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-1609-2008 | VNUS Medical U-CLIP Removal Tool, UREM1860, is intended for the removal of U-Clip... | Medtronic Cardiac Surgery Technologies | FZP | ||
| Z-1632-2008 | STERRAD 100NX Sterilizer, Product Code 10104 Used to sterilize heat and moisture... | Advanced Sterilization Products | MLR | ||
| Z-1631-2008 | STERRAD NX Sterilizer, Product Code 10033 Used to sterilize heat and moisture sensitive... | Advanced Sterilization Products | MLR | ||
| Z-1630-2008 | STERRAD 200 Sterilization System, Product Code 10201 Used to sterilize heat and moisture... | Advanced Sterilization Products | MLR | ||
| Z-1629-2008 | STERRAD 50 Sterilization System, Product Code 10050 Used to sterilize heat and moisture... | Advanced Sterilization Products | MLR | ||
| Z-1628-2008 | STERRAD 100S Sterilization System, Product Code 10101 Used to sterilize heat and... | Advanced Sterilization Products | MLR | ||
| Z-1571-2008 | EUB-5500 VISION 5500 Diagnostic Ultrasound Scanner w/Step 5 (V05-7) Software. Imaging... | FUJIFILM Healthcare Americas Corporation | LHN | ||
| Z-1893-2008 | Edwards Lifesciences LLC, Fem-Flex II Femoral Venous Cannula, 12 Fr. x 11.5 cm, REF... | Edwards Lifesciences LLC | DWF | ||
| Z-1383-2008 | Warfarin Metabolism Nucleic Acid Test Cartridge; Part Number: 20-006-002; an in vitro... | Luminex Corporation | ODW | ||
| Z-1608-2008 | MT-APSD-2.4 Type-S Thermoplastic Mask, Medical charged-particle radiation therapy system... | CIVCO Medical Instruments Co., Inc. | IYE | ||
| Z-2038-2012 | Class I | OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System... | GE Healthcare | JAA | |
| Z-1641-2008 | CADD-MS"3 Ambulatory Infusion Pumps, Model 7400, Rx only, CE 0473, SN 499000. The... | Abbott Medical | FRN | ||
| Z-1591-2008 | Deltec Cozmo Insulin Pump, model 21-1800. This is similar to the currently distributed... | Abbott Medical | LZG | ||
| Z-1590-2008 | Deltec Cozmo Insulin Pump, model 21-1700. A syringe infusion pump designed for Continuous... | Abbott Medical | LZG | ||
| Z-1470-2008 | Replacement Kit, Power PCBA, REF 17345-001. only distributed outside the US. Pulmonetic... | Pulmonetic Systems, Inc. | CBK | ||
| Z-1615-2008 | TomoTherapy Hi-Art System with software versions 3.0 and 3.1 - Radiation Therapy System... | Accuray Incorporated | IYE | ||
| Z-1627-2008 | Gammas Set Screwdriver Instrument Set, Basic Stryker Trauma GmbH, Germany; Distributed by... | Howmedica Osteonics Corp | HXX | ||
| Z-1626-2008 | Gamma 3 System Set Screwdriver, Flexible Shaft; 4mm, This product is non-sterile Stryker... | Howmedica Osteonics Corp | HXX | ||
| Z-1469-2008 | Replacement Kit, Power PCBA with Memory PCBA. REF 14425. Pulmonetic Systems, 17400... | Pulmonetic Systems, Inc. | CBK | ||
| Z-1468-2008 | Replacement Kit, Power PCBA without Memory Board. REF 14157. Pulmonetic Systems, 17400... | Pulmonetic Systems, Inc. | CBK | ||
| Z-1349-2008 | Agfa IMPAX CardioVascular Suite Results Management Nuclear Reporting Module, Outbound... | AGFA Healthcare Corp. | LLZ | ||
| Z-1467-2008 | Replacement Kit, Power PCBA with DC power cord. REF 11590. Pulmonetic Systems, 17400... | Pulmonetic Systems, Inc. | CBK | ||
| Z-1466-2008 | Viasys healthcare, Pulmonetic Systems LTV 800 Ventilator The ventilator is suitable for... | Pulmonetic Systems, Inc. | CBK | ||
| Z-1465-2008 | Viasys healthcare, Pulmonetic Systems LTV 900 Ventilator The ventilator is suitable for... | Pulmonetic Systems, Inc. | CBK | ||
| Z-1464-2008 | Viasys healthcare, Pulmonetic Systems LTV 950 Ventilator The ventilator is suitable for... | Pulmonetic Systems, Inc. | CBK | ||
| Z-1463-2008 | Viasys Healthcare, Pulmonetic Systems LTV 1000 Ventilator The ventilator is suitable... | Pulmonetic Systems, Inc. | CBK | ||
| Z-0420-2012 | Single Use PERPOS PLS System, Catalog #9045-01 Catalog#9045-01 for Single Use PERPOS PLS... | Interventional Spine, Inc. | HTW | ||
| Z-0419-2012 | PERPOS 2-in-1 Drills, Catalog #6070 Component Part #6070 for PERPOS 2-in-1 Drill-a... | Interventional Spine, Inc. | HTW | ||
| Z-0406-2009 | ConMed Linvatec Hall Surgical Blades, Sterile THIN X-FINE, Catalog # L135 ConMed... | Linvatec Corporation | GET | ||
| Z-0405-2009 | ConMed Linvatec Hall Surgical Blades, Sterile STERILE REPL BLD/STRYKER, Catalog #... | Linvatec Corporation | GET | ||
| Z-0404-2009 | ConMed Linvatec Hall Surgical Blades, Sterile STERILE ACL BLD, Catalog # 00502318200... | Linvatec Corporation | GET | ||
| Z-0403-2009 | ConMed Linvatec Hall Surgical Blades, Sterile STER RPLCMNT BLADE/STRYKER RECIP, Catalog... | Linvatec Corporation | GET | ||
| Z-0402-2009 | ConMed Linvatec Hall Surgical Blades, Sterile STER REPT STERNTMY BLD, Catalog #... | Linvatec Corporation | GET | ||
| Z-0401-2009 | ConMed Linvatec Hall Surgical Blades, Sterile STER OSC BLD, Catalog # 00507118000... | Linvatec Corporation | GET | ||
| Z-0400-2009 | ConMed Linvatec Hall Surgical Blades, Sterile ST STERNUM SAW BLADES, Catalog #... | Linvatec Corporation | GET | ||
| Z-0399-2009 | ConMed Linvatec Hall Surgical Blades, Sterile ST SAGITTAL BLD FINE, Catalog #... | Linvatec Corporation | GET | ||
| Z-0398-2009 | ConMed Linvatec Hall Surgical Blades, Sterile ST SAG/OSC BLADE, Catalog # 00505928200... | Linvatec Corporation | GET | ||
| Z-0397-2009 | ConMed Linvatec Hall Surgical Blades, Sterile ST SAG BLADE, Catalog # 00502314400... | Linvatec Corporation | GET | ||
| Z-0396-2009 | ConMed Linvatec Hall Surgical Blades, Sterile ST SAG BLDE CRS, Catalog # 00502313300... | Linvatec Corporation | GET | ||
| Z-0395-2009 | ConMed Linvatec Hall Surgical Blades, Sterile ST SAG BLD FN 70D, Catalog #... | Linvatec Corporation | GET | ||
| Z-0394-2009 | ConMed Linvatec Hall Surgical Blades, Sterile ST REPL STRYKER SAG, Catalog #... | Linvatec Corporation | GET | ||
| Z-0393-2009 | ConMed Linvatec Hall Surgical Blades, Sterile ST REPL BLADE/STRYKER RECIP, Catalog #... | Linvatec Corporation | GET | ||
| Z-0392-2009 | ConMed Linvatec Hall Surgical Blades, Sterile ST REPL BLADE/SARNS STERNUM SAW, Catalog #... | Linvatec Corporation | GET | ||
| Z-0391-2009 | ConMed Linvatec Hall Surgical Blades, Sterile ST REPEAT STERN BLADE, Catalog #... | Linvatec Corporation | GET | ||
| Z-0390-2009 | ConMed Linvatec Hall Surgical Blades, Sterile ST RECIPROCATOR BLADE, Catalog #... | Linvatec Corporation | GET | ||
| Z-0389-2009 | ConMed Linvatec Hall Surgical Blades, Sterile ST OSCIL BLD,ME-92 COATED, Catalog #... | Linvatec Corporation | GET | ||
| Z-0388-2009 | ConMed Linvatec Hall Surgical Blades, Sterile ST OSCIL BLD, Catalog # 00507157200... | Linvatec Corporation | GET | ||
| Z-0387-2009 | ConMed Linvatec Hall Surgical Blades, Sterile ST OSCIL BLADE, ME-92 COAT, Catalog #... | Linvatec Corporation | GET | ||
| Z-0386-2009 | ConMed Linvatec Hall Surgical Blades, Sterile ST OSC BLDE, Catalog # 00507155200... | Linvatec Corporation | GET | ||
| Z-0385-2009 | ConMed Linvatec Hall Surgical Blades, Sterile ST OSC BLDE RADSD, Catalog #... | Linvatec Corporation | GET |