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 793 of 1190

FDA device recalls, page 793 of 1190
Recall number	Class	Product	Recalling firm	Product code	Initiated
Z-1857-2012	Class II	Hartmann Econolux Ref 416 105 Sterile Gauze sponge 4"x4" 12-ply 24 boxes/case 1200...	Hartmann USA, Inc	NAB	2012-05-14
Z-0007-2013	Class II	BriteField illuminated Suction Device; Model numbers 8Fr, 10Fr and 12Fr, Kit (included...	Invuity, Inc.	JOL	2012-05-12
Z-1895-2012	Class II	Bigliani/Flatow The Complete Shoulder Solution Trabecular Metal Glenoid Instrument Drill...	Zimmer GmbH	KWT	2012-05-12
Z-1581-2015	Class II	ACUSON SC2000 volume imaging ultrasound systems at software versions VA16C, VA16D and...	Siemens Medical Solutions USA, Inc.	IYO	2012-05-11
Z-2198-2012	Class II	Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model TS057HF7. For use in...	Edwards Lifesciences LLC	DYG	2012-05-11
Z-2197-2012	Class II	Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 151HF7. For use in...	Edwards Lifesciences LLC	DYG	2012-05-11
Z-2196-2012	Class II	Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 151F7. For use in...	Edwards Lifesciences LLC	DYG	2012-05-11
Z-2195-2012	Class II	Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 141HF7P. For use in...	Edwards Lifesciences LLC	DYG	2012-05-11
Z-2194-2012	Class II	Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 141HF7J. For use in...	Edwards Lifesciences LLC	DQO	2012-05-11
Z-2193-2012	Class II	Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 141F7. For use in...	Edwards Lifesciences LLC	DQO	2012-05-11
Z-2192-2012	Class II	Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HVF7P. For use in...	Edwards Lifesciences LLC	DYG	2012-05-11
Z-2191-2012	Class II	Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HF7P. For use in...	Edwards Lifesciences LLC	DYG	2012-05-11
Z-2190-2012	Class II	Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HF7J. For use in...	Edwards Lifesciences LLC	DYG	2012-05-11
Z-2189-2012	Class II	Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131F7P. For use in...	Edwards Lifesciences LLC	DYG	2012-05-11
Z-2188-2012	Class II	Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131F7J. For use in...	Edwards Lifesciences LLC	DYG	2012-05-11
Z-1808-2012	Class II	Churchill Medical Systems, Inc. A VYGON COMPANY PICC INSERTION TRAY Prefilled syringes...	Vygon U.S.A.	NZW	2012-05-11
Z-1807-2012	Class II	Churchill Medical Systems, Inc. DRESSING CHANGE KIT Prefilled syringes included in the...	Vygon U.S.A.	NZW	2012-05-11
Z-1806-2012	Class II	Churchill Medical Systems, Inc. VAD ACCESS TRAY Kit Prefilled syringes included in the...	Vygon U.S.A.	NZW	2012-05-11
Z-1805-2012	Class II	Churchill Medical Systems, Inc. VAD ACCESS TRAY Kit Prefilled syringes included in the...	Vygon U.S.A.	NZW	2012-05-11
Z-1804-2012	Class II	Churchill Medical Systems, Inc. A VYGON Company PICC INSERTION TRAY Kit Prefilled...	Vygon U.S.A.	NZW	2012-05-11
Z-1803-2012	Class II	Churchill Medical Systems, Inc. PORT-A-CATH Tray Kit Prefilled syringes included in the...	Vygon U.S.A.	NZW	2012-05-11
Z-1802-2012	Class II	Churchill Medical Systems, Inc. A VYGON Company PICC LINE TRAY Kit Prefilled syringes...	Vygon U.S.A.	NZW	2012-05-11
Z-1801-2012	Class II	Vygon VY(TM)Flush Heparin Lock Flush Syringes, 100 Units per mL, 5mL in a 10mL Flush...	Vygon U.S.A.	NZW	2012-05-11
Z-1800-2012	Class II	Vygon VY(TM)Flush Heparin Lock Flush Syringes, 100 Units per mL, 3mL in a 10mL Flush...	Vygon U.S.A.	NZW	2012-05-11
Z-1799-2012	Class II	Vygon VY(TM)Flush Heparin Lock Flush Syringes, 10 Units per mL, 5mL in a 10mL Flush...	Vygon U.S.A.	NZW	2012-05-11
Z-1798-2012	Class II	Vygon VY(TM)Flush Heparin Lock Flush Syringes, 10 Units per mL, 3mL in a 10mL Flush...	Vygon U.S.A.	NZW	2012-05-11
Z-1797-2012	Class II	Vygon VY(TM)Flush Heparin Lock Flush Syringes, 1 Unit per mL, 3mL in a 10mL Flush...	Vygon U.S.A.	NZW	2012-05-11
Z-1831-2012	Class II	The product is Pathfinder SL, version 1.6.0.3057 software used with the Spacelabs...	GE Healthcare	DQK	2012-05-11
Z-1821-2012	Class II	Philips Easy Diagnost Product Usage: Stationary Fluoroscopic system	Philips North America LLC	IXR	2012-05-11
Z-2089-2014	Class II	Perouse Flamingo, Model 0218TA and 0218TB intended for use during cardiovascular...	Perouse Medical	MAV	2012-05-10
Z-1625-2012		50 Portal Vein Cannula REF 61.110.10.030 Size: Fr 10 Length: 12 Inches LL Connector LOT...	Meddev USA, Inc.	KDH	2012-05-10
Z-1957-2013	Class II	Invue Solid Driver, Tipped, AO. Part Number: 11-70083. Allows the user to retain the...	SPINEFRONTIER, Inc. dba LESspine Innovations	HXX	2012-05-09
Z-0082-2013	Class II	Columbus 4-IN-1 Femoral Cutting Guide M3 Instrument (NQ083R)	Aesculap Inc	LXH	2012-05-09
Z-2324-2012	Class II	Brand name: RayStation. Generic name: Treatment Planning System. Software version and...	RaySearch Laboratories AB (publ)	MUJ	2012-05-09
Z-1848-2012	Class II	Covidien ROTICULATOR 30-V3 Single Use Stapler REF# 017619 The RETICULA TOR TM Single...	Medtronic, Inc.	GDW	2012-05-09
Z-1847-2012	Class II	Covidien ROTICULATOR 30-4.8 Single Use Stapler REF# 017617 The RETICULA TOR TM Single...	Medtronic, Inc.	GDW	2012-05-09
Z-1846-2012	Class II	Covidien ROTICULATOR 30-3.5 Single Use Stapler REF# 017615 The RETICULA TOR TM Single...	Medtronic, Inc.	GDW	2012-05-09
Z-1845-2012	Class II	Covidien ROTICULATOR 55-4.8 Single Use Stapler REF# 017614 The RETICULA TOR TM Single...	Medtronic, Inc.	GDW	2012-05-09
Z-1844-2012	Class II	Covidien ROTICULATOR 55-3.5 Single Use Stapler REF# 017612 The RETICULA TOR TM Single...	Medtronic, Inc.	GDW	2012-05-09
Z-0447-2013	Class I	The product has the Catalogue/Part number 60010. Olympic Cool-Cap System is a selective...	Natus Medical Incorporated	MXM	2012-05-09
Z-1842-2012	Class II	CPB CATHETER KIT- DR.VAN TRIGHT. The Sarns High Flow Aortic Arch Cannula is indicated...	Terumo Cardiovascular Systems Corporation	DWF	2012-05-09
Z-1841-2012	Class II	CUSTOM CPB CATHETER KIT-DR. The Sarns High Flow Aortic Arch Cannula is indicated for use...	Terumo Cardiovascular Systems Corporation	DWF	2012-05-09
Z-1840-2012	Class II	SPECIALTYCARE - HUDGENS. The Sarns High Flow Aortic Arch Cannula is indicated for use in...	Terumo Cardiovascular Systems Corporation	DWF	2012-05-09
Z-1839-2012	Class II	24FR FLEX ART CANN NON STERILE. The Sarns High Flow Aortic Arch Cannula is indicated...	Terumo Cardiovascular Systems Corporation	DWF	2012-05-09
Z-1838-2012	Class II	SARNS FLEXIBLE ARTERIAL CANNULA: 8.0 MM (24 FR) 00 WITH 3/8" CONNECTOR, CM MARKING, 10"...	Terumo Cardiovascular Systems Corporation	DWF	2012-05-09
Z-1837-2012	Class II	SARNS FLEXIBLE ARTERIAL CANNULA: 8.0 MM (24 FR) WITH 3/8" CONNECTOR,SUTURE RING, 9.5" (24...	Terumo Cardiovascular Systems Corporation	DWF	2012-05-09
Z-1836-2012	Class II	SARNS FLEXIBLE ARTERIAL CANNULA: 7.3 MM (22 FR) 00 WITH 3/8" CONNECTOR,SUTURE RING, 9.5"...	Terumo Cardiovascular Systems Corporation	DWF	2012-05-09
Z-1835-2012	Class II	SARNS FLEXIBLE ARTERIAL CANNULA: 6.7 MM (20 FR) 00 WITH 3/8" CONNECTOR,SUTURE RING, 9.5"...	Terumo Cardiovascular Systems Corporation	DWF	2012-05-09
Z-1834-2012	Class II	SARNS HIGH-FLOW AORTIC ARCH CANNULA: 6.5 MM (20 FR) 00 WITH 3/8" CONNECTOR, 11" (28 CM)...	Terumo Cardiovascular Systems Corporation	DWF	2012-05-09
Z-1833-2012	Class II	SARNS HIGH-FLOW AORTIC ARCH CANNULA: 6.5 MM (20 FR) 00 WITH 3/8" CONNECTOR, 11" (28 CM)...	Terumo Cardiovascular Systems Corporation	DWF	2012-05-09