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 925 of 1190
FDA device recalls, page 925 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1855-2011Stanley Bed-Check 30-Day IT Chair Sensormat, With 4 Ft. Cord, Model 73000, 10 mats per...Securitas Healthcare LLCKMI
Z-0630-2010Sorin / Clearglide Precision Bipolar, REF PBD01, Sterile R, Manufactured for: Sorin Group...LivaNova USA, Inc.GEI
Z-0629-2010Sorin / Clearglide EVH Long View with Scissor, REF KTV23, Sterile R, Manufactured for...LivaNova USA, Inc.GEI
Z-0628-2010Sorin / Clearglide EVH Long View, REF KTV22, Sterile R, Manufactured for: Sorin Group...LivaNova USA, Inc.GEI
Z-0627-2010Sorin / Clearglide EVH Low Profile with Scissor, REF KTV18, Sterile R, Manufactured for...LivaNova USA, Inc.GEI
Z-0626-2010Sorin / Clearglide EVH Small with Scissor, REF KTV17, Sterile R, Manufactured for: Sorin...LivaNova USA, Inc.GEI
Z-0625-2010Sorin / Clearglide EVH Low Profile, REF KTV16, Sterile R, Manufactured for: Sorin Group...LivaNova USA, Inc.GEI
Z-0624-2010Sorin / Clearglide EVH Small, REF KTV15, Sterile R, Manufactured for: Sorin Group USA...LivaNova USA, Inc.GEI
Z-0594-2010Powerlink System with IntuiTrak Delivery System (Endovascular Graft): Model Number...Endologix LLCOAD
Z-0593-2010Powerlink System with IntuiTrak Delivery System (Endovascular Graft): Model Number...Endologix LLCOAD
Z-0585-2010Oxygen Sensor #5804, Distributed by: Teleflex Medical, Research Triangle Park, NC 27709Teleflex MedicalCCL
Z-1044-2010Millipore Millex Syringe Filter Unit, 33 mm Durapore PVDF 0.22um, Sterile, 50 Filters per...EMD Millipore CorporationBSN
Z-1637-2010ADVANCE DURAMER TIBIAL INSERT, REF: KIMP-312R SIZE 3 RIGHT MEDIAL PIVOT, THICKNESS 12MM...Wright Medical Technology IncJWH
Z-1636-2010ADVANCE DURAMER TIBIAL INSERT, REF: KIMP-312L, SIZE 3 LEFT MEDIAL PIVOT, THICKNESS 12MM...Wright Medical Technology IncJWH
Z-1393-2010Lifeshield, latex-free, Y-Type Blood Set, yellow key slide clamp, 110 inch, nonvented...Abbott MedicalFPA
Z-1392-2010Lifeshield, latex-free, Y-Type Blood Set, nonvented, 100 inch with CLAVE and secure lock...Abbott MedicalFPA
Z-1391-2010Lifeshield, latex-free Secondary I.V. Set, convertible pin, 34 inch, piggyback with...Abbott MedicalFPA
Z-1390-2010Lifeshield, latex-free, Secondary I.V. Set, convertible pin, 32 inch, piggyback with...Abbott MedicalFPA
Z-1389-2010Lifeshield, latex-free Secondary I.V. Set, convertible pin, 32 inch, piggyback with...Abbott MedicalFPA
Z-1388-2010Lifeshield, latex-free, Secondary I.V. Set, convertible pin, 32 inch with OPTION-LOK...Abbott MedicalFPA
Z-1387-2010Lifeshield, latex-free, Primary I.V. Set, yellow key slide clamp, backcheck valve, 3...Abbott MedicalFPA
Z-1386-2010Lifeshield, latex-free, Primary I.V. Set, yellow key slide clamp, CLAVE Y-site, 15...Abbott MedicalFPA
Z-1385-2010Lifeshield, latex-free, Primary I.V. Set, yellow key slide clamp, backcheck valve, 3...Abbott MedicalFPA
Z-1384-2010Lifeshield, latex-free, Primary I.V. Set, yellow key slide clamp, 120 inch, convertible...Abbott MedicalFPA
Z-1383-2010Lifeshield, latex-free, Primary I.V. Set, yellow key slide clamp, 120 inch, convertible...Abbott MedicalFPA
Z-1382-2010Life shield Latex-Free Primary I.V. Set, yellow key slide clamp, 120 inch, convertible...Abbott MedicalFPA
Z-1381-2010Lifeshield Latex-Free Primary I.V. Set, yellow key slide clamp, MICRODRIP, backcheck...Abbott MedicalFPA
Z-1380-2010Lifeshield Latex-Free Primary I.V. Set, yellow key slide clamp, backcheck valve, 2 CLAVE...Abbott MedicalFPA
Z-1379-2010Lifeshield, latex-free, Primary I.V. Set, convertible pin, 110 inch with removable 3-port...Abbott MedicalFPA
Z-1378-2010Lifeshield, latex-free, Primary I.V. Set, convertible pin, 83 inch, MICRODRIP with...Abbott MedicalFPA
Z-1377-2010CONTINUUM, Lifeshield, latex-free, Primary I.V. Set, convertible pin, 112 inch with...Abbott MedicalFPA
Z-1376-2010Lifeshield, latex-free Primary I.V. Set, convertible pin, 83 inch with backcheck valve...Abbott MedicalFPA
Z-1375-2010Latex-free, Primary I.V. Set, convertible pin, 82 inch with OPTION-LOK, 15 drops/mL, a...Abbott MedicalFPA
Z-1374-2010Lifeshield, latex-free, Primary I.V. Set, convertible pin, 100 inch with OPTION-LOK and...Abbott MedicalFPA
Z-1373-2010Lifeshield, latex-free Primary I.V. Set, convertible pin, 110 inch, 0.2 micron filter...Abbott MedicalFPA
Z-1372-2010Life shield, latex-free, Primary I.V. Set, convertible pin, 100 inch with CALV and...Abbott MedicalFPA
Z-1371-2010Lifeshield, latex-free, Primary I.V. Set, convertible pin, 100 inch with backcheck valve...Abbott MedicalFPA
Z-1370-2010Lifeshield, latex-free Primary I.V. Set, convertible pin, 104 inch with nonphthalate...Abbott MedicalFPA
Z-1369-2010Lifeshield, latex-free Primary I.V. Set, convertible pin, 100 inch with backcheck valve...Abbott MedicalFPA
Z-1368-2010Lifeshield, latex-free Primary I.V. Set, convertible pin, 100 inch with backcheck valve...Abbott MedicalFPA
Z-1367-2010Lifeshield, latex-free Primary I.V. Set, convertible pin, 100 inch with backcheck valve...Abbott MedicalFPA
Z-1366-2010Lifeshield, latex-free Primary I.V. Set, convertible pin, 100 inch with backcheck valve...Abbott MedicalFPA
Z-1365-2010Lifeshield, latex-free, Primary I.V. Set, convertible pin, 100 inch with CLAVE ports and...Abbott MedicalFPA
Z-1364-2010Lifeshield, latex-free Primary I.V. Set, convertible pin, 80 inch with backcheck valve...Abbott MedicalFPA
Z-1363-2010Lifeshield, latex-free Primary I.V. Set, convertible pin, 78 inch with pre-pierced...Abbott MedicalFPA
Z-1362-2010Lifeshield, latex-free Primary I.V. Set, convertible pin, 80 inch with backcheck valve...Abbott MedicalFPA
Z-1361-2010Lifeshield, latex-free Primary I.V. Set, convertible pin, 106 inch with backcheck valve...Abbott MedicalFPA
Z-1360-2010Latex-free, Primary I.V. Set, vented, 73 inch with flashback bulb, 15 drops/mL, a sterile...Abbott MedicalFPA
Z-1359-2010Latex-free, Primary I.V. Set, vented, 78 inch with injection site, 15 drops/mL, a sterile...Abbott MedicalFPA
Z-1358-2010Lifeshield, latex-free Primary I.V. Pump Set with Distal Microbore Patient Line...Abbott MedicalFPA