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 875 of 1190

FDA device recalls, page 875 of 1190
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-0389-2011		Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084504300, Manufactured by Sorin...	LivaNova USA, Inc.	DWF	2010-10-07
Z-0388-2011		Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084503500, Manufactured by Sorin...	LivaNova USA, Inc.	DWF	2010-10-07
Z-0387-2011		Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084503400, Manufactured by Sorin...	LivaNova USA, Inc.	DWF	2010-10-07
Z-0386-2011		Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084503000, Manufactured by Sorin...	LivaNova USA, Inc.	DWF	2010-10-07
Z-0385-2011		Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084502100, Manufactured by Sorin...	LivaNova USA, Inc.	DWF	2010-10-07
Z-0384-2011		Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084502000, Manufactured by Sorin...	LivaNova USA, Inc.	DWF	2010-10-07
Z-0383-2011		Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084501200, Manufactured by Sorin...	LivaNova USA, Inc.	DWF	2010-10-07
Z-0382-2011		Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084501001, Manufactured by Sorin...	LivaNova USA, Inc.	DWF	2010-10-07
Z-0381-2011		Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084500900, Manufactured by Sorin...	LivaNova USA, Inc.	DWF	2010-10-07
Z-0380-2011		Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084500800, Manufactured by Sorin...	LivaNova USA, Inc.	DWF	2010-10-07
Z-0379-2011		Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084500700, Manufactured by Sorin...	LivaNova USA, Inc.	DWF	2010-10-07
Z-0378-2011		Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084500600, Manufactured by Sorin...	LivaNova USA, Inc.	DWF	2010-10-07
Z-0377-2011		Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084500501, Manufactured by Sorin...	LivaNova USA, Inc.	DWF	2010-10-07
Z-0376-2011		Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084500500, Manufactured by Sorin...	LivaNova USA, Inc.	DWF	2010-10-07
Z-0375-2011		Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084500300, Manufactured by Sorin...	LivaNova USA, Inc.	DWF	2010-10-07
Z-0374-2011		Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084500201, Manufactured by Sorin...	LivaNova USA, Inc.	DWF	2010-10-07
Z-0373-2011		Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 082500600, Manufactured by Sorin...	LivaNova USA, Inc.	DWF	2010-10-07
Z-0372-2011		Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 082500500, Manufactured by Sorin...	LivaNova USA, Inc.	DWF	2010-10-07
Z-0371-2011		Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 082500400, Manufactured by Sorin...	LivaNova USA, Inc.	DWF	2010-10-07
Z-0370-2011		Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 082500200, Manufactured by Sorin...	LivaNova USA, Inc.	DWF	2010-10-07
Z-0463-2011		3M ESPE Stainless Steel Primary Molar Crowns, Made in USA by 3M ESPE Dental Products, St...	3M Company	ELZ	2010-10-06
Z-1519-2011		Pacific Hemostasis Thromboplastin-DS, catalog #100354, packaged in 4 mL lypholyzed...	Fisher Diagnostics	GJS	2010-10-06
Z-0400-2011		i-STAT ACT Kaolin Cartridges in vitro diagnostic test which uses fresh whole blood to...	Abbott Medical	JBP	2010-10-06
Z-0399-2011		i-STAT ACT Celite Cartridges in vitro diagnostic test used to monitor moderate and...	Abbott Medical	JBP	2010-10-06
Z-0490-2011		AdvanDx E. coli/P. aeruginosa PNA FISH Culture Identification Kit for the diagnosis of E...	Advandx, Inc.	JSS	2010-10-06
Z-0443-2011		Cholestech LDX Calibration Verification, Levels 1-4, Catalog Number 11-255. To be used...	Alere San Diego, Inc.	JJY	2010-10-06
Z-0442-2011		Cholestech LDX Lipid Controls, Level 1 & 2, 3 vial set, Catalog Number 10-983. Assayed...	Alere San Diego, Inc.	JJY	2010-10-06
Z-0441-2011		Cholestech LDX Lipid Controls, Level 1 & 2, 1 vial set, Catalog Number 10-982. Assayed...	Alere San Diego, Inc.	JJY	2010-10-06
Z-0440-2011		Cholestech LDX Multi-Analyte Controls, Level 1 & 2, 3 vial set, Catalog Number...	Alere San Diego, Inc.	JJY	2010-10-06
Z-0439-2011		Cholestech LDX Multi-Analyte Controls, Level 1 & 2, 1 vial set, Catalog Number...	Alere San Diego, Inc.	JJY	2010-10-06
Z-1937-2011		SYNCHRON LxI 725 Access Clinical Systems, Part Number: 386200. An in vitro diagnostic...	Siemens Healthcare Diagnostics Inc.	JJE	2010-10-05
Z-1936-2011		UniCel DxC 600i Access Immunoassay Systems, Part Number A25656. An in vitro diagnostic...	Siemens Healthcare Diagnostics Inc.	JJE	2010-10-05
Z-1935-2011		Access Immunoassay Systems, Part Number 81600N & 81600N. An in vitro diagnostic device...	Siemens Healthcare Diagnostics Inc.	JJE	2010-10-05
Z-1934-2011		Liquid Waste Bottle To store waste material from completed assays.	Siemens Healthcare Diagnostics Inc.	JJE	2010-10-05
Z-0884-2011		CARTO 3 System Interface Cable, 34-pin to 10-pin, Red, 10' - Part Number: D-1286-18...	Biosense Webster Inc	DSA	2010-10-05
Z-0816-2011		BD Vacutainer Push Button collection Set; Non-Pyrogenic, Sterile, Rx only; 23 G x 3/4 x...	Becton Dickinson & Co	FMI	2010-10-05
Z-0363-2011		GE Healthcare Transport Pro Monitor with the CARESCAPE" Patient Data Module.	GE Healthcare	MHX	2010-10-05
Z-2272-2012	Class II	Sunquest Laboratory LabAccess Results Workstation (LARS)	CliniSys, Inc	JQP	2010-10-05
Z-1218-2011		Spectrum Central Venous Tray Minocycline/Rifampin Impregnated Triple Lumen Polyurethane...	Cook Incorporated	FOZ	2010-10-04
Z-1217-2011		Spectrum Central Venous Tray Minocycline/Rifampin Impregnated Triple Lumen Polyurethane...	Cook Incorporated	FOZ	2010-10-04
Z-1216-2011		Spectrum Central Venous Tray Minocycline/Rifampin Impregnated Triple Lumen Polyurethane...	Cook Incorporated	FOZ	2010-10-04
Z-1215-2011		Spectrum Central Venous Tray Minocycline/Rifampin Impregnated Triple Lumen Polyurethane...	Cook Incorporated	FOZ	2010-10-04
Z-1214-2011		Spectrum Central Venous Tray Minocycline/Rifampin Impregnated Triple Lumen Polyurethane...	Cook Incorporated	FOZ	2010-10-04
Z-1213-2011		Spectrum Central Venous Catheter Tray Minocycline/Rifampin Impregnated 5 Lumen...	Cook Incorporated	FOZ	2010-10-04
Z-1212-2011		Spectrum Central Venous Catheter Tray Minocycline/Rifampin Impregnated 5 Lumen...	Cook Incorporated	FOZ	2010-10-04
Z-1211-2011		Spectrum Central Venous Catheter Tray Minocycline/Rifampin Impregnated 5 Lumen...	Cook Incorporated	FOZ	2010-10-04
Z-1210-2011		Spectrum Central Venous Catheter Tray Minocycline/Rifampin Impregnated 5 Lumen...	Cook Incorporated	FOZ	2010-10-04
Z-1209-2011		Spectrum Central Venous Catheter Tray Minocycline/Rifampin Impregnated 5 Lumen...	Cook Incorporated	FOZ	2010-10-04
Z-1208-2011		Spectrum Central Venous Catheter Tray, Minocycline/Rifampin Antibiotic Impregnated, 5...	Cook Incorporated	FOZ	2010-10-04
Z-1207-2011		Central Venous Catheter Tray Five Lumen Polyurethane, 10.0 Fr/ 20cm...	Cook Incorporated	FOZ	2010-10-04