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-0166-2009 | Alpha-Omega Services, Inc. Product No: NFV0001-004 Description: NEEDLE, FLEXIGUIDE... | Alpha Omega Services Inc | IWJ | ||
| Z-0927-2008 | Stryker Modular Replacement System Curved Cemented Stem; MRS 17x127 Curved Femoral Stem... | Howmedica Osteonics Corp | JDI | ||
| Z-0926-2008 | Stryker Modular Replacement System Curved Cemented Stem; MRS 15x127 Curved Femoral Stem... | Howmedica Osteonics Corp | JDI | ||
| Z-0925-2008 | Stryker Modular Replacement System Curved Cemented Stem; MRS 13x127 Curved Femoral Stem... | Howmedica Osteonics Corp | JDI | ||
| Z-0924-2008 | Stryker Modular Replacement System Curved Cemented Stem; MRS 11x127 Curved Femoral Stem... | Howmedica Osteonics Corp | JDI | ||
| Z-0923-2008 | Stryker Modular Replacement System Curved Cemented Stem; MRS 17mmx203 Femoral Stem... | Howmedica Osteonics Corp | JDI | ||
| Z-0922-2008 | Stryker Modular Replacement System Curved Cemented Stem; MRS 15mmx203mm Femoral Stem... | Howmedica Osteonics Corp | JDI | ||
| Z-0921-2008 | Stryker Modular Replacement System Curved Cemented Stem; MRS 12mmx203 Femoral Stem... | Howmedica Osteonics Corp | JDI | ||
| Z-0920-2008 | Stryker Modular Replacement System Curved Cemented Stem; MRS 11mmx203mm femoral stem... | Howmedica Osteonics Corp | JDI | ||
| Z-0919-2008 | Stryker Modular Replacement System Curved Cemented Stem; MRS Small Curved Femoral Stem 9... | Howmedica Osteonics Corp | JDI | ||
| Z-0918-2008 | Stryker Modular Replacement System Curved Cemented Stem; MRS Small Curved Femoral Stem... | Howmedica Osteonics Corp | JDI | ||
| Z-0917-2008 | Stryker Modular Replacement System Curved Cemented Stem; MRS SM Curved Femoral Stem... | Howmedica Osteonics Corp | JDI | ||
| Z-1236-2008 | Solar HA Humeral Stem with Plasma Coating 7mm to 17 mm Product Catalog Number... | Howmedica Osteonics Corp | KWS | ||
| Z-0692-2008 | GE Innova 4100 / 4100 IQ. , GE Healthcare, Waukesha, WI 53188 ( The system consists of an... | GE Healthcare | MQB | ||
| Z-0691-2008 | GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System, GE Healthcare, Waukesha, WI... | GE Healthcare | MQB | ||
| Z-0690-2008 | GE Innova 2100IQ Versatile Cardiac and Vascular Imaging System, GE Healthcare, Waukesha... | GE Healthcare | MQB | ||
| Z-0528-2008 | Baxter Renal Software Suite v.3.0 and v.3.1 - Renal Link HD Module; clinical data... | Baxter Healthcare Renal Div | KPF | ||
| Z-0527-2008 | Baxter RenalSoft v.2.0 Patient Management Software Suite - HD Module; clinical data... | Baxter Healthcare Renal Div | KPF | ||
| Z-0379-2008 | Roche Ammonia/Ethanol/CO2 Control A (Abnormal) for use in conjunction with Roche/Hitachi... | Roche Diagnostics GmbH | JJY | ||
| Z-0378-2008 | Roche Ammonia/Ethanol/CO2 Control N (Normal) for use in conjunction with Roche/Hitachi... | Roche Diagnostics GmbH | JJY | ||
| Z-0377-2008 | Roche Ammonia/Ethanol/CO2 Calibrator for use in conjunction with Roche/Hitachi, COBAS... | Roche Diagnostics GmbH | JIX | ||
| Z-0591-2008 | AngioSculpt PTCA Scoring Balloon Catheter, Catalog (REF) Number: 2027-2510, size 2.5mm x... | Spectranetics Corp. | NWX | ||
| Z-0575-2008 | BioRad BioPlex 2200 Software, for BioPlex 2200 Instrument, an automated immunodiagnostic... | Bio-Rad Laboratories Inc. | NVI | ||
| Z-1159-2008 | BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM: a) 100 test - Catalog No. 665-1150; and b)... | Bio-Rad Laboratories Inc. | LKJ | ||
| Z-1158-2008 | BIOPLEX 2200 EBV IgM KIT, CALIBRATORS, AND CONTROLS: 100 tests - Catalog No. 665-1350... | Bio-Rad Laboratories Inc. | LSE | ||
| Z-1157-2008 | BIOPLEX 2200 EBV IgG KIT, CALIBRATORS, AND CONTROLS: 100 tests - Catalog No. 665-1250... | Bio-Rad Laboratories Inc. | LSE | ||
| Z-1156-2008 | BIOPLEX 2200 SYPHILIS IgG Kit: 100 tests - Catalog No. 665-1450 - manufactured by Bio-Rad... | Bio-Rad Laboratories Inc. | LIP | ||
| Z-0451-2008 | Philips Medical Systems, M3290A IntelliVue Information Center Software for M3170... | Philips North America LLC | MHX | ||
| Z-1173-2010 | Xario; SSA-660A; software version 1.0 and later | Canon Medical Systems USA, Inc. | IYN | ||
| Z-1172-2010 | Aplio 80; SSA-770A; software version 5.5r002 | Canon Medical Systems USA, Inc. | IYN | ||
| Z-1171-2010 | Aplio 50; SSA-700A; software version 5.5r002 | Canon Medical Systems USA, Inc. | IYN | ||
| Z-2209-2008 | VectorVision (VV) Sky Navigation Platform (19" Computer Rack); the 19" computer rack is a... | Brainlab, Inc. | MUJ | ||
| Z-1441-2008 | Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device... | Medtronic Sofamor Danek USA Inc | NQP | ||
| Z-1440-2008 | Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device... | Medtronic Sofamor Danek USA Inc | NQP | ||
| Z-1439-2008 | Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device... | Medtronic Sofamor Danek USA Inc | NQP | ||
| Z-1438-2008 | Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device... | Medtronic Sofamor Danek USA Inc | NQP | ||
| Z-1437-2008 | Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device... | Medtronic Sofamor Danek USA Inc | NQP | ||
| Z-1436-2008 | Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device... | Medtronic Sofamor Danek USA Inc | NQP | ||
| Z-1435-2008 | Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device... | Medtronic Sofamor Danek USA Inc | NQP | ||
| Z-1434-2008 | Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device... | Medtronic Sofamor Danek USA Inc | NQP | ||
| Z-1433-2008 | Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device... | Medtronic Sofamor Danek USA Inc | NQP | ||
| Z-1432-2008 | Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device... | Medtronic Sofamor Danek USA Inc | NQP | ||
| Z-1431-2008 | Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device... | Medtronic Sofamor Danek USA Inc | NQP | ||
| Z-1430-2008 | Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device... | Medtronic Sofamor Danek USA Inc | NQP | ||
| Z-1429-2008 | Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device... | Medtronic Sofamor Danek USA Inc | NQP | ||
| Z-1428-2008 | Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device... | Medtronic Sofamor Danek USA Inc | NQP | ||
| Z-1427-2008 | Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device... | Medtronic Sofamor Danek USA Inc | NQP | ||
| Z-1426-2008 | Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device... | Medtronic Sofamor Danek USA Inc | NQP | ||
| Z-1425-2008 | Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device... | Medtronic Sofamor Danek USA Inc | NQP | ||
| Z-1424-2008 | Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device... | Medtronic Sofamor Danek USA Inc | NQP |