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-1637-2019 | Class II | Maquet Getinge- BEQ-TOP 5900 TCH 3/8 Quadrox-iD Pack Material:701050228R01 | Maquet Cardiovascular LLC | DWF | |
| Z-1636-2019 | Class II | Maquet Getinge-BEQ-TOP 24101 Adult ECC Pack Material:701050177R01 | Maquet Cardiovascular LLC | DWF | |
| Z-1635-2019 | Class II | Maquet Getinge- BEQ-TOP 24100 Small Patient ECC Pack Material:701050175R02 | Maquet Cardiovascular LLC | DWF | |
| Z-1741-2019 | Class II | Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item Number... | Zimmer GmbH | LXH | |
| Z-1740-2019 | Class II | Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item Number... | Zimmer GmbH | LXH | |
| Z-1739-2019 | Class II | Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item Number... | Zimmer GmbH | LXH | |
| Z-1738-2019 | Class II | Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item Number... | Zimmer GmbH | LXH | |
| Z-1737-2019 | Class II | Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item Number... | Zimmer GmbH | LXH | |
| Z-1736-2019 | Class II | Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item Number... | Zimmer GmbH | LXH | |
| Z-1634-2019 | Class II | Maquet Getinge-BEQ-TOP 21502 ECC Quadrox iD w/RF 3/8" Material:701050060R01 | Maquet Cardiovascular LLC | DWF | |
| Z-1633-2019 | Class II | Maquet Getinge-BEQ-TOP 22600 ECC QUADROX iD 3/8 Material:701049440R02 | Maquet Cardiovascular LLC | DWF | |
| Z-1632-2019 | Class II | Maquet Getinge-BEQ-TOP 22600 ECC QUADROX ID 3 Material:701049440R01 | Maquet Cardiovascular LLC | DWF | |
| Z-1708-2019 | Class II | Stryker Neurovascular, AXS Infinity LS Plus Long Sheath, Rx Only, Sterile EO, USA... | Stryker Corp. | DQY | |
| Z-1631-2019 | Class II | Maquet Getinge-BEQ-TOP 17207 3/8" ECC Pack Material:701049346R01 | Maquet Cardiovascular LLC | DWF | |
| Z-1630-2019 | Class II | Maquet Getinge-BEQ-TOP 5103 CPS Tubing Pack Material:701048690R01 | Maquet Cardiovascular LLC | DWF | |
| Z-1629-2019 | Class II | Maquet Getinge-BEQ-TOP 8013 ECC QUADROX iD Pack RF32 Material:701047962R01 | Maquet Cardiovascular LLC | DWF | |
| Z-1628-2019 | Class II | Maquet Getinge-BEQ-T 4932 Mercy Adaptation Pk Pediatric Material:709000520 | Maquet Cardiovascular LLC | DWF | |
| Z-1627-2019 | Class II | Maquet Getinge-BEQ-TOP 31604 CHKD 1/4" ECC Material: 709000518 | Maquet Cardiovascular LLC | DWF | |
| Z-1626-2019 | Class II | Maquet Getinge-BEQ-TOP 31603 CHKD 3/8" ECC Material: 709000516 | Maquet Cardiovascular LLC | DWF | |
| Z-1625-2019 | Class II | Maquet Getinge-BEQ-T 48003 Rotaflow ONLY Support Pack Material:709000490 | Maquet Cardiovascular LLC | DWF | |
| Z-1624-2019 | Class II | Maquet Getinge-BEQ-TOP 25503 TMC with BB & QiD Pedi Material:709000473 | Maquet Cardiovascular LLC | DWF | |
| Z-1623-2019 | Class II | Maquet Getinge-BEQ-TOP 8075 S-Quadrox iD Plus Pack wRF3 Material: 709000460 | Maquet Cardiovascular LLC | DWF | |
| Z-1622-2019 | Class II | Maquet Getinge-BEQ-T 48002 Bridge Kit Material: 709000444 | Maquet Cardiovascular LLC | DWF | |
| Z-1621-2019 | Class II | Maquet Getinge-BEQ-T 25502 1/4 Better Bladder Material: 709000434 | Maquet Cardiovascular LLC | DWF | |
| Z-1620-2019 | Class II | Maquet Getinge-BEQ-T 9410 Lurie Chldns Small 1/4 Material: 709000430 | Maquet Cardiovascular LLC | DWF | |
| Z-1619-2019 | Class II | Maquet Getinge-BEQ-T 9409 Lurie Chlds Large 3/8 Material: 709000428 | Maquet Cardiovascular LLC | DWF | |
| Z-1618-2019 | Class II | Maquet Getinge-T 5220 UAB Hospital Accessory Material: 709000426 | Maquet Cardiovascular LLC | DWF | |
| Z-1617-2019 | Class II | Maquet Getinge-BEQ-T 57000 Rotaflow Pack Material: 709000424 | Maquet Cardiovascular LLC | DWF | |
| Z-1616-2019 | Class II | Maquet Getinge-BEQ-T 27602 709000417 Adult Custom Pack Material: 709000417 | Maquet Cardiovascular LLC | DWF | |
| Z-1615-2019 | Class II | Maquet Getinge-BEQ-T 36507 Accessory Pk Mercy Material: 709000390 | Maquet Cardiovascular LLC | DWF | |
| Z-1614-2019 | Class II | Maquet Getinge-BO-T 51502 Ochsner ECC Adult Pack Material: 709000385 | Maquet Cardiovascular LLC | DWF | |
| Z-1613-2019 | Class II | Maquet Getinge-BEQ-T 25501 3/8" Better Bladder Pack Material: 709000370 | Maquet Cardiovascular LLC | DWF | |
| Z-1612-2019 | Class II | Maquet Getinge-BEQ-T 4917 Mercy Medical Versa-Pack Material: 709000368 | Maquet Cardiovascular LLC | DWF | |
| Z-1611-2019 | Class II | Maquet Getinge-T 8030 4 in High Flow Pigtail Material: 709000366 | Maquet Cardiovascular LLC | DWF | |
| Z-1610-2019 | Class II | Maquet Getinge-BEQ-T 5914 TCH Inch Change Kit Material: 709000334 | Maquet Cardiovascular LLC | DWF | |
| Z-1609-2019 | Class II | Maquet Getinge-BEQ-T 5915 TCH 3/8 Inch Change Kit Material: 709000280 | Maquet Cardiovascular LLC | DWF | |
| Z-1608-2019 | Class II | Maquet Getinge-BEQ-T 52301 Sash & Accessory Pack Material: 709000266 | Maquet Cardiovascular LLC | DWF | |
| Z-1607-2019 | Class II | Maquet Getinge-BEQ-T 53400 Adaption Pack Material: 709000213 | Maquet Cardiovascular LLC | DWF | |
| Z-1606-2019 | Class II | Maquet Getinge-BEQ-T 8506 Transport Pack Material: 709000146 | Maquet Cardiovascular LLC | DWF | |
| Z-1605-2019 | Class II | Maquet Getinge-BO-T 46201 Small Pediatric Cardiac Surge Material: 709000133 | Maquet Cardiovascular LLC | DWF | |
| Z-1604-2019 | Class II | Maquet Getinge-BO-T 52360 Cardioplegia Pack Material: 709000127 | Maquet Cardiovascular LLC | DWF | |
| Z-1603-2019 | Class II | Maquet Getinge-BEQ-T 51502 Ochsner ECC Ancillary Pack Material:709000115 | Maquet Cardiovascular LLC | DWF | |
| Z-1602-2019 | Class II | Maquet Getinge-BEQ-T 51501 Ochsner ECC Pack Material:709000113 | Maquet Cardiovascular LLC | DWF | |
| Z-1601-2019 | Class II | Maquet Getinge-BO-TOP 28903 Adult ECC Pack Material: 709000093 | Maquet Cardiovascular LLC | DWF | |
| Z-1600-2019 | Class II | Maquet Getinge-BEQ-TOP 50903 Custom ECC Pack-Pedriatric Material: 709000078 | Maquet Cardiovascular LLC | DWF | |
| Z-1599-2019 | Class II | Maquet Getinge-BEQ-T 28906 1/4" with Bridge Ancillary P Material: 709000072 | Maquet Cardiovascular LLC | DWF | |
| Z-1598-2019 | Class II | Maquet Getinge-BEQ-TOP 49103 ECC Pack 0 No Bladder Material: 709000058 | Maquet Cardiovascular LLC | DWF | |
| Z-1597-2019 | Class II | Maquet Getinge-BEQ-T 30914 ECC Pump Pack 1/4" Material: 709000011 | Maquet Cardiovascular LLC | DWF | |
| Z-1596-2019 | Class II | Maquet Getinge-BO-T 2302 Pediatric Cardiac Surgery Pack Material: 709000006 | Maquet Cardiovascular LLC | DWF | |
| Z-1595-2019 | Class II | Maquet Getinge-BO-T 2303 Small Adult Cardiac Surgery Material:709000004 | Maquet Cardiovascular LLC | DWF |