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-1476-2008 | GE Definium 8000 , model 5135678, Digital Radiographic Systems. GE Healthcare, 3000... | GE Healthcare | JAA | ||
| Z-0555-2007 | Pyxis Anesthesia System 3500, Cardinal Health, Clinical Technologies and Services, San... | CareFusion 303, Inc | BRY | ||
| Z-0288-2008 | Abbott Clinical Chemistry Aeroset/Architect (c Systems)Bilirubin Calibrator, List Number... | Abbott Medical | JIX | ||
| Z-0013-2008 | Shelf Pack: Bard-Parker Rib-Back Stainless Steel no.11, surgical blade. Unit... | Becton Dickinson & Co | GES | ||
| Z-0012-2008 | Shelf Pack: Bard-Parker Rib-Back Carbon Steel no.11, surgical blade. Unit... | Becton Dickinson & Co | GES | ||
| Z-1218-2007 | PCS125 Swivel Collimator, Model F100; Manual Radiographic Collimator; Summit Industries... | Summit Industries, LLC | IZX | ||
| Z-1217-2007 | LX125V Swivel Collimator, Model E600; Manual Radiographic Collimator; Summit Industries... | Summit Industries, LLC | IZX | ||
| Z-1229-2007 | Guidewire, 70cm x 1mm, REF 5583705, Sterile, Single Use, BARD Access Systems... | Bard Access Systems, Inc. | MPB | ||
| Z-1216-2007 | LX125 Swivel Collimator, Model D800; Manual Radiographic Collimator; Summit Industries... | Summit Industries, LLC | IZX | ||
| Z-0102-2008 | Biomet Orthopedics Apical Hole Plug, 3/8 - 24 threaded, TI-6AL-4V alloy, sterile; REF... | Zimmer GmbH | LPH | ||
| Z-0010-2008 | EPIK KNEE SYSTEM Angled Insert Impactor RM/LL; Part #801-03-052 Rev. A; non-sterile; knee... | Encore Medical, LP | HWA | ||
| Z-0009-2008 | EPIK KNEE SYSTEM Angled Insert Impactor LM/RL; Catalog #801-03-051 Rev. A; non-sterile... | Encore Medical, LP | HRY | ||
| Z-0066-2008 | BD Microkeratome K3000 and K4000;Catalog Number: 378660, Becton Dickinson & Company (BD) | Becton Dickinson & Co | HMY | ||
| Z-0711-2008 | ConMed Linvatec, Ultrapower Burs, Linvatec Corporation, Largo, FL 33773 | Linvatec Corporation | GFF | ||
| Z-1319-2008 | DIFCO Laboratories, FA Streptococcus Group A, 5mL, Catalog Number: 223181, Lot number... | Lee Laboratories, Inc. | GTQ | ||
| Z-0543-2008 | VNUS 7F ClosureFAST Catheter, Order # ClF7-7-100 (100 cm working length), Manufactured... | Vnus Medical Technologies, Inc. | GEI | ||
| Z-0542-2008 | VNUS 7F ClosureFAST Catheter, Order #: CF7-7-60 (60 cm working length), Manufactured by... | Vnus Medical Technologies, Inc. | GEI | ||
| Z-0185-2008 | Encore Reverse Shoulder Prosthesis (RSP) System, Standard Size 40 RSP Humeral Socket... | Encore Medical, LP | KWS | ||
| Z-0184-2008 | Encore Reverse Shoulder Prosthesis (RSP) System, Standard Size 36 RSP Humeral Socket... | Encore Medical, LP | KWS | ||
| Z-0687-2008 | Siemens Mevatron M-2 PRIMUS hi-energy Medical Charged-Particle Radiation Therapy System... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-0686-2008 | Siemens Mevatron M-2 PRIMUS mid-energy Medical Charged-Particle Radiation Therapy System... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-0685-2008 | Siemens Mevatron K-2 Medical Charged-Particle Radiation Therapy System; (Interlock #51... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-0684-2008 | Seimens Mevatron M-2 6300 Medical Charged-Particle Radiation Therapy System; (Interlock... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-0683-2008 | Seimens Mevatron M-2 6700 Medical Charged-Particle Radiation Therapy System; (Interlock... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-0682-2008 | Siemens Mevatron MDX-2 Medical Charged-Particle Radiation Therapy System; (Interlock #51... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-0681-2008 | Seimens Mevatron KD-2 Medical Charged-Particle Radiation Therapy System; (Interlock #51... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-0680-2008 | Siemens Mevatron KDS-2 Medical Charged-Particle Radiation Therapy System; (Interlock #51... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-0679-2008 | Siemens Mevatron M-2 6740 Medical Charged-Particle Radiation Therapy System; (Interlock... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-0678-2008 | Siemens Mevatron MD2 Medical Charged-Particle Radiation Therapy System; (Interlock #51... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-0677-2008 | Siemens Mevatron KD2 Medical Charged-Particle Radiation Therapy System; (Interlock #51... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-2445-2008 | Universal Optical Tracker Fixation, not sterile, Manufactured by Orthosoft, Montreal... | Zimmer GmbH | HAW | ||
| Z-0957-2008 | Medtronic SynchroMed EL Programmable Pumps, Model 8627L-18, Medtronic, Inc., 710... | Medtronic Neuromodulation | LKK | ||
| Z-0956-2008 | Medtronic SynchroMed EL Programmable Pumps, Model 8627-18, Medtronic, Inc., 710... | Medtronic Neuromodulation | LKK | ||
| Z-0955-2008 | Medtronic SynchroMed EL Programmable Pumps, Model 8627L-10, Medtronic, Inc., 710... | Medtronic Neuromodulation | LKK | ||
| Z-0954-2008 | Medtronic SynchroMed EL Programmable Pumps, Model 8627-10, Medtronic, Inc., 710 Medtronic... | Medtronic Neuromodulation | LKK | ||
| Z-0953-2008 | Medtronic SynchroMed EL Programmable Pumps, Model 8626L-18, Medtronic, Inc., 710... | Medtronic Neuromodulation | LKK | ||
| Z-0952-2008 | Medtronic SynchroMed EL Programmable Pumps, Model 8626-18, Medtronic, Inc., 710... | Medtronic Neuromodulation | LKK | ||
| Z-0951-2008 | Medtronic SynchroMed EL Programmable Pumps, Model 8626L-10, Medtronic, Inc., 710... | Medtronic Neuromodulation | LKK | ||
| Z-0746-2008 | Medtronic SynchroMed EL Programmable Pump, Model 8627L-18. Medtronic, Inc., 710... | Medtronic Neuromodulation | LKK | ||
| Z-0745-2008 | Medtronic SynchroMed EL Programmable Pump, Model 8627-18. Medtronic, Inc., 710... | Medtronic Neuromodulation | LKK | ||
| Z-0744-2008 | Medtronic SynchroMed EL Programmable Pump, Model 8627L-10. Medtronic, Inc., 710 Medtronic... | Medtronic Neuromodulation | LKK | ||
| Z-0743-2008 | Medtronic SynchroMed EL Programmable Pump, Model 8627-10. Medtronic, Inc., 710 Medtronic... | Medtronic Neuromodulation | LKK | ||
| Z-0742-2008 | Medtronic SynchroMed EL Programmable Pump, Model 8626L-18. Medtronic, Inc., 710... | Medtronic Neuromodulation | LKK | ||
| Z-0741-2008 | Medtronic SynchroMed EL Programmable Pump, Model 8626-18. Medtronic, Inc., 710 Medtronic... | Medtronic Neuromodulation | LKK | ||
| Z-0740-2008 | Medtronic SynchroMed EL Programmable Pump, Model 8626L-10. Medtronic, Inc., 710... | Medtronic Neuromodulation | LKK | ||
| Z-0950-2008 | Medtronic SynchroMed EL Programmable Pumps, Models 8626-10, Medtronic, Inc., 710... | Medtronic Neuromodulation | LKK | ||
| Z-0055-2008 | Precision Implantable Pulse Generator (IPG), Model Number SC-110 | Advanced Bionics LLC | LGW | ||
| Z-1221-2007 | Product is labeled as LTX XP Miniplant, Dental Implant, Sterile. | ZimVie US Corp LLC | DZE | ||
| Z-0739-2008 | Medtronic SynchroMed EL Programmable Pump, Model 8626-10. Medtronic, Inc., 710 Medtronic... | Medtronic Neuromodulation | LKK | ||
| Z-0099-2008 | Foundation Hip System Bipolar Modular, Size 60mm OD; Cat. #412-01-060; Sterile; assembly... | Encore Medical, LP | KWY |
