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
| Recall number | Class | Product | Recalling firm | Product code | Initiated |
|---|---|---|---|---|---|
| Z-0634-2011 | 1.5 mm Inion CPS Baby , 2 hole plate, REF PLT-1004, sterile, Manufacturer, INION Oy... | Stryker Craniomaxillofacial Division | JEY | ||
| Z-0633-2011 | 1.5 mm Inion CPS Baby , X- plate 7 holes, REF PLT-1003, sterile, Manufacturer, INION Oy... | Stryker Craniomaxillofacial Division | JEY | ||
| Z-0632-2011 | 1.5 mm Inion CPS Baby , C- plate 7 holes, REF PLT-1002, sterile, Manufacturer, INION Oy... | Stryker Craniomaxillofacial Division | JEY | ||
| Z-2460-2010 | Brilliance iCT Heavyweight Gantry Scanner, M/N 728306, S/N: 100016, 100018 -100025 The... | Philips North America LLC | JAK | ||
| Z-1984-2011 | VARIANT nbs Sickle Program Resin Update CD-ROM; Model Number:250-3020, included in... | Bio-Rad Laboratories Inc. | GKA | ||
| Z-0631-2011 | 1.5 mm Inion CPS Baby , 20 hole plate, REF PLT-1001, sterile, Manufacturer, INION Oy... | Stryker Craniomaxillofacial Division | JEY | ||
| Z-0630-2011 | 1.5 mm Inion CPS Baby, 4 hole plate, REF PLT-1000, sterile, Manufacturer, INION Oy... | Stryker Craniomaxillofacial Division | JEY | ||
| Z-1971-2010 | Sure-Vue HSV-2 Rapid Test, Catalogue No: 23-046395. 20 test Kit In Vitro Diagnostic test... | Biokit USA, Inc. | LGC | ||
| Z-1617-2010 | Newport e360 Ventilator The e360 Ventilator System is intended to provide continuous... | Newport Medical Instruments, Inc. | CBK | ||
| Z-1807-2010 | Ulnar Shorting Saw Blade is labeled in part: "Congruent Bone Plates, SIZE Ulnar... | Acumed LLC | HRS | ||
| Z-3185-2011 | The 91220 mCare 300 Vital Signs monitor has a 10.4 inch resistive touchscreen... | GE Healthcare | MHZ | ||
| Z-1970-2010 | Biokit HSV-2 Rapid test Catalogue Number: 3000-28001. 20 test Kit. In Vitro... | Biokit USA, Inc. | LGC | ||
| Z-0915-2011 | Stryker Instruments, Interventional Spine RF MultiGen REF 0406-900-000, Rx only,, Stryker... | Stryker Corp. | GXD | ||
| Z-0914-2011 | Stryker Instruments, SmartPump Tourniquet System, Report Printer Kit, REF 5920-012-000... | Stryker Corp. | KCY | ||
| Z-0913-2011 | Stryker Instruments, SmartPump Tourniquet System, Single Channel Tourniquet Pump, REF... | Stryker Corp. | KCY | ||
| Z-0912-2011 | Stryker Instruments, SmartPump Tourniquet System, Dual Channel Tourniquet Pump, REF... | Stryker Corp. | KCY | ||
| Z-2400-2010 | Stratus CS Acute Care Troponin I TestPak ( Troponin I assay) | Siemens Healthcare Diagnostics Inc. | MMI | ||
| Z-1523-2010 | Shiley Specialized Tracheostomy Tube, M8DCT, Sterile EO, Made in Mexico, Tyco Healthcare... | Medtronic, Inc. | JOH | ||
| Z-1522-2010 | Shiley Specialized Tracheostomy Tube, M6DCT, Sterile EO, Made in Mexico, Tyco Healthcare... | Medtronic, Inc. | JOH | ||
| Z-1521-2010 | Shiley Specialized Tracheostomy Tube, MDCT, Sterile EO, Made in Mexico, Tyco Healthcare... | Medtronic, Inc. | JOH | ||
| Z-1520-2010 | Shiley Specialized Tracheostomy Tube, M8LPC, Sterile EO, Made in Mexico, Tyco Healthcare... | Medtronic, Inc. | JOH | ||
| Z-1519-2010 | Shiley Specialized Tracheostomy Tube, M6LPC, Sterile EO, Made in Mexico, Tyco Healthcare... | Medtronic, Inc. | JOH | ||
| Z-1518-2010 | Shiley Specialized Tracheostomy Tube, MLPC, Sterile EO, Made in Mexico, Tyco Healthcare... | Medtronic, Inc. | JOH | ||
| Z-1517-2010 | Shiley Specialized Tracheostomy Tube, M8FEN, Sterile EO, Made in Mexico, Tyco Healthcare... | Medtronic, Inc. | JOH | ||
| Z-1516-2010 | Shiley Specialized Tracheostomy Tube, M6FEN, Sterile EO, Made in Mexico, Tyco Healthcare... | Medtronic, Inc. | JOH | ||
| Z-1515-2010 | Shiley Specialized Tracheostomy Tube, MFEN, Sterile EO, Made in Mexico, Tyco Healthcare... | Medtronic, Inc. | JOH | ||
| Z-1514-2010 | Shiley Specialized Tracheostomy Tube, M5.5PLC, Sterile EO, Made in Mexico, Tyco... | Medtronic, Inc. | JOH | ||
| Z-1513-2010 | Shiley Specialized Tracheostomy Tube, MPLC, Sterile EO, Made in Mexico, Tyco Healthcare... | Medtronic, Inc. | JOH | ||
| Z-1512-2010 | Shiley Specialized Tracheostomy Tube, M5.5PDC, Sterile EO, Made in Mexico, Tyco... | Medtronic, Inc. | JOH | ||
| Z-1511-2010 | Shiley Specialized Tracheostomy Tube, M4.0PDC, Sterile EO, Made in Mexico, Tyco... | Medtronic, Inc. | JOH | ||
| Z-1510-2010 | Shiley Specialized Tracheostomy Tube, MPDC, Sterile EO, Made in Mexico, Tyco Healthcare... | Medtronic, Inc. | JOH | ||
| Z-1509-2010 | Shiley Specialized Tracheostomy Tube, M10SCT, Sterile EO, Made in Mexico, Tyco Healthcare... | Medtronic, Inc. | JOH | ||
| Z-1508-2010 | Shiley Specialized Tracheostomy Tube, M9SCT, Sterile EO, Made in Mexico, Tyco Healthcare... | Medtronic, Inc. | JOH | ||
| Z-1507-2010 | Shiley Specialized Tracheostomy Tube, M8SCT, Sterile EO, Made in Mexico, Tyco Healthcare... | Medtronic, Inc. | JOH | ||
| Z-1506-2010 | Shiley Specialized Tracheostomy Tube, M7.5SCT, Sterile EO, Made in Mexico, Tyco... | Medtronic, Inc. | JOH | ||
| Z-1505-2010 | Shiley Specialized Tracheostomy Tube, M7SCT, Sterile EO, Made in Mexico, Tyco Healthcare... | Medtronic, Inc. | JOH | ||
| Z-1504-2010 | Shiley Specialized Tracheostomy Tube, M6.5SCT, Sterile EO, Made in Mexico, Tyco... | Medtronic, Inc. | JOH | ||
| Z-1503-2010 | Shiley Specialized Tracheostomy Tube, M6SCT, Sterile EO, Made in Mexico, Tyco Healthcare... | Medtronic, Inc. | JOH | ||
| Z-1502-2010 | Shiley Specialized Tracheostomy Tube, M5.5SCT, Sterile EO, Made in Mexico, Tyco... | Medtronic, Inc. | JOH | ||
| Z-1501-2010 | Shiley Specialized Tracheostomy Tube, M5SCT, Sterile EO, Made in Mexico, Tyco Healthcare... | Medtronic, Inc. | JOH | ||
| Z-1500-2010 | Shiley Specialized Tracheostomy Tube, MSCT, Sterile EO, Made in Mexico, Tyco Healthcare... | Medtronic, Inc. | JOH | ||
| Z-1499-2010 | Shiley Cuffed Long Pediatric Tracheostomy Tube, 6.5 PLC, Assembled in Mexico, Tyco... | Medtronic, Inc. | JOH | ||
| Z-1498-2010 | Shiley Cuffed Long Pediatric Tracheostomy Tube, 6.0 PLC, Assembled in Mexico, Tyco... | Medtronic, Inc. | JOH | ||
| Z-1497-2010 | Shiley Cuffed Long Pediatric Tracheostomy Tube, 5.5 PLC, Assembled in Mexico, Tyco... | Medtronic, Inc. | JOH | ||
| Z-1496-2010 | Shiley Cuffed Long Pediatric Tracheostomy Tube, 5.0 PLC, Assembled in Mexico, Tyco... | Medtronic, Inc. | JOH | ||
| Z-1495-2010 | Shiley Cuffed Pediatric Tracheostomy Tube, 5.5 PDC, Assembled in Mexico, Tyco Healthcare... | Medtronic, Inc. | JOH | ||
| Z-1494-2010 | Shiley Cuffed Pediatric Tracheostomy Tube, 5.0 PDC, Assembled in Mexico, Tyco Healthcare... | Medtronic, Inc. | JOH | ||
| Z-1493-2010 | Shiley Cuffed Pediatric Tracheostomy Tube, 4.5 PDC, Assembled in Mexico, Tyco Healthcare... | Medtronic, Inc. | JOH | ||
| Z-1492-2010 | Shiley Cuffed Pediatric Tracheostomy Tube, 4.0 PDC, Assembled in Mexico, Tyco Healthcare... | Medtronic, Inc. | JOH | ||
| Z-1491-2010 | Shiley Low Pressure Cuffed Tracheostomy Tube with Evacuation Line, 10 LPC-S, Assembled in... | Medtronic, Inc. | JOH |