORTHOLOC 3DSi, LENGTH 20mm x 25mm, REF 40242025, 1 EACH, Rx ONLY...	Wright Medical Technology Inc	HRS	2014-07-30
Z-2605-2014	Class II	CLAW II STRAIGHT PLATE ORTHOLOC 3DSi, LENGTH 20mm x 20mm, REF 40242020, 1 EACH, Rx ONLY...	Wright Medical Technology Inc	HRS	2014-07-30
Z-2604-2014	Class II	CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 30mm, REF 40240230, 1 EACH, Rx ONLY, NON...	Wright Medical Technology Inc	HRS	2014-07-30
Z-2603-2014	Class II	CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 25mm, REF 40240225, 1 EACH, Rx ONLY, NON...	Wright Medical Technology Inc	HRS	2014-07-30
Z-2602-2014	Class II	CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 20mm, REF 40240220, 1 EACH, Rx ONLY, NON...	Wright Medical Technology Inc	HRS	2014-07-30
Z-2601-2014	Class II	CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 15mm, REF 40240215, 1 EACH, Rx ONLY, NON...	Wright Medical Technology Inc	HRS	2014-07-30
Z-2600-2014	Class II	CLAW 3.5mm PLATE CHARLOTTE F&A SYSTEM, SIZE 30mm, 2 HOLE, USE WITH 3.5mm CLAW SCREW, REF...	Wright Medical Technology Inc	HRS	2014-07-30
Z-2599-2014	Class II	CLAW PLATE 20mm INTERAXIS CHARLOTTE F&A SYSTEM, REF 40S20020, 1 EACH, Rx ONLY, NON...	Wright Medical Technology Inc	HRS	2014-07-30
Z-2624-2014	Class II	Integra Container Lid, Size, Red; Container Lid, Size, Blue; Container Lid, Size, Red...	Miltex, Inc.	KCT	2014-07-30
Z-2545-2014	Class II	Zimmer Gender Solution Patello-Femoral Joint (PFJ) System Patello-Femoral Trochlea...	Zimmer GmbH	KRR	2014-07-30
Z-2543-2014	Class II	Zimmer PERSONA Distal Valgus Alignment Guide, Nonsterile. orthopedic surgical instrument...	Zimmer GmbH	LXH	2014-07-30
Z-2719-2014	Class II	Percutaneous Trial Lead Kit Model 3086 (8 ch percutaneous lead). Used as part of the St...	Abbott Medical	GZB	2014-07-29
Z-2718-2014	Class II	Percutaneous Trial Lead Kit Model 3046 (4 ch percutaneous lead). Used as part of the St...	Abbott Medical	GZB	2014-07-29
Z-2628-2014	Class II	BD BBL Vancomycin Screen Agar Catalog number 222204 Vancomycin Screen Agar is used to...	Becton Dickinson & Co	JWY	2014-07-28
Z-2597-2014	Class II	RADIANCE v. 2.4X, 2.5X and 2.6X Product Usage: RADIANCE is a data processing...	Radiometer America, Inc	JQP	2014-07-28
Z-2611-2014	Class II	Illumina Worklist Manager (IWM) (software v1.0.15), a component of Illumina MiSeqDx...	Illumina, Inc.	PFF	2014-07-28
Z-2713-2014	Class II	The Symbia Intevo series consists of the Intevo 16, Intevo 6 and Intevo 2. This manual...	Siemens Medical Solutions USA, Inc.	KPS	2014-07-28
Z-2712-2014	Class II	The Symbia T Series consists of the T16, T6, T2, and T. The Symbia T integrates...	Siemens Medical Solutions USA, Inc.	KPS	2014-07-28
Z-2693-2014	Class II	Minstrel (with scale) Product Usage: is a mobile passive hoist. It is intended for...	ArjoHuntleigh Polska Sp. zo.o.	FSA	2014-07-28
Z-2237-2014	Class II	IntelliSpace Portal (ISP) DX/HX/EX, IntelliSpace Portal (ISP) IX, and IntelliSpace Portal...	Philips North America LLC	JAK	2014-07-27
Z-0101-2015	Class II	Ultra Battery 1 Model: TA-UB1 NSN: 6515-01-592-5803 The Ultra Battery 1 (TA-UB1) is a...	Estill Medical Technologies, Inc	BSB	2014-07-25
Z-2560-2014	Class II	ACL Sleeve Installation Tool Sizes: 6mm, 6.5mm, 7.0mm, 7.5mm, 8.0mm, 8.5mm, 9.0mm...	Orthopediatrics Corp	MBI	2014-07-25
Z-2635-2014	Class II	SUN DASH RADIUS 252 PN 8000809705. The device is intended to be used for the tanning of...	JK Products & Services, Inc	LEJ	2014-07-25
Z-2670-2014	Class II	0.9% Sodium Chloride Injection, USP BD PosiFlush(TM) SF Saline Flush Syringe 10 mL...	Centurion Medical Products, LP	NGT	2014-07-25
Z-2291-2014	Class II	GE Healthcare, Discovery XR656P/N 5374989/5397837 is intended to generate digital...	GE Healthcare	lZE	2014-07-25
Z-2589-2014	Class II	GALT VALVED TEARAWAY KIT GALT VTI w/ Sideport Stainless Steel Dbl Flex. J-St RX ONLY...	Galt Medical Corp	DYB	2014-07-25
Z-2588-2014	Class II	GALT VALVED TEARAWAY INTRODUCER SET GALT VTI RX ONLY UNITS 7 STERILE EO Product...	Galt Medical Corp	DYB	2014-07-25
Z-0065-2015	Class II	Stryker T2 Tibia System Nail Insertion Sleeve, Elastic, Sterile, a) REF 1806-1406S, SPI...	Howmedica Osteonics Corp	HSB	2014-07-24
Z-2252-2014	Class II	Philips IntelliSpace PACS 4.4 image management systems performs digital image processing...	Philips North America LLC	LLZ	2014-07-24
Z-2618-2014	Class II	The BD MAX MRSA Assay, catalogue #442953. An automated qualitative in vitro diagnostic...	Becton Dickinson & Co	NQX	2014-07-23
Z-2231-2014	Class II	23.5 Deg Rasp Handle Assy- RIGHT Nonsterile	Zimmer GmbH	LXH	2014-07-23
Z-2230-2014	Class II	23.5 Deg Rasp Handle Assy- LEFT Nonsterile	Zimmer GmbH	LXH	2014-07-23
Z-2229-2014	Class II	VER2 HANDLE, PIN REWORK, RT Nonsterile	Zimmer GmbH	LXH	2014-07-23
Z-2228-2014	Class II	VER2 HANDLE, PIN REWORK, LT Nonsterile	Zimmer GmbH	LXH	2014-07-23
Z-2227-2014	Class II	Double Offset Rasp Handle, Right Hand A/S Rasp Handle (Right)	Zimmer GmbH	LXH	2014-07-23
Z-2226-2014	Class II	Double Offset Rasp Handle, Left Hand A/S Rasp Handle (Left)	Zimmer GmbH	LXH	2014-07-23
Z-2225-2014	Class II	VER2 D8L OFFSET RASP HANDLE, RT Nonsterile	Zimmer GmbH	LXH	2014-07-23
Z-2224-2014	Class II	VER2 DBL OFFSET RASP HANDLE, LT Nonsterile	Zimmer GmbH	LXH	2014-07-23
Z-2223-2014	Class II	Vl DBL OFFST WI LRG STPL, RT Nonsterile	Zimmer GmbH	LXH	2014-07-23
Z-2222-2014	Class II	Double Offset Rasp Handle, Right Hand Nonsterile	Zimmer GmbH	LXH	2014-07-23
Z-2221-2014	Class II	Double Offset Rasp Handle, Left Hand Nonsterile	Zimmer GmbH	LXH	2014-07-23
Z-2220-2014	Class II	Double Offset Rasp Handle, Right Hand Nonsterile	Zimmer GmbH	LXH	2014-07-23
Z-2219-2014	Class II	VI DBL OFFST W/ LRG STPL, LT Nonsterile	Zimmer GmbH	LXH	2014-07-23
Z-2218-2014	Class II	Double Offset Rasp Handle, Left Hand Nonsterile	Zimmer GmbH	LXH	2014-07-23
Z-2217-2014	Class II	Double Offset Rasp Handle, Left Hand Nonsterile	Zimmer GmbH	LXH	2014-07-23
Z-2216-2014	Class II	Double Offset Rasp Handle, Left Hand Nonsterile	Zimmer GmbH	LXH	2014-07-23
Z-1932-2015	Class II	ICT Serum Calibrator REF 146-03. For use in the calibration of the serum Sodium...	Abbott Medical	CEM	2014-07-22
Z-2673-2014	Class II	BD PosiFlush SF Saline Flush Syringe 0.9 Sodium Chloride Injection, USP 10 mL REF...	Becton Dickinson & Co	NGT	2014-07-22