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-1490-2010 | Shiley Low Pressure Cuffed Tracheostomy Tube with Evacuation Line, 8 LPC-S, Assembled in... | Medtronic, Inc. | JOH | ||
| Z-1489-2010 | Shiley Low Pressure Cuffed Tracheostomy Tube with Evacuation Line, 6 LPC-S, Assembled in... | Medtronic, Inc. | JOH | ||
| Z-1488-2010 | Shiley Low Pressure Cuffed Tracheostomy Tube with Evacuation Line, 4 LPC-S, Assembled in... | Medtronic, Inc. | JOH | ||
| Z-1487-2010 | Shiley Single Cannula Cuffed Tracheostomy Tube, 10 SCT, Assembled in Mexico, Tyco... | Medtronic, Inc. | BTO | ||
| Z-1486-2010 | Shiley Single Cannula Cuffed Tracheostomy Tube, 9 SCT, Assembled in Mexico, Tyco... | Medtronic, Inc. | BTO | ||
| Z-1485-2010 | Shiley Single Cannula Cuffed Tracheostomy Tube, 8 SCT, Assembled in Mexico, Tyco... | Medtronic, Inc. | BTO | ||
| Z-1484-2010 | Shiley Single Cannula Cuffed Tracheostomy Tube, 7 SCT, Assembled in Mexico, Tyco... | Medtronic, Inc. | BTO | ||
| Z-1483-2010 | Shiley Single Cannula Cuffed Tracheostomy Tube, 6 SCT, Assembled in Mexico, Tyco... | Medtronic, Inc. | BTO | ||
| Z-1482-2010 | Shiley Single Cannula Cuffed Tracheostomy Tube, 5 SCT, Assembled in Mexico, Tyco... | Medtronic, Inc. | BTO | ||
| Z-1481-2010 | Shiley Low Pressure Cuffed Tracheostomy Tube, 10 LPC, Assembled in Mexico, Tyco... | Medtronic, Inc. | JOH | ||
| Z-1480-2010 | Shiley Low Pressure Cuffed Tracheostomy Tube, 8 LPC, Assembled in Mexico, Tyco Healthcare... | Medtronic, Inc. | JOH | ||
| Z-1479-2010 | Shiley Low Pressure Cuffed Tracheostomy Tube, 6 LPC, Assembled in Mexico, Tyco Healthcare... | Medtronic, Inc. | JOH | ||
| Z-1478-2010 | Shiley Low Pressure Cuffed Tracheostomy Tube, 4 LPC, Assembled in Mexico, Tyco Healthcare... | Medtronic, Inc. | JOH | ||
| Z-1477-2010 | Shiley Fenestrated Low Pressure Cuffed Tracheostomy Tube with Evacuation Line, 8 FEN-S... | Medtronic, Inc. | JOH | ||
| Z-1476-2010 | Shiley Fenestrated Low Pressure Cuffed Tracheostomy Tube with Evacuation Line, 6 FEN-S... | Medtronic, Inc. | JOH | ||
| Z-1475-2010 | Shiley Percutaneous Dual Cannula Tracheostomy Tube, 8 PERC, Assembled in Mexico, Tyco... | Medtronic, Inc. | JOH | ||
| Z-1474-2010 | Shiley Percutaneous Dual Cannula Tracheostomy Tube, 6 PERC, Assembled in Mexico, Tyco... | Medtronic, Inc. | JOH | ||
| Z-1473-2010 | Shiley Disposable Cannula Fenestrated Low Pressure Cuffed Tracheostomy Tube, 10 DFEN... | Medtronic, Inc. | JOH | ||
| Z-1472-2010 | Shiley Disposable Cannula Fenestrated Low Pressure Cuffed Tracheostomy Tube, 8 DFEN... | Medtronic, Inc. | JOH | ||
| Z-1471-2010 | Shiley Disposable Cannula Fenestrated Low Pressure Cuffed Tracheostomy Tube, 6 DFEN... | Medtronic, Inc. | JOH | ||
| Z-1470-2010 | Shiley Disposable Cannula Fenestrated Low Pressure Cuffed Tracheostomy Tube, 4 DFEN... | Medtronic, Inc. | JOH | ||
| Z-1469-2010 | Shiley Fenestrated Low Pressure Cuffed Tracheostomy Tube, 10 FEN, Assembled in Mexico... | Medtronic, Inc. | JOH | ||
| Z-1468-2010 | Shiley Fenestrated Low Pressure Cuffed Tracheostomy Tube, 8 FEN, Assembled in Mexico... | Medtronic, Inc. | JOH | ||
| Z-1467-2010 | Shiley Fenestrated Low Pressure Cuffed Tracheostomy Tube, 6 FEN, Assembled in Mexico... | Medtronic, Inc. | JOH | ||
| Z-1466-2010 | Shiley Fenestrated Low Pressure Cuffed Tracheostomy Tube, 4 FEN, Assembled in Mexico... | Medtronic, Inc. | JOH | ||
| Z-1465-2010 | Shiley Disposable Cannula Low Pressure Cuffed Tracheostomy Tube, 10 DCT, Assembled in... | Medtronic, Inc. | JOH | ||
| Z-1464-2010 | Shiley Disposable Cannula Low Pressure Cuffed Tracheostomy Tube, 8 DCT, Assembled in... | Medtronic, Inc. | JOH | ||
| Z-1463-2010 | Shiley Disposable Cannula Low Pressure Cuffed Tracheostomy Tube, 6 DCT, Assembled in... | Medtronic, Inc. | JOH | ||
| Z-1462-2010 | Shiley Disposable Cannula Low Pressure Cuffed Tracheostomy Tube, 4 DCT, Assembled in... | Medtronic, Inc. | JOH | ||
| Z-0075-2011 | Pathfinder End Screw Extender Sleeve, REF 1165-10, Rx, non-sterile, sold under label... | Zimmer GmbH | NKB | ||
| Z-1732-2010 | Axiom Artis systems with Motor Controller Unit. Siemens Medical Solutions USA, Inc... | Siemens Medical Solutions USA, Inc. | MQB | ||
| Z-0461-2011 | The Dimension NTP and LNTP Flex reagent cartridge (N- Terminal Pro- Brain Natriuretic... | Siemens Healthcare Diagnostics Inc. | NBC | ||
| Z-0460-2011 | The Dimension TNI Flex reagent cartridge (Cardiac Troponin), manufactured by Siemens... | Siemens Healthcare Diagnostics Inc. | MMI | ||
| Z-0459-2011 | The Dimension TSHL Flex reagent cartridge (Thyroid Stimulating Hormone) manufactured by... | Siemens Healthcare Diagnostics Inc. | JLW | ||
| Z-0458-2011 | The Dimension FT4L Flex reagent cartridge( Free Thyroxine) manufactured by Siemens... | Siemens Healthcare Diagnostics Inc. | CEC | ||
| Z-1816-2010 | Excyte Slider Barcode Tube Adapter used with Excyte Vacuum or Non-Vacuum ESR Tubes... | ELITechGroup Inc | GHC | ||
| Z-1895-2010 | Hospira brand Symbiq Two-Channel Infuser; List Number: 16027; Distributed by: Hospira... | Abbott Medical | FRN | ||
| Z-1894-2010 | Hospira brand Symbiq One-Channel Infuser; List Number: 16026; Distributed by: Hospira... | Abbott Medical | FRN | ||
| Z-2204-2011 | CHVH-001A/1B Variable Helical Pitch (vHP) Software for TSX-101A: Aquilion 64; System... | Canon Medical Systems USA, Inc. | JAK | ||
| Z-2438-2010 | Integrated Data Management System - Version 7.1, 7.2 and 7.3; ITC Corporation, 8 Olsen... | Accriva Diagnostics, Inc. | JQP | ||
| Z-1595-2010 | Basic Core Pack # OR1805, Sterile, Tri State Hospital Supply Corporation Manufacturers... | Centurion Medical Products, LP | GEI | ||
| Z-1920-2010 | MIRA CR4060 68 mm Finger Probe 68mm surf ace x 37mm Length Intended for the... | Mira, Inc. | HPS | ||
| Z-1919-2010 | MIRA CR4055 25mm Finger Probe 25mm surface x 30mm Length Intended for the destruction... | Mira, Inc. | HPS | ||
| Z-1918-2010 | MIRA CR4050 12mm Finger Probe 12mm surface x 27mm Length Intended for the destruction... | Mira, Inc. | HPS | ||
| Z-1779-2010 | RAYHACK DRILL GUIDE ANGLED, REF 4010-0206, 1 EACH, Rx ONLY, NON-STERILE, Wright Medical... | Wright Medical Technology Inc | LXH | ||
| Z-1536-2010 | Bard Ventrio Small Oval Hernia Patch 8cm X 12cm (3.1" x 4.7"), Warwick, RI Product Code... | Davol Inc., Sub. C.R. Bard, Inc. | FTL | ||
| Z-1605-2010 | Universal Flat Panel Yoke, a component of the Stryker Flat Panel Arm. The yoke is... | STRYKER Communications, Inc. | BRY | ||
| Z-1618-2010 | HeartStart MRx Defibrillator Monitor, Model M3535A HeartStart MRx Defibrillator Monitor... | Philips North America LLC | MKJ | ||
| Z-0823-2012 | The 45mm Left Standard Offset Mandible is one component in the Total Temporomandibular... | Biomet Microfixation | MPL | ||
| Z-0822-2012 | The 45mm Left Standard Mandible is one component in the Total Temporomandibular Joint... | Biomet Microfixation | MPL |