Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR

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

59,460 records, page 1029 of 1190
FDA device recalls, page 1029 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1277-2008Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model...Edwards Lifesciences LLCFGE
Z-1276-2008Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model...Edwards Lifesciences LLCFGE
Z-1275-2008Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model...Edwards Lifesciences LLCFGE
Z-1274-2008Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model...Edwards Lifesciences LLCFGE
Z-1273-2008Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model...Edwards Lifesciences LLCFGE
Z-1272-2008Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model...Edwards Lifesciences LLCFGE
Z-1271-2008Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model...Edwards Lifesciences LLCFGE
Z-1270-2008Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model...Edwards Lifesciences LLCFGE
Z-1269-2008Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model...Edwards Lifesciences LLCFGE
Z-1268-2008Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model...Edwards Lifesciences LLCFGE
Z-1267-2008Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model...Edwards Lifesciences LLCFGE
Z-1266-2008Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model...Edwards Lifesciences LLCFGE
Z-1265-2008Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model...Edwards Lifesciences LLCFGE
Z-1264-2008Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model...Edwards Lifesciences LLCFGE
Z-1263-2008Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model...Edwards Lifesciences LLCFGE
Z-1262-2008Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model...Edwards Lifesciences LLCFGE
Z-1261-2008Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model...Edwards Lifesciences LLCFGE
Z-1260-2008Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model...Edwards Lifesciences LLCFGE
Z-1259-2008Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model...Edwards Lifesciences LLCFGE
Z-1258-2008Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model...Edwards Lifesciences LLCFGE
Z-1257-2008Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model...Edwards Lifesciences LLCFGE
Z-1256-2008Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model...Edwards Lifesciences LLCFGE
Z-1255-2008Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model...Edwards Lifesciences LLCFGE
Z-1254-2008Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model...Edwards Lifesciences LLCFGE
Z-1253-2008Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model...Edwards Lifesciences LLCFGE
Z-1252-2008Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model...Edwards Lifesciences LLCFGE
Z-1251-2008Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model...Edwards Lifesciences LLCFGE
Z-1250-2008Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model...Edwards Lifesciences LLCFGE
Z-1249-2008Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model...Edwards Lifesciences LLCFGE
Z-1248-2008Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model...Edwards Lifesciences LLCFGE
Z-1247-2008Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model...Edwards Lifesciences LLCFGE
Z-1246-2008Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model...Edwards Lifesciences LLCFGE
Z-1352-2008Triage Micro ClostrIdium difficile (C.difficile) Panel, Catalog No: 96000, BIOSITE...Alere San Diego, Inc.MCB
Z-0576-2008Roche COBAS 6000 Clinical Chemistry analyzer; Catalog Number: 04745914001, Roche...Roche Diagnostics GmbHJJY
Z-0738-2008Optiflux 180NR Advanced Fresenius Polysulfone, Catalog No.: 0500318E, Fresenius Medical...Fresenius Medical Care Renal Therapies Group, LLCKDI
Z-0875-2008Dri-Sate Glacial Acidic Acid (liquid component of Dri-Sate Dry Acid Concentrate DR-240)...Rockwell MedicalKPO
Z-0874-2008Glacial Acidic Acid (liquid component of Dri-Sate Dry Acid Concentrate DR-215); 1 quart...Rockwell MedicalKPO
Z-0873-2008RenalPure Liquid Acid Concentrate R-259; One Gallon (3.78 liters); manufactured by...Rockwell MedicalKPO
Z-0872-2008RenalPure Liquid Acid Concentrate R-235; One Gallon (3.78 liters); manufactured by...Rockwell MedicalKPO
Z-0871-2008RenalPure Liquid Acid Concentrate R-006; One Gallon (3.78 liters); manufactured by...Rockwell MedicalKPO
Z-0517-2008Medtronic Bravo pH Capsule with Delivery System, Stomach pH electrode, Product Numbers...Medtronic NeuromodulationFFT
Z-0688-2008Roche LIPC Lipase Colorimetric Reagent; Catalog Number: 03029590322. Roche Diagnostics...Roche Diagnostics GmbHJFJ
Z-1049-2008Siemens Magnetom Sonata syngo, Model Number: 7104719, Siemens Medical Solutions USA...Siemens Medical Solutions USA, Inc.LNH
Z-1048-2008Siemens Magentom Symphony syngo Upgrade, Model Number: 7106557, Siemens Medical...Siemens Medical Solutions USA, Inc.LNH
Z-1047-2008Siemens Magnetom Symphony syngo, Model Number: 7104594, Siemens Medical Solutions USA...Siemens Medical Solutions USA, Inc.LNH
Z-1046-2008Siemens Magnetom Sonata syngo, Model Number: 7106425, Siemens Medical Solutions USA...Siemens Medical Solutions USA, Inc.LNH
Z-1045-2008Siemens Magentom Symphony, Model Number: 4760265, Siemens Medical Solutions USA, Malvern...Siemens Medical Solutions USA, Inc.LNH
Z-1044-2008Siemens Magnetom Harmony sygno. Model Number: 7104693, Siemens Medical Solutions USA...Siemens Medical Solutions USA, Inc.LNH
Z-1043-2008Siemens Magnetom Harmony syngo. Model Number: 7106714, Siemens Medical Solutions USA...Siemens Medical Solutions USA, Inc.LNH
Z-1042-2008Siemens Magnetom Harmony Mobile MRI System. Model Number: 4759309, Siemens Medical...Siemens Medical Solutions USA, Inc.LNH