510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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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 , the FDA export date. FDA medical device recall database

59,476 records, page 989 of 1190
FDA device recalls, page 989 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-0073-2009Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards...Bard Peripheral Vascular IncFGE
Z-0072-2009Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards...Bard Peripheral Vascular IncFGE
Z-0071-2009Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards...Bard Peripheral Vascular IncFGE
Z-0070-2009Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards...Bard Peripheral Vascular IncFGE
Z-0069-2009Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards...Bard Peripheral Vascular IncFGE
Z-0068-2009Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards...Bard Peripheral Vascular IncFGE
Z-0067-2009Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards...Bard Peripheral Vascular IncFGE
Z-0066-2009Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards...Bard Peripheral Vascular IncFGE
Z-0065-2009Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards...Bard Peripheral Vascular IncFGE
Z-0064-2009Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards...Bard Peripheral Vascular IncFGE
Z-0063-2009Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards...Bard Peripheral Vascular IncFGE
Z-0062-2009Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards...Bard Peripheral Vascular IncFGE
Z-0061-2009Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards...Bard Peripheral Vascular IncFGE
Z-0060-2009Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards...Bard Peripheral Vascular IncFGE
Z-0059-2009Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards...Bard Peripheral Vascular IncFGE
Z-0058-2009Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards...Bard Peripheral Vascular IncFGE
Z-0057-2009Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards...Bard Peripheral Vascular IncFGE
Z-0056-2009Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards...Bard Peripheral Vascular IncFGE
Z-0055-2009Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards...Bard Peripheral Vascular IncFGE
Z-0054-2009Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards...Bard Peripheral Vascular IncFGE
Z-0053-2009Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards...Bard Peripheral Vascular IncFGE
Z-0052-2009Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards...Bard Peripheral Vascular IncFGE
Z-0051-2009Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards...Bard Peripheral Vascular IncFGE
Z-0050-2009Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards...Bard Peripheral Vascular IncFGE
Z-0049-2009Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards...Bard Peripheral Vascular IncFGE
Z-0048-2009Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards...Bard Peripheral Vascular IncFGE
Z-0047-2009Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards...Bard Peripheral Vascular IncFGE
Z-0046-2009Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards...Bard Peripheral Vascular IncFGE
Z-0045-2009Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards...Bard Peripheral Vascular IncFGE
Z-0044-2009Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards...Bard Peripheral Vascular IncFGE
Z-0043-2009Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards...Bard Peripheral Vascular IncFGE
Z-0042-2009Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards...Bard Peripheral Vascular IncFGE
Z-0041-2009Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards...Bard Peripheral Vascular IncFGE
Z-0040-2009Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards...Bard Peripheral Vascular IncFGE
Z-0039-2009Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards...Bard Peripheral Vascular IncFGE
Z-0038-2009Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards...Bard Peripheral Vascular IncFGE
Z-0037-2009Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards...Bard Peripheral Vascular IncFGE
Z-0036-2009Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards...Bard Peripheral Vascular IncFGE
Z-0035-2009Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards...Bard Peripheral Vascular IncFGE
Z-0118-2009iSite PACS (Picture Archiving and Communication System), software versions 3.6.28.x and...Philips North America LLCLLZ
Z-0209-2013Class IISechrist Monoplace Hyperbaric Chamber with Electronic Control Module Model 3600E/ER The...Sechrist Industries IncCBF
Z-0208-2013Class IISechrist Monoplace Hyperbaric Chamber with Electronic Control Module Model 3300E/ER The...Sechrist Industries IncCBF
Z-2341-2008LIFEPAK CR Plus Automated External Defibrillator. Device is primarily deployed in Public...Physio Control, Inc.MJK
Z-0020-2009GE Datex-Ohmeda Aisys, Datex-Ohmeda, Inc., a General Electric Company going to market as...GE HealthcareBSZ
Z-1004-2010VZV IgM ELISA 96 Well Kit, Catalog Number: VZ082M The products in question are all...Calbiotech IncGQX
Z-1003-2010VZV IgG ELISA 96 Well Kit, Catalog Number: VZ081G The products in question are all...Calbiotech IncLFY
Z-1002-2012Toxoplasma IgM ELISA 96 Well Kit, Catalog Number: TX055M The products in question are...Calbiotech IncLGD
Z-1001-2010Measles IgM ELISA 96 Well Kit, Catalog Number: MS019M The products in question are all...Calbiotech IncLJB
Z-1000-2010Measles IgG ELISA 96 Well Kit, Catalog Number: MS018G The products in question are all...Calbiotech IncLJB
Z-0999-2010Mumps IgM ELISA 96 Well Kit, Catalog Number: MP060G The products in question are all...Calbiotech IncLJY