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 774 of 1190

FDA device recalls, page 774 of 1190
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-0619-2013	Class III	Analyzing system consists of a small and portable analyzer and plastic microcuvettes. The...	HemoCue AB	JIQ	2012-11-07
Z-0713-2013	Class II	DePuy Spine VIPER POLY SCREW 5.5 10X100MM Tl Product Code: 1867-15-199 Spinal...	DePuy Spine, Inc.	NKB	2012-11-07
Z-0712-2013	Class II	DePuy Spine VIPER POLY SCREW 5.5 10 X 80MM Tl Product Code: 1867-15-180 Spinal...	DePuy Spine, Inc.	NKB	2012-11-07
Z-0711-2013	Class II	DePuy Spine VIPER POLY SCREW 5.5 10 X 70MM Tl Product Code: 1867-15-170 Spinal...	DePuy Spine, Inc.	NKB	2012-11-07
Z-0710-2013	Class II	DePuy Spine VIPER POLY SCREW 5.5 9 X100MM Tl Product Code: 1867-15-999 Spinal...	DePuy Spine, Inc.	NKB	2012-11-07
Z-0709-2013	Class II	DePuy Spine VIPER POLY SCREW 5.5 9 X 80MM Tl Product Code: 1867-15-980 Spinal...	DePuy Spine, Inc.	NKB	2012-11-07
Z-0708-2013	Class II	DePuy Spine VIPER POLY SCREW 5.5 9 X70MM Tl Product Code: 1867-15-970 Spinal...	DePuy Spine, Inc.	NKB	2012-11-07
Z-0707-2013	Class II	DePuy Spine VIPER POLY SCREW 5.5 8 X100MM Tl Product Code: 1867-15-899 Spinal...	DePuy Spine, Inc.	NKB	2012-11-07
Z-0706-2013	Class II	DePuy Spine VIPER POLY SCREW 5.5 8 X80MM Tl Product Code: 1867-15-880 Spinal...	DePuy Spine, Inc.	NKB	2012-11-07
Z-0705-2013	Class II	DePuy Spine VIPER POLY SCREW 5.5 8 X70MM Tl Product Code: 1867-15-870 Spinal...	DePuy Spine, Inc.	NKB	2012-11-07
Z-0758-2013	Class II	Ethicon Endo-Surgery Inc. The ENSEAL G2 Tissue Sealers are indicated for bipolar...	Ethicon Endo-Surgery Inc	GEI	2012-11-06
Z-0556-2013	Class II	Invacare Height Adjustable (walking) Canes, Model Numbers: 8916, 8917, and 40918-6...	Invacare GmbH	KHY	2012-11-06
Z-0570-2013	Class II	BD Phoenix PMIC-108 Panels, Catalog number 448418, labeled in part ***Becton, Dickinson...	Becton Dickinson & Co	LON	2012-11-06
Z-0442-2013	Class II	Echo Bi-Metric Press-Fit Stems/Echo Bi-Metric 11mm x 135mm Collarless Porous Stem...	Zimmer GmbH	KWA	2012-11-06
Z-0870-2013	Class II	MEDRAD Hand Controller Sheath, Catalog number AVA 500 HCS/3010903, for cardiac...	Medrad, Inc.	DXT	2012-11-05
Z-0788-2013	Class II	Exactech NOVATION CROWN CUP +5mm LATERALIZED LINER, Use with Crown Cup Only, GXL UHMWPE...	Exactech, Inc.	LZO	2012-11-05
Z-0787-2013	Class II	Exactech NOVATION CROWN CUP, NEUTRAL LINER, Use with Crown Cup Only, GXL UHMWPE, SN...	Exactech, Inc.	LZO	2012-11-05
Z-0717-2013	Class II	Lifestyles Pleasure Collection 30 Premium Lubricated Condoms Assortment of Ultra...	Ansell Healthcare Products LLC	HIS	2012-11-05
Z-0644-2013	Class II	Laparoscope, general; plastic surgery Used for general, abdominal, gynecological and...	Applied Medical Resources Corp	CGJ	2012-11-05
Z-0534-2013	Class II	Arobella Medical 6mm Qurette used with the Arobella Medical AR1000 Wound Therapy System...	Arobella Medical, LLC	LFL	2012-11-05
Z-0572-2013	Class II	The Access hLH assay is a paramagnetic particle, chemiluminescent immunoassay for the...	Siemens Healthcare Diagnostics Inc.	CEP	2012-11-05
Z-0559-2013	Class II	MAYFIELD Composite Series Skull Clamps, Model A3059, 510(k) #K120633. The MAYFIELD Skull...	Integra LifeSciences Corporation	HBL	2012-11-05
Z-0558-2013	Class II	MAYFIELD Composite Series Base Unit, Model A3101, a Swivel Adaptor (A3018) is an...	Integra LifeSciences Corporation	FWZ	2012-11-05
Z-0531-2013	Class II	Varian brand ARIA Radiation Oncology, ARIA Oncology Information System Radiation...	Varian Medical Systems, Inc.	IYE	2012-11-05
Z-0453-2013	Class II	OmniGuide BP-ROBOTIC ( BeamPath Robotic), Single Use Cat. # BP-ROBOTIC The OmniGuide...	Omni-Guide Holdings, Inc.	GEX	2012-11-05
Z-0434-2013	Class II	SenTec V-Sign Membrane Changer Insert (VS-MCI), 5 pieces. The SenTec V-Sign Membrane...	Sentec AG	LKD	2012-11-05
Z-0433-2013	Class II	SenTec V-Sign Membrane Changer (VS-MC), 9 pieces. The SenTec V-Sign Membrane Changer is...	Sentec AG	LKD	2012-11-05
Z-2058-2013	Class II	Synthes Trauma Nail System. The devices are indication for bone fixation.	Synthes GmbH	HSB	2012-11-02
Z-0650-2013	Class II	Rigid Tip Suction Wand Non sterile bulk devices (S112468N, S120196N, and S120197N) were...	California Medical Laboratories, Inc.	DTS	2012-11-02
Z-0649-2013	Class II	Sterile Rigid Tip Suction Wand The Suction Wands are indicated for use to remove excess...	California Medical Laboratories, Inc.	DTS	2012-11-02
Z-0627-2013	Class II	Maquet Yuno Extension Table Device Maquet GmbH & Co. KG Kehler Strabe...	Maquet Cardiovascular Us Sales, LLC	FWZ	2012-11-02
Z-0565-2013	Class II	BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators are anesthesia gas...	GE Healthcare	BSZ	2012-11-02
Z-0427-2013	Class II	KING LAD Flexible ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case "Size...	King Systems Corporation.	CAE	2012-11-02
Z-0426-2013	Class II	KING LAD Flexible ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case "Size...	King Systems Corporation.	CAE	2012-11-02
Z-0425-2013	Class II	KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 20 devices/case Size...	King Systems Corporation.	CAE	2012-11-02
Z-0424-2013	Class II	KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case Size 5...	King Systems Corporation.	CAE	2012-11-02
Z-0423-2013	Class II	KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case Size 4...	King Systems Corporation.	CAE	2012-11-02
Z-0422-2013	Class II	KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie10 devices/case Size 3 /...	King Systems Corporation.	CAE	2012-11-02
Z-0421-2013	Class II	KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 5 / Adult...	King Systems Corporation.	CAE	2012-11-02
Z-0420-2013	Class II	KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 4 / Adult...	King Systems Corporation.	CAE	2012-11-02
Z-0419-2013	Class II	KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 3 / Child...	King Systems Corporation.	CAE	2012-11-02
Z-0418-2013	Class II	KING LAD SILI CONE SINGLE USE, King Systems devices/case, ETO Sterile. Size 2 / Infant...	King Systems Corporation.	CAE	2012-11-02
Z-0616-2013	Class II	Brookstone Heated Body Bean, electrically heated SKU numbers: 734863 (Blue), 734864...	Brookstone Company, Inc.		2012-11-02
Z-2871-2016	Class II	CADstream software. Product Usage: CADstream is an image processing system designed to...	Merge Healthcare Incorporated	LLZ	2012-11-01
Z-1161-2013	Class III	VITROS Immunodiagnostic Products Anti-HBs (total antibody to hepatitis B surface antigen...	Ortho-Clinical Diagnostics, Inc.	LOM	2012-11-01
Z-0716-2013	Class II	Abbott Point of Care i-Stat cTnI cartridge. The i-Stat cardiac troponin I (cTnI) test is...	Abbott Point of Care Canada Limited	MMI	2012-11-01
Z-0474-2013	Class II	Bio-Modular Humeral Head 48mm x 24mm Ti 6AI4V/Ion Implanted (Orthopedic Implant) Product...	Zimmer GmbH	KWT	2012-11-01
Z-0612-2013	Class II	Access Immunoassay System, Access 2 Immunoassay System, Synchron LXi 725 Clinical System...	Siemens Healthcare Diagnostics Inc.	JJE	2012-11-01
Z-0472-2013	Class II	OSS Reamer Sleeve REF132-472662 KNEE REAMER SLEEVE 13.0 thru 20.0 STAINLESS STEEL The...	Zimmer GmbH	HTO	2012-11-01
Z-0471-2013	Class II	OSS Reamer Sleeve REF132-472661 KNEE REAMER SLEEVE 8.0 THRU 12.5 STAINLESS STEEL The OSS...	Zimmer GmbH	HTO	2012-11-01