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 806 of 1190

FDA device recalls, page 806 of 1190
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-1149-2012		Stockert, S5 Roller pump 150, Part 10-80-00, Sorin Group Deutschland GMBH...	LivaNova USA, Inc.	DTQ	2012-02-16
Z-1133-2012		BardPort M.R.I. Implanted Port with Attachable 6 Fr. ChronoFlex Open-Ended Single-Lumen...	Bard Access Systems, Inc.	LJT	2012-02-16
Z-2116-2017	Class III	Pointe Scientific Hitachi AST Reagent R1 : PE plastic bottle w/PP plastic cap. R2: PE...	Horiba Instruments Incorporated	CIT	2012-02-15
Z-1159-2012		Siemens Ysio, AXIOM Luminos dRF, AXIOM Luminos Agile/TF, Uroskop Omnia Solid state x-ray...	Siemens Medical Solutions USA, Inc.	MQB	2012-02-15
Z-1324-2012		Sydney IVF Culture Oil, REF, K- SICO- 50, 50 mL. and K-SICO-200, 200 mL,Store at 2-8 C...	Cook Incorporated	MQL	2012-02-15
Z-1270-2012		MOSAIQ System; customers with Siemens branded linear accelerators with a COHERENCE RT...	Siemens Medical Solutions USA, Inc.	IYE	2012-02-14
Z-1223-2012		Vanguard Knee Instrumentation Tibial Resection Tower Universal with alignment tower...	Biomet U.K., Ltd.	LXH	2012-02-14
Z-1222-2012		Vanguard Knee Instrumentation Distal Cutting Block without Handles, REF 32-487002 LOT...	Biomet U.K., Ltd.	LXH	2012-02-14
Z-2107-2012	Class I	Smiths Medical, Medfusion Syringe Infusion Pump, Model 4000, Software Version V1.0 &...	Abbott Medical	FRN	2012-02-14
Z-1216-2012		Philips EasyDiagnost Eleva DRF, Fluoroscopic x-ray system Software Release 3.0 and...	Philips North America LLC	KPR	2012-02-14
Z-0936-2014	Class II	The Symbionic Leg is an integrated prosthetic leg for transfemoral and knee...	Ossur Americas	ISH	2012-02-12
Z-1123-2012		Coiled 60" Low Pressure Extension Tube 400 PSI Max; packaged in Plastic and Tyvec pouch...	Mallinckrodt, Inc.	DXT	2012-02-10
Z-1122-2012		Mallinckrodt Optistar Elite 60 mL Syringe with Lateral Flow Needle, Liebel-Flarsheim...	Mallinckrodt, Inc.	DXT	2012-02-10
Z-1121-2012		Mallinckrodt Optistar Elite 90" Y-Tubing with Single Check Valve, Liebel-Flarsheim...	Mallinckrodt, Inc.	DXT	2012-02-10
Z-1120-2012		Mallinckrodt Optistar Elite 60" Y-Tubing with Single Check Valve, Liebel-Flarsheim...	Mallinckrodt, Inc.	DXT	2012-02-10
Z-1119-2012		Liebel-Flarsheim Optistar MR 25 mL Syringe w/lateral flow needle, Mallinckrodt...	Mallinckrodt, Inc.	DXT	2012-02-10
Z-1118-2012		Liebel-Flarsheim Optistar MR 60 mL Syringe w/lateral flow needle, Mallinckrodt...	Mallinckrodt, Inc.	DXT	2012-02-10
Z-1201-2012		TDX SP Power Wheelchair, Model #'s: TDXSP-CG, TDXSP-CG-GT, TDXSP-MCG, TDXSP-MCG-GT...	Invacare GmbH	ITI	2012-02-10
Z-2123-2012	Class II	Integra Advansys Medial Lisfranc Plate (MLP), Integra, 311 Enterprise Drive, Plainsboro...	Integra LifeSciences Corporation	HRS	2012-02-09
Z-0501-2013	Class II	Empi STIMC RE Self Adhesive electrodes. For use on TENS, NMES, FES. a DJO brand A...	Medtronic, Inc.	GXY	2012-02-09
Z-0500-2013	Class II	Performa reusable and self-adhering TENS/NMES/FES stimulating electrodes, A cutaneous...	Medtronic, Inc.	GXY	2012-02-09
Z-0499-2013	Class II	Reusable, Self-Adhering TENS/NMES/FES electrodes Single Patient Use Only. An...	Medtronic, Inc.	GXY	2012-02-09
Z-0498-2013	Class II	Reusable, non-sterile, self-adhering electrodes for use with TENS/NMES, . Made in the...	Medtronic, Inc.	GXY	2012-02-09
Z-1279-2012		Codman ICP Skull Bolt Kit, Product Code: 82-6638. Single Use, disposable drill kit for...	Cerenovus, Inc.	GWM	2012-02-09
Z-1230-2012		CARTO 3 Systems, Product Code M-4800-01 The intended use of the CARTO 3 System is...	Biosense Webster Inc	DQK	2012-02-09
Z-1134-2012		Philips IntelliVue Patient Monitors: The monitor is intended to be used for monitoring...	Philips North America LLC	MHX	2012-02-09
Z-2160-2012	Class II	The finger cots are made out of natural rubber. They are disposable products used to...	Afassco Inc	FQM	2012-02-08
Z-1423-2012		Non-sterile wound closure strips, packaged as follows: DeRoyal NS EPISEAL, Wound Closure...	Deroyal Industries, Inc. Lafollette	KGX	2012-02-07
Z-1422-2012		Sterile sterile surgical kits containing Episeal products, packaged as follows: DeRoyal...	Deroyal Industries, Inc. Lafollette	KDD	2012-02-07
Z-1421-2012		Sterile wound closure strips, packaged as follows: DeRoyal EPISEAL, Wound Closure Strips...	Deroyal Industries, Inc. Lafollette	KGX	2012-02-07
Z-1184-2012		Siemens mMLC (ModuLeaf) safety bar and trolley label. Siemens Medical Solutions USA...	Siemens Medical Solutions USA, Inc.	IXI	2012-02-07
Z-1209-2012		Wet PVP-I Vaginal Preoperative Skin Prep Tray containing 1 - 4 oz. bottle Povidone Iodine...	Medtronic, Inc.	HGD	2012-02-07
Z-1208-2012		Wet PVP-I Preoperative Skin Prep Tray containing 1 - 4 oz. bottle Povidone Iodine...	Medtronic, Inc.	OJU	2012-02-07
Z-1207-2012		Wet PVP-I Small Procedure Preoperative Skin Prep Tray containing 1 - 59 mL bottle...	Medtronic, Inc.	OJU	2012-02-07
Z-1143-2012		OSS AVL Poly Tibial Bushing Set OSS AVL Tibial Bushings are designed to hold the...	Zimmer GmbH	LZO	2012-02-07
Z-1093-2012		GE Healthcare, LOGIQ S8 DIAGNOSTIC ULTRASOUND SYSTEM with R1.1.0 Software. Intended for...	GE Healthcare	IYN	2012-02-07
Z-2267-2012	Class II	CaviCide, Part Numbers: 13-1025, 13-1000, 13-1024, MC-1000. Alternate...	Metrex Research	LRJ	2012-02-06
Z-1854-2012	Class II	VerifyNow System, part #85005-6H Product Usage: The VerifyNow P2Y12 assay device is a...	Accumetrics, Inc.	JOZ	2012-02-06
Z-1853-2012	Class II	VerifyNow P2Y12 Assay, Part Number: 85064, All reagent lots. Product Usage: The...	Accumetrics, Inc.	JOZ	2012-02-06
Z-1461-2012		NOCTURNAL ELITE CARE CLINER 6980(STD)/6990(X-LG) products are labeled in part...	Champion Mfg, Inc.	INM	2012-02-06
Z-1460-2012		ELITE CARE CLINER 6940(STD)/6950(X-LG) w/ Swing Arm products are labeled in part...	Champion Mfg, Inc.	INM	2012-02-06
Z-1459-2012		ELITE CARE CLINER 6900 (STD)/6910(X-LG) with Swing-Arm products are labeled in part...	Champion Mfg, Inc.	INM	2012-02-06
Z-1458-2012		CARE CLINER 6550 (STD)/6570 (X-LG) with Drop Arm products are labeled in part: "***CARE...	Champion Mfg, Inc.	INM	2012-02-06
Z-1457-2012		CARE CLINER 6530 (STD)/6540 (X-LG) products are labeled in part: "***CARE CLINER...	Champion Mfg, Inc.	INM	2012-02-06
Z-1185-2012		HAMILTON G5 ventilators with software version V2.0x. Hamilton Medical AG...	Hamilton Medical AG	CBK	2012-02-06
Z-1190-2012		Right Long Tactile Probe, Part #962011S, Medtronic Navigation, Louisville, CO 80027...	Medtronic Navigation, Inc	HAW	2012-02-06
Z-1189-2012		Left Long Tactile Probe, Part #962009S, Medtronic Navigation, Louisville, CO 80027...	Medtronic Navigation, Inc	HAW	2012-02-06
Z-1202-2012		da Vinci S. Surgical System, da Vinci Si and da Vinci Si-e Surgical Systems. Intuitive...	Intuitive Surgical, Inc.	NAY	2012-02-06
Z-1225-2012		Smith & Nephew BIOSURE HA Interference Screw, 7 mm x 25 mm Catalog Number: 72201772. The...	Smith & Nephew, Inc.	HWC	2012-02-06
Z-1069-2012		AngioDynamics SPECIAL ORDER Morpheus Smart PICC CT --- 4F Single Lumen 65cm --- Max CT...	Angiodynamics Worldwide Headquarters	LJS	2012-02-06