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-1051-2008 | Draeger TI500. Isolette Infant Incubator. Catalog Number: MU20505. Draeger Medical... | Draeger, Inc. | FMZ | ||
| Z-0475-2009 | GE Innova 4100 /4100 IQ. , GE Healthcare, Waukesha, WI 53188 ( The system consists of an... | GE Healthcare | MQB | ||
| Z-0474-2009 | GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System, GE Healthcare, Waukesha, WI... | GE Healthcare | MQB | ||
| Z-0473-2009 | GE Innova 2100IQ Versatile Cardiac and Vascular Imaging System, GE Healthcare, Waukesha... | GE Healthcare | MQB | ||
| Z-1765-2008 | X-STOP Interspinous Process Decompression (lPD) System, (With Physician's Guide, P/N... | Medtronic, Inc. | NQO | ||
| Z-1459-2008 | High-Definition 120 MultiLeaf Collimator, Medical charged-particle radiation therapy... | Varian Medical Systems, Inc. | IYE | ||
| Z-2333-2008 | Permanent Pacing Lead (Catalog #: 03332, 03334, 03337, 03107, 03116, 03108, 03109, 05756... | Oscor Inc. | DTB | ||
| Z-1509-2008 | Surgivac Wound Drainage Device, 400 ml Surgivac 1/4" PVC w/trocar, 6,4mm, 19Fr, PVC... | Zimmer GmbH | GCY | ||
| Z-1508-2008 | Surgivac Wound Drainage Device, 400 ml Surgivac 1/4" MP SIL w/trocar, 6,4mm, 19Fr, Si... | Zimmer GmbH | GCY | ||
| Z-1507-2008 | Surgivac Wound Drainage Device, 400 ml Surgivac 3/16" MP SIL w/trocar, 4,8mm, 15Fr, Si... | Zimmer GmbH | GCY | ||
| Z-1506-2008 | Surgivac Wound Drainage Device, 400 ml Surgivac 1/8" MP Sil w/trocar, 3,2mm, 10Fr, Si... | Zimmer GmbH | GCY | ||
| Z-1505-2008 | Surgivac Wound Drainage Device, 400 ml Surgivac 3/16" PVC w/trocar, 4,8mm, 15Fr, PVC... | Zimmer GmbH | GCY | ||
| Z-1504-2008 | Surgivac Wound Drainage Device, 400 ml Surgivac Component Kit, sterile, latex free, Rx... | Zimmer GmbH | GCY | ||
| Z-1503-2008 | Surgivac Wound Drainage Device, 400 ml Surgivac 1/8" PVC w/trocar, 3,2mm, 10Fr, PVC... | Zimmer GmbH | GCY | ||
| Z-1502-2008 | Zimmer Hemovac Wound Drainage Device with O.P. Adapter, 400 ml COMP EVAC w/O.P. Adapter... | Zimmer GmbH | GCY | ||
| Z-1501-2008 | Zimmer Hemovac Wound Drainage Device, 400 ml COMP EVAC 3/32" PVC w/trocar, 2,4mm, 7Fr... | Zimmer GmbH | GCY | ||
| Z-1500-2008 | Zimmer Hemovac Wound Drainage Device, 400 ml EVAC 1/4" DR w/troc spec., 6,4mm, 19Fr, PVC... | Zimmer GmbH | GCY | ||
| Z-1499-2008 | Zimmer Hemovac Wound Drainage Device, 400 ml COMP EVAC 1/4" PVC w/trocar, 6,4mm, 19Fr... | Zimmer GmbH | GCY | ||
| Z-1498-2008 | Zimmer Hemovac Wound Drainage Device, 400 ml COMP EVAC 1/4" PVC w/trocar (4"), 6,4mm... | Zimmer GmbH | GCY | ||
| Z-1497-2008 | Zimmer Hemovac Wound Drainage Device, 100 ml Hemovac Mini Evacuator, sterile, latex free... | Zimmer GmbH | GCY | ||
| Z-1496-2008 | Zimmer Hemovac Wound Drainage Device, Infection Control Kits, Mini-Hemovac I.C. Kit... | Zimmer GmbH | GCY | ||
| Z-1495-2008 | Zimmer Hemovac Wound Drainage Device, Infection Control Kits, 400ml INF. CNTRL. Kit w/... | Zimmer GmbH | GCY | ||
| Z-1494-2008 | Zimmer Hemovac Wound Drainage Device, Infection Control Kits, 400ml INF. CNTRL. Kit w/... | Zimmer GmbH | GCY | ||
| Z-1493-2008 | Zimmer Hemovac Wound Drainage Device, Infection Control Kits, 400ml INF. CNTRL. Kit w/... | Zimmer GmbH | GCY | ||
| Z-1492-2008 | Zimmer Hemovac Wound Drainage Device, Infection Control Kits, 400ml INF. CNTRL. Kit w/... | Zimmer GmbH | GCY | ||
| Z-1491-2008 | Zimmer Hemovac Wound Drainage Device, Infection Control Kits, 400ml INF. CNTRL. Kit w/... | Zimmer GmbH | GCY | ||
| Z-1490-2008 | Zimmer Hemovac Wound Drainage Device, Infection Control Kits, 400ml INF. CNTRL. Kit w/... | Zimmer GmbH | GCY | ||
| Z-1489-2008 | Zimmer Hemovac Wound Drainage Device, Infection Control Kits, 400ml INF. CNTRL. Kit w/... | Zimmer GmbH | GCY | ||
| Z-1488-2008 | Zimmer Hemovac Wound Drainage Device, 400ml Comp Bonded Evac 3/16" PVC w/trocar, 4,8mm... | Zimmer GmbH | GCY | ||
| Z-1487-2008 | Zimmer Hemovac Wound Drainage Device, 400ml Comp Evac 3/16" PVC w/trocar, 4,8mm, 15Fr... | Zimmer GmbH | GCY | ||
| Z-1486-2008 | Zimmer Hemovac Wound Drainage Device, 400ml Comp Bonded Evac 1/8" PVC w/trocar, 3,2mm... | Zimmer GmbH | GCY | ||
| Z-1485-2008 | Zimmer Hemovac Wound Drainage Device, 400ml Comp Evac 1/8" PVC w/trocar, 3,2mm, 10Fr... | Zimmer GmbH | GCY | ||
| Z-1484-2008 | Zimmer H.A.S. Autotransfusion System, H.A.S. Kit without Drain, sterile, latex free, Rx... | Zimmer GmbH | CAC | ||
| Z-1483-2008 | Zimmer H.A.S. Autotransfusion System, H.A.S. Replacement Kit, sterile, latex free, Rx... | Zimmer GmbH | CAC | ||
| Z-1482-2008 | Zimmer H.A.S. Autotransfusion System, H.A.S. Kit with 1/4" Drain, 6,4mm, 19Fr, PVC... | Zimmer GmbH | CAC | ||
| Z-1481-2008 | Zimmer H.A.S. Autotransfusion System, H.A.S. Kit with 3/16" Soft Drain , 4,8mm, 15Fr... | Zimmer GmbH | CAC | ||
| Z-1480-2008 | Zimmer H.A.S. Autotransfusion System, H.A.S. Kit with 1/8" Drain , 3,2mm, 10Fr, PVC... | Zimmer GmbH | CAC | ||
| Z-1444-2008 | Philips Medical Systems iSite PACS (Picture Archiving and Communications Systems) version... | Philips North America LLC | LLZ | ||
| Z-1443-2008 | Philips Medical Systems iSite PACS (Picture Archiving and Communications Systems) version... | Philips North America LLC | LLZ | ||
| Z-1313-2008 | Cardiovascular Procedure Kit, P/N 70579-04, St. Louis University Hospital Pump & Table... | Terumo Cardiovascular Systems Corporation | OEZ | ||
| Z-1312-2008 | Cardiovascular Procedure Kit, P/N 70295-02, St. Louis University Hospital Pump & Table... | Terumo Cardiovascular Systems Corporation | OEZ | ||
| Z-1311-2008 | Cardiovascular Procedure Kit, P/N 64789-01, Wisconsin Cardiovascular Services Pump and... | Terumo Cardiovascular Systems Corporation | OEZ | ||
| Z-1310-2008 | Cardiovascular Procedure Kit, P/N: 70932-01, HCSG-St. Mary's Hospital, Richmond, VA... | Terumo Cardiovascular Systems Corporation | OEZ | ||
| Z-2036-2008 | Internal Defibrillation Electrodes: PN: 805355-10 thru 14 and 805355-020 thru -024. | Physio Control, Inc. | LDD | ||
| Z-2035-2008 | Physio-Control Internal Defibrillator Handles. PN: 3010901-002 for use with LIFEPAK 12... | Physio Control, Inc. | LDD | ||
| Z-1904-2011 | Zoll Auto Pulse Resuscitation System; Zoll Circulation Inc., Sunnyvale, CA 94085 Cardiac... | ZOLL Circulation, Inc. | DRM | ||
| Z-1476-2011 | PrecisePLAN Treatment Planning System To plan multiple beam radiation therapy treatments. | Elekta Limited | MUJ | ||
| Z-1235-2008 | AMS In-Fast Ultra Kit with Polypropylene Suture, REF 72403885. Sterile Transvaginal... | American Medical Systems, Inc. | MBI | ||
| Z-1191-2008 | INTEGRA NeuroSensor Probe, REF NS-P, component of Cerebral Blood Flow and Intracranial... | Natus Medical Incorporated | GWM | ||
| Z-1297-2008 | Stryker Orthopaedics, Locking Screw, T7, Catalog Number: 40-27622, Size: 2.7X22MM, Non... | Howmedica Osteonics Corp | HRS |