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 883 of 1190

FDA device recalls, page 883 of 1190
Recall number	Product	Recalling firm	Product code	Initiated
Z-0536-2011	Zimmer, NexGen Complete Knee Solution LPS Flex Gender Femoral Component, Size E Right...	Zimmer GmbH	JWH	2010-09-15
Z-0535-2011	Zimmer, NexGen Complete Knee Solution LPS Flex Gender Femoral Component, Size E Left...	Zimmer GmbH	JWH	2010-09-15
Z-0534-2011	Zimmer, NexGen Complete Knee Solution LPS Flex Gender Femoral Component, Size F Right...	Zimmer GmbH	JWH	2010-09-15
Z-0533-2011	Zimmer, NexGen Complete Knee Solution LPS Flex Gender Femoral Component, Size G Left...	Zimmer GmbH	JWH	2010-09-15
Z-0532-2011	Zimmer, NexGen Complete Knee Solution LPS Femoral Component, Size E Right, sterile, REF...	Zimmer GmbH	JWH	2010-09-15
Z-0531-2011	Zimmer, NexGen Complete Knee Solution LPS Femoral Component, Size F Right, sterile, REF...	Zimmer GmbH	JWH	2010-09-15
Z-0530-2011	Zimmer, NexGen Complete Knee Solution LPS Femoral Component, Size F Left, sterile, REF...	Zimmer GmbH	JWH	2010-09-15
Z-0529-2011	Zimmer, NexGen Complete Knee Solution LPS Femoral Component, Size G Right, sterile, REF...	Zimmer GmbH	JWH	2010-09-15
Z-0528-2011	Zimmer, NexGen Complete Knee Solution LPS Femoral Component, Size G Left, sterile, REF...	Zimmer GmbH	JWH	2010-09-15
Z-0146-2011	Sigma Spectrum VOLUMETRIC INFUSION PUMP, with or without Master Drug Library, Part Number...	Baxter Healthcare Corporation	FRN	2010-09-15
Z-0161-2011	Licox Brain PMO Probe Kit; Ref IP2.P; Multiparameter Monitoring Oxygen + ICP Channel...	Integra LifeSciences Corporation	GWM	2010-09-15
Z-0713-2011	Custom Comprehensive Shoulder Bio-Modular Base, 44 mm Humeral Tray standard, sterile...	Zimmer GmbH	KWS	2010-09-13
Z-0712-2011	Comprehensive Reverse Shoulder Humeral Tray with Locking Ring, 49 mm standard, sterile...	Zimmer GmbH	KWS	2010-09-13
Z-0134-2011	Medtronic Octopus Nuvo Tissue Stabilizer, model TSMICS1. The Octopus Nuvo Tissue...	Medtronic Perfusion Systems	DWS	2010-09-13
Z-0162-2011	IV Catheter - Optiva IV Catheter. This is found in box labeled 'Graft Jacket Xpress...	LifeCell Corp	KGZ	2010-09-13
Z-0629-2011	ARCHITECT iVancomycin Reagent; an in vitro chemiluminescent microparticle immunoassay...	Abbott Medical	DLJ	2010-09-13
Z-2408-2011	XiO Radiation Treatment Planning System, XiO Release 1.0.2 and above. Used to create...	Elekta Limited	muj	2010-09-10
Z-1821-2011	*REF 24k100QTY 124k Arthroscopy Outflow/Suction Tubing SetMADE IN USA**Rx...	Linvatec Corporation	JCY	2010-09-10
Z-1517-2011	Applied Medical's KW/MOH LAP CHOLE KIT; Model Number: K2184 The device is used to close a...	Applied Medical Resources Corp	GCJ	2010-09-10
Z-1516-2011	Applied Medical's LAP CHOLE ; Model Number: K2155 The device is used to close a clip in...	Applied Medical Resources Corp	GCJ	2010-09-10
Z-1515-2011	Applied Medical's LAP CHOLE KIT; Model Number: K2154 The device is used to close a clip...	Applied Medical Resources Corp	GCJ	2010-09-10
Z-1514-2011	Applied Medical's PREMIUM DISPOSABLE LAP CHOLE KIT; Model Number: K2136 The device is...	Applied Medical Resources Corp	GCJ	2010-09-10
Z-1513-2011	Applied Medical's LAP CHOLE KIT ; Model Number: K2114 The device is used to close a clip...	Applied Medical Resources Corp	GCJ	2010-09-10
Z-1512-2011	Applied Medical's LAP CHOLE KIT ; Model Number: K0684 The device is used to close a clip...	Applied Medical Resources Corp	GCJ	2010-09-10
Z-1511-2011	Applied Medical's LAP CHOLE KIT ; Model Number: K0630 The device is used to close a clip...	Applied Medical Resources Corp	GCJ	2010-09-10
Z-1510-2011	Applied Medical's LAP CHOLE KIT - BLADED; Model Number: K0552 The device is used to close...	Applied Medical Resources Corp	GCJ	2010-09-10
Z-1509-2011	Applied Medical's LAP CHOLE KIT - 1A; Model Number: K0522 The device is used to close a...	Applied Medical Resources Corp	GCJ	2010-09-10
Z-1508-2011	Applied Medical's AM CHOLE KIT-TAM1; Model Number: K0509 The device is used to close a...	Applied Medical Resources Corp	GCJ	2010-09-10
Z-1507-2011	Applied Medical's LAP CHOLE KIT ; Model Number: K0492 The device is used to close a clip...	Applied Medical Resources Corp	GCJ	2010-09-10
Z-1506-2011	Applied Medical's LAP CHOLE KIT ; Model Number: K0491 The device is used to close a clip...	Applied Medical Resources Corp	GCJ	2010-09-10
Z-1505-2011	Applied Medical's LAP CHOLE KIT 16 GK; Model Number: GK116 The device is used to close a...	Applied Medical Resources Corp	GCJ	2010-09-10
Z-1504-2011	Applied Medical's LAP CHOLE KIT 9 GK; Model Number: GK109-H The device is used to close a...	Applied Medical Resources Corp	GCJ	2010-09-10
Z-1503-2011	Applied Medical's LAP CHOLE KIT 8 GK; Model Number: GK108 The device is used to close a...	Applied Medical Resources Corp	GCJ	2010-09-10
Z-1502-2011	Applied Medical's LAP CHOLE KIT 7 GK; Model Number: GK107 The device is used to close a...	Applied Medical Resources Corp	GCJ	2010-09-10
Z-1501-2011	Applied Medical's LAP CHOLE KIT 5 GK; Model Number: GK105 The device is used to close a...	Applied Medical Resources Corp	GCJ	2010-09-10
Z-1500-2011	Applied Medical's GELPOINT LAP CHOLE KIT 2; Model Number: CK102 The device is used to...	Applied Medical Resources Corp	GCJ	2010-09-10
Z-1499-2011	Applied Medical's Direct Drive Laparoscopic Clip Applier; Model Number: CA090 The device...	Applied Medical Resources Corp	GCJ	2010-09-10
Z-0829-2011	Vanguard Knee Instruments offset reamer bushing - angled, REF 32-488519, Biomet Bridgend...	Zimmer GmbH	LXH	2010-09-10
Z-0339-2011	RX ACCULINK Carotid Stent System 7-10 X 40mm, Part Number: 1011344-40, Lot Number...	Abbott Vascular	NIM	2010-09-10
Z-0338-2011	RX ACCULINK Carotid Stent System 10 X 20mm, Part Number: 1011342-20, Lot Number...	Abbott Vascular	NIM	2010-09-10
Z-0337-2011	RX ACCULINK Carotid Stent System 9 X 20mm, Part Number: 1011341-20, Lot Number...	Abbott Vascular	NIM	2010-09-10
Z-0576-2011	Zimmer Trabecular Metal Reverse Shoulder System Surgical Technique. Catalog Number...	Zimmer GmbH	KWT	2010-09-10
Z-0575-2011	Zimmer Trabecular Metal Humeral Stem 4-Part Fracture Surgical Technique. Catalog Number...	Zimmer GmbH	KWT	2010-09-10
Z-0574-2011	Zimmer Trabecular Metal Humeral Stem Surgical Technique. Catalog Number: 97-4309-002-00...	Zimmer GmbH	KWT	2010-09-10
Z-0573-2011	TRABECULAR METAL" SHOULDER REAMER CASE used for implantation of the Zimmer Trabecular...	Zimmer GmbH	KWT	2010-09-10
Z-0572-2011	BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION INTRAMEDULLARY REAMER used for...	Zimmer GmbH	KWT	2010-09-10
Z-0571-2011	ZIMMER TRABECULAR METAL" SHOULDER INSTRUMENTATION, DISTAL PILOT used for implantation of...	Zimmer GmbH	KWT	2010-09-10
Z-0570-2011	ZIMMER TRABECULAR METAL SHOULDER INSTRUMENTATION, DISTAL PILOT used for implantation of...	Zimmer GmbH	KWT	2010-09-10
Z-2481-2010	Terumo Advanced Perfusion System 1, Catalog number 801764, 220/240V System 1 base, Terumo...	Terumo Cardiovascular Systems Corporation	DTQ	2010-09-10
Z-2480-2010	Terumo Advanced Perfusion System 1, Catalog number 801763, 100/120V System 1 base, Terumo...	Terumo Cardiovascular Systems Corporation	DTQ	2010-09-10