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 2026-10-19, the FDA export date. FDA medical device recall database

59,528 records, page 737 of 1191

FDA device recalls, page 737 of 1191
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-0026-2014	Class II	Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the...	Boston Scientific Corporation	LWP	2013-08-29
Z-0025-2014	Class II	Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models...	Boston Scientific Corporation	LWP	2013-08-29
Z-0192-2014	Class II	DePuy Mitek FMS Outflow Tubing with One-Way valve Product Code:284649 Product Usage...	DePuy Mitek, Inc.	HRX	2013-08-29
Z-0191-2014	Class II	DePuy Mitek FMS Intermediary Tubing with One-Way valve Product Code: 281142 Product...	DePuy Mitek, Inc.	HRX	2013-08-29
Z-0180-2014	Class II	CARESTREAM DRX -Mobile Retrofit Kit, Catalog number: 1019397. Made in U.S.A. by...	Eastman Kodak Company	MQB	2013-08-29
Z-0179-2014	Class II	DRX- Revolution, Catalog number: 101937, 1023415 & 1023423. Made in U.S.A. by Carestream...	Eastman Kodak Company	IZL	2013-08-29
Z-0186-2014	Class II	Combiset Blood Line Hemodialysis use Catalog Number: 03-2622-3. Intended for use as the...	Fresenius Medical Care Renal Therapies Group, LLC	ONW	2013-08-29
Z-0185-2014	Class II	Combiset Blood Line with BVM for Hemodialysis use Catalog Number: 03-2965-9. Intended...	Fresenius Medical Care Renal Therapies Group, LLC	ONW	2013-08-29
Z-0184-2014	Class II	2008K@ Home Blood lines Combiset True Flow Series for Hemodialysis use Catalog Number...	Fresenius Medical Care Renal Therapies Group, LLC	ONW	2013-08-29
Z-1845-2014	Class II	Siemens RAD Fluoro Uro System (Ysio, Luminos dRF, and Uroskop Omnia) with software...	Siemens Medical Solutions USA, Inc.	KPR	2013-08-28
Z-0123-2014	Class II	Globus Medical MicroFuse Putty, 2.5cc and 10cc. Product Usage: MicroFuse Bone Void...	Globus Medical, Inc.	MQV	2013-08-28
Z-0372-2014	Class II	* 1) SYMBIQ One-Channel Infuser; * 2) SYMBIQ Two-Channel Infuser; *** E09 batteries...	Abbott Medical	FRN	2013-08-28
Z-0010-2014	Class I	GE Healthcare, Avance, Avance CS2, Aisys, Aespire View, and Engstrom. Intended for...	GE Healthcare	BSZ	2013-08-28
Z-0277-2014	Class II	VerSys Cemented Revision Calcar (CRC) Hip System Femoral Stems VerSys Heritage Hip System...	Zimmer GmbH	JDI	2013-08-28
Z-0129-2014	Class II	Ti-Magna Fx Washer Ti-Versa-FXII Femoral Fixation System S/C Plates The compression...	Zimmer GmbH	NDG	2013-08-28
Z-2206-2013	Class II	C2244.5008 CONELOG Titanbasis CAD/CAM Conelog Titanium Base CAD/CAM Rx only 5.0GH 0.8...	Camlog USA	NHA	2013-08-28
Z-2205-2013	Class II	C2244.4308 CONELOG Titanium Base CC 4.3GH2 0.8 inkl HS Product Usage: Endosseous dental...	Camlog USA	NHA	2013-08-28
Z-2204-2013	Class II	C2244.3820;, CONELOG Titanium Base CC 3.8GH2.0 inkl HS Product Usage: Endosseous dental...	Camlog USA	NHA	2013-08-28
Z-2203-2013	Class II	C2244.3808, CONELOG Titanium Base CC 3.8GH0.8 inkl HS Product Usage: Endosseous dental...	Camlog USA	NHA	2013-08-28
Z-2193-2013	Class II	*** 1) Cat. 4341B; Qty. 10; Thoracentesis Tray; With Catheter; Sterile; CareFusion; 1500...	Medtronic, Inc.	GCB	2013-08-28
Z-0274-2014	Class II	S-LIFT Extension Shims Extension shims are manufactured from grade 5 titanium and are...	SPINEFRONTIER, Inc. dba LESspine Innovations	LXH	2013-08-28
Z-0572-2014	Class II	Captia Syphilis-G Test Kit Product Usage: This is an enzyme immunoassay for the...	Trinity Biotech USA	LIP	2013-08-27
Z-0868-2014	Class II	T3F, Free T3 Assay, REF/Catalog Number L2KF32 (200 tests), Siemens Material Number (SMN)...	Siemens Healthcare Diagnostics Inc.	CDP	2013-08-27
Z-0867-2014	Class II	T3F, Free T3 Assay, REF/Catalog Number LKF31, Siemens Material Number (SMN) 10381626; an...	Siemens Healthcare Diagnostics Inc.	CDP	2013-08-27
Z-0449-2014	Class II	GENESIS(R) II, MOBILE BEARING ARTICULAR INSERT RIGHT, SIZE 5, 9 MM QTY: (1), REF...	Smith & Nephew, Inc.	JWH	2013-08-27
Z-0448-2014	Class II	GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 5-6, 11 MM QTY: (1), REF 71421516...	Smith & Nephew, Inc.	JWH	2013-08-27
Z-0447-2014	Class II	GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 5-6, 9 MM QTY: (1), REF 71421515...	Smith & Nephew, Inc.	JWH	2013-08-27
Z-0446-2014	Class II	GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 3-4, 9 MM QTY: (1), REF 71421508...	Smith & Nephew, Inc.	JWH	2013-08-27
Z-0445-2014	Class II	GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 3-4, 13 MM QTY: (1), REF 71420820...	Smith & Nephew, Inc.	JWH	2013-08-27
Z-0444-2014	Class II	GENESIS(R) II, POSTERIOR STABILIZED ARTICULAR INSERT, SIZE 1-2, 13 MM QTY: (1), REF...	Smith & Nephew, Inc.	JWH	2013-08-27
Z-0006-2014	Class I	H&H Emergency Cricothyrotomy Kit (Part No. HHECT01/ HHECTK01, NSN 6515-01-573-0692)...	H & H Associates	BSK	2013-08-27
Z-0503-2015	Class II	Crocodile (size 3) are two-armed, wheeled walking aids, used by children with...	R82 Inc.	IOR	2013-08-26
Z-0574-2015	Class II	Zimmer Title 2 Bone Screw Remover Instrument, Part Number ET1093-01 Rx Only...	Zimmer GmbH	KWP	2013-08-26
Z-1215-2014	Class II	Dental Abutment labeled in part: "4555 Riverside Drive Palm Beach Gardens, FL 33410 USA...	ZimVie US Corp LLC	NHA	2013-08-26
Z-0135-2014	Class II	Edwards Lifesciences Dispersion Aortic Perfusion Cannula with Duraflo Coating, Sterile...	Edwards Lifesciences LLC	DWF	2013-08-26
Z-0134-2014	Class II	Edwards Lifesciences Fem-Flex Femoral Arterial Cannula with Duraflo Coating, DIITFA02225...	Edwards Lifesciences LLC	DWF	2013-08-26
Z-0136-2014	Class II	Bayer brand A1CNow+ MULTI-TEST A1C SYSTEM TEST KITS (PART NUMBER 3021/08842610)...	Medrad, Inc.	LCP	2013-08-26
Z-0748-2014	Class II	Merge Mammo is a multi-modality, vendor-neutral digital mammography workstation that...	GE Healthcare	LLZ	2013-08-26
Z-2284-2013	Class II	Universal Titanium Prosthesis, Round Head, with Flex H/A titanium shoe. The ear...	Medtronic Xomed, Inc.	ETA	2013-08-23
Z-2274-2013	Class II	BD Epilor Syringe BD Franklin Lakes, NJ 07417 BD EDC Laagstraat 57, B-9140...	Becton Dickinson & Co	CAZ	2013-08-23
Z-0983-2015	Class II	Timberline Anchored Lateral Fixed Retractable Sleeve Model No. 8630-0205. Timberline...	Highridge Medical, LLC	OVD	2013-08-22
Z-0978-2015	Class II	Timberline Anchored Lateral Variable Retractable Sleeve LITPCR8600-2101-07, Model No...	Highridge Medical, LLC	OVD	2013-08-22
Z-0982-2015	Class II	Anchored Lateral Retractable Drill, Timberline IPF IFU IFU8621-0113, Model 8630-0102...	Highridge Medical, LLC	OVD	2013-08-22
Z-0137-2014	Class II	Surgicutt fully automated incision making device for bleeding time determination. ITC 8...	Accriva Diagnostics, Inc.	JCA	2013-08-22
Z-0359-2014	Class II	BIOMET Spine, 5.5 TI 5.5x50mm Translation Screw Polaris 5.5 TI Spinal System. Rx Only...	Ebi, LLC	HWC	2013-08-22
Z-2165-2013	Class II	Baxa Vial Adapter, 14mm - Luer Lock, Order No. REF: 90, Quantity: 50 each, Single Use...	Baxter Corporation Englewood	LHI	2013-08-22
Z-0532-2014	Class II	Spectre Wireless Footswitch/Handswitch system Model 98/99, Model FDS, Model FDB. The...	Trans American Medical, Inc.	IZL	2013-08-22
Z-0004-2014	Class II	SHOPKO Waterproof Adhesive Pads Antibacterial. Used for covering minor cuts, scrapes and...	Aso LLC	MXE	2013-08-21
Z-2129-2013	Class I	Microscan rapID/S panels NC3.33 Sold in Japan only. Product Usage: MicroScan Synergies...	Siemens Healthcare Diagnostics Inc.	LON	2013-08-21
Z-2128-2013	Class I	Microscan rapID/S panels NC3.12 Sold in Japan only. Product Usage: MicroScan Synergies...	Siemens Healthcare Diagnostics Inc.	LON	2013-08-21