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 955 of 1190
FDA device recalls, page 955 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1853-2009Stryker 550 mL AutoFuser PainPump, dual site continuous, 4 mL/hr, 2 x 10.0 in. catheters...Stryker Corp.MEB
Z-1852-2009Stryker 550 mL AutoFuser PainPump, dual site continuous, 4 mL/hr, sterile, REF...Stryker Corp.MEB
Z-1851-2009Stryker 550 mL AutoFuser PainPump, single site continuous, 10 mL/hr, sterile, REF...Stryker Corp.MEB
Z-1850-2009Stryker 275 mL AutoFuser PainPump, single site continuous with bolus, 5 mL/hr, 2 mL...Stryker Corp.MEB
Z-1849-2009Stryker 275 mL AutoFuser PainPump, single site continuous, 5 mL/hr, 2 mL bolus, 60 minute...Stryker Corp.MEB
Z-1848-2009Stryker 275 mL AutoFuser PainPump, single site continuous, 5 mL/hr, 2 mL bolus, 60 minute...Stryker Corp.MEB
Z-1847-2009Stryker 275 mL AutoFuser PainPump, single site continuous, 5 mL/hr, 1 x 5.0 in. catheter...Stryker Corp.MEB
Z-1846-2009Stryker 275 mL AutoFuser PainPump, single site continuous, 5 mL/hr, 1 x 2.5 in. catheter...Stryker Corp.MEB
Z-1845-2009Stryker 275 mL AutoFuser PainPump, single site continuous, 5 mL/hr, standard catheter...Stryker Corp.MEB
Z-1844-2009Stryker 275 mL AutoFuser PainPump, single site continuous, 5 mL/hr, sterile, REF...Stryker Corp.MEB
Z-1843-2009Stryker 275 mL AutoFuser PainPump, dual site continuous, 4 mL/hr, 2 x 5.0 in. catheters...Stryker Corp.MEB
Z-1842-2009Stryker 275 mL AutoFuser PainPump, dual site continuous, 4 mL/hr, 2 x 2.5 in. catheter...Stryker Corp.MEB
Z-1841-2009Stryker 275 mL AutoFuser PainPump, dual site continuous, 4 mL/hr, 2 x 10 in. catheters...Stryker Corp.MEB
Z-1840-2009Stryker 275 mL AutoFuser PainPump, dual site continuous, 4 mL/hr, sterile, REF...Stryker Corp.MEB
Z-1839-2009Stryker 275 mL AutoFuser PainPump, single site continuous with bolus, 2 mL/hr, 2 mL...Stryker Corp.MEB
Z-1838-2009Stryker 275 mL AutoFuser PainPump, single site continuous with bolus, 2 mL/hr, 2 mL...Stryker Corp.MEB
Z-1837-2009Stryker 275 mL AutoFuser PainPump, single site continuous, 2 mL/hr, 2 mL bolus, 60 minute...Stryker Corp.MEB
Z-1836-2009Stryker 275 mL AutoFuser PainPump, single site continuous, 2 mL/hr, 1 x 5.0 in. catheter...Stryker Corp.MEB
Z-1835-2009Stryker 275 mL AutoFuser PainPump, single site continuous, 2 mL/hr, 1 x 2.5 in. catheter...Stryker Corp.MEB
Z-1834-2009Stryker 275 mL AutoFuser PainPump, single site continuous, 2 mL/hr,standard catheter...Stryker Corp.MEB
Z-1833-2009Stryker 275 mL AutoFuser PainPump, single site continuous, 2 mL/hr, sterile, REF...Stryker Corp.MEB
Z-1832-2009Stryker 100 mL AutoFuser PainPump, single site continuous with bolus, 2 mL/hr, 1 mL...Stryker Corp.MEB
Z-1831-2009Stryker 100 mL AutoFuser PainPump, single site continuous with bolus, 2 mL/hr, 1 mL...Stryker Corp.MEB
Z-1830-2009Stryker 100 mL AutoFuser PainPump, single site continuous with bolus, 2 mL/hr, 1 mL...Stryker Corp.MEB
Z-1829-2009Stryker 100 mL AutoFuser PainPump, single site continuous, 2 mL/hr, 1 mL bolus, 60 minute...Stryker Corp.MEB
Z-1828-2009Stryker 100 mL AutoFuser PainPump, dual site continuous, 2 mL/hr, 2 x 2.5 in. catheters...Stryker Corp.MEB
Z-1827-2009Stryker 100 mL AutoFuser PainPump, dual site continuous, 2 mL/hr, sterile, REF...Stryker Corp.MEB
Z-1826-2009Stryker 100 mL AutoFuser PainPump, single site continuous, 2 mL/hr, 1 x 2.5" catheter...Stryker Corp.MEB
Z-1825-2009Stryker 100 mL AutoFuser PainPump, single site continuous, 2.0 mL/hr, 1 x 2.5" standard...Stryker Corp.MEB
Z-1824-2009Stryker 100 mL AutoFuser PainPump, single site continuous, 2.0 mL/hr, sterile, REF...Stryker Corp.MEB
Z-1823-2009Stryker 100 mL AutoFuser PainPump, single site continuous, 1.0 mL/hr, 1 x 2.5" ExFen...Stryker Corp.MEB
Z-2568-2011XiO Radiation Treatment Planning System, XiO Release 4.3.0 through 4.50.00. Used to...Elekta Limitedmuj
Z-0190-2010Alphatec Spine, Inc., NOVEL SPINAL SPACER SYSTEM, Part Number(s): 64817-010, 64817-012...Alphatec Spine, Inc.MAX
Z-1595-2009Roche ACCU-CHEK Compact Plus Meter Kit, Roche Diagnostics, Indianapolis, IN; REFS...Roche Diagnostics GmbHLFR
Z-1594-2009Roche Coaguchex XS Systems for Patient Self-Testing, Roche Diagnostics, Indianapolis, IN...Roche Diagnostics GmbHGJS
Z-1593-2009Roche ACCU-Chek Aviva Meter Kit, Roche Diagnostics, Indianapolis, IN; REF 04893247001...Roche Diagnostics GmbHLFR
Z-1592-2009Roche ACCU-Chek Voicemate Meter, Roche Diagnostics, Indianapolis, IN; REF 12030802001...Roche Diagnostics GmbHLFR
Z-1591-2009Roche ACCU-Chek Active Meter Kit, Roche Diagnostics, Indianapolis, IN; REF 03184501001...Roche Diagnostics GmbHLFR
Z-1559-2009Dixtal Novametrix Neonatal/Pediatric SpO2 Sensor, Foam Wrap Style Catalog #...Dixtal Medical, Inc.DQA
Z-1590-2009Roche ACCU-CHEK Softclix Lancing Device, Distributed by Roche Diagnostics, Indianapolis...Roche Diagnostics GmbHFMK
Z-0794-2011Accessory Cart for The ACHIEVA 3.0T and Panorama 1T Magnetic Resonance Imaging...Philips North America LLCLNH
Z-1599-2009Cmax 110v Surgical Table Hand Control. The Cmax Surgical Table is a mobile...STERIS CorporationFQO
Z-1487-2009Boston Scientific, Fort Guide Wire, Floppy, 300cm x 2 cm REF 34949-04, for use in...Boston Scientific CorporationDQX
Z-1486-2009Boston Scientific Fort Guide Wire, Floppy Marker Wire, 300cm x 2 cm, REF 34949-02, for...Boston Scientific CorporationDQX
Z-1875-2009Flexicair MC3 (model M4000) Low Airloss Therapy Units, for the prevention of pressure...Hill-Rom Manufacturing, Inc.IOQ
Z-1874-2009Flexicair II (model 13000) Low Airloss Therapy Units, for the prevention of pressure...Hill-Rom Manufacturing, Inc.IOQ
Z-1479-2009Philips Avalon Fetal Monitor FM30; Model Number: M2703A.Philips North America LLCHGM
Z-1478-2009Philips Avalon Fetal Monitor FM20; Model Number: M2702A.Philips North America LLCHGM
Z-0462-2011Signa Excite" 1.5 T Magnetic Resonance Systems, manufactured by GE Healthcare, P.O. Box...GE HealthcareLNH
Z-1100-2010PET-511BTM Multi-plane transesophageal transducer (TEE) used with Toshiba Diagnostic...Canon Medical Systems USA, Inc.IYO