Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR

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

59,460 records, page 1045 of 1190
FDA device recalls, page 1045 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1476-2008GE Definium 8000 , model 5135678, Digital Radiographic Systems. GE Healthcare, 3000...GE HealthcareJAA
Z-0555-2007Pyxis Anesthesia System 3500, Cardinal Health, Clinical Technologies and Services, San...CareFusion 303, IncBRY
Z-0288-2008Abbott Clinical Chemistry Aeroset/Architect (c Systems)Bilirubin Calibrator, List Number...Abbott MedicalJIX
Z-0013-2008Shelf Pack: Bard-Parker Rib-Back Stainless Steel no.11, surgical blade. Unit...Becton Dickinson & CoGES
Z-0012-2008Shelf Pack: Bard-Parker Rib-Back Carbon Steel no.11, surgical blade. Unit...Becton Dickinson & CoGES
Z-1218-2007PCS125 Swivel Collimator, Model F100; Manual Radiographic Collimator; Summit Industries...Summit Industries, LLCIZX
Z-1217-2007LX125V Swivel Collimator, Model E600; Manual Radiographic Collimator; Summit Industries...Summit Industries, LLCIZX
Z-1229-2007Guidewire, 70cm x 1mm, REF 5583705, Sterile, Single Use, BARD Access Systems...Bard Access Systems, Inc.MPB
Z-1216-2007LX125 Swivel Collimator, Model D800; Manual Radiographic Collimator; Summit Industries...Summit Industries, LLCIZX
Z-0102-2008Biomet Orthopedics Apical Hole Plug, 3/8 - 24 threaded, TI-6AL-4V alloy, sterile; REF...Zimmer GmbHLPH
Z-0010-2008EPIK KNEE SYSTEM Angled Insert Impactor RM/LL; Part #801-03-052 Rev. A; non-sterile; knee...Encore Medical, LPHWA
Z-0009-2008EPIK KNEE SYSTEM Angled Insert Impactor LM/RL; Catalog #801-03-051 Rev. A; non-sterile...Encore Medical, LPHRY
Z-0066-2008BD Microkeratome K3000 and K4000;Catalog Number: 378660, Becton Dickinson & Company (BD)Becton Dickinson & CoHMY
Z-0711-2008ConMed Linvatec, Ultrapower Burs, Linvatec Corporation, Largo, FL 33773Linvatec CorporationGFF
Z-1319-2008DIFCO Laboratories, FA Streptococcus Group A, 5mL, Catalog Number: 223181, Lot number...Lee Laboratories, Inc.GTQ
Z-0543-2008VNUS 7F ClosureFAST Catheter, Order # ClF7-7-100 (100 cm working length), Manufactured...Vnus Medical Technologies, Inc.GEI
Z-0542-2008VNUS 7F ClosureFAST Catheter, Order #: CF7-7-60 (60 cm working length), Manufactured by...Vnus Medical Technologies, Inc.GEI
Z-0185-2008Encore Reverse Shoulder Prosthesis (RSP) System, Standard Size 40 RSP Humeral Socket...Encore Medical, LPKWS
Z-0184-2008Encore Reverse Shoulder Prosthesis (RSP) System, Standard Size 36 RSP Humeral Socket...Encore Medical, LPKWS
Z-0687-2008Siemens Mevatron M-2 PRIMUS hi-energy Medical Charged-Particle Radiation Therapy System...Siemens Medical Solutions USA, Inc.IYE
Z-0686-2008Siemens Mevatron M-2 PRIMUS mid-energy Medical Charged-Particle Radiation Therapy System...Siemens Medical Solutions USA, Inc.IYE
Z-0685-2008Siemens Mevatron K-2 Medical Charged-Particle Radiation Therapy System; (Interlock #51...Siemens Medical Solutions USA, Inc.IYE
Z-0684-2008Seimens Mevatron M-2 6300 Medical Charged-Particle Radiation Therapy System; (Interlock...Siemens Medical Solutions USA, Inc.IYE
Z-0683-2008Seimens Mevatron M-2 6700 Medical Charged-Particle Radiation Therapy System; (Interlock...Siemens Medical Solutions USA, Inc.IYE
Z-0682-2008Siemens Mevatron MDX-2 Medical Charged-Particle Radiation Therapy System; (Interlock #51...Siemens Medical Solutions USA, Inc.IYE
Z-0681-2008Seimens Mevatron KD-2 Medical Charged-Particle Radiation Therapy System; (Interlock #51...Siemens Medical Solutions USA, Inc.IYE
Z-0680-2008Siemens Mevatron KDS-2 Medical Charged-Particle Radiation Therapy System; (Interlock #51...Siemens Medical Solutions USA, Inc.IYE
Z-0679-2008Siemens Mevatron M-2 6740 Medical Charged-Particle Radiation Therapy System; (Interlock...Siemens Medical Solutions USA, Inc.IYE
Z-0678-2008Siemens Mevatron MD2 Medical Charged-Particle Radiation Therapy System; (Interlock #51...Siemens Medical Solutions USA, Inc.IYE
Z-0677-2008Siemens Mevatron KD2 Medical Charged-Particle Radiation Therapy System; (Interlock #51...Siemens Medical Solutions USA, Inc.IYE
Z-2445-2008Universal Optical Tracker Fixation, not sterile, Manufactured by Orthosoft, Montreal...Zimmer GmbHHAW
Z-0957-2008Medtronic SynchroMed EL Programmable Pumps, Model 8627L-18, Medtronic, Inc., 710...Medtronic NeuromodulationLKK
Z-0956-2008Medtronic SynchroMed EL Programmable Pumps, Model 8627-18, Medtronic, Inc., 710...Medtronic NeuromodulationLKK
Z-0955-2008Medtronic SynchroMed EL Programmable Pumps, Model 8627L-10, Medtronic, Inc., 710...Medtronic NeuromodulationLKK
Z-0954-2008Medtronic SynchroMed EL Programmable Pumps, Model 8627-10, Medtronic, Inc., 710 Medtronic...Medtronic NeuromodulationLKK
Z-0953-2008Medtronic SynchroMed EL Programmable Pumps, Model 8626L-18, Medtronic, Inc., 710...Medtronic NeuromodulationLKK
Z-0952-2008Medtronic SynchroMed EL Programmable Pumps, Model 8626-18, Medtronic, Inc., 710...Medtronic NeuromodulationLKK
Z-0951-2008Medtronic SynchroMed EL Programmable Pumps, Model 8626L-10, Medtronic, Inc., 710...Medtronic NeuromodulationLKK
Z-0746-2008Medtronic SynchroMed EL Programmable Pump, Model 8627L-18. Medtronic, Inc., 710...Medtronic NeuromodulationLKK
Z-0745-2008Medtronic SynchroMed EL Programmable Pump, Model 8627-18. Medtronic, Inc., 710...Medtronic NeuromodulationLKK
Z-0744-2008Medtronic SynchroMed EL Programmable Pump, Model 8627L-10. Medtronic, Inc., 710 Medtronic...Medtronic NeuromodulationLKK
Z-0743-2008Medtronic SynchroMed EL Programmable Pump, Model 8627-10. Medtronic, Inc., 710 Medtronic...Medtronic NeuromodulationLKK
Z-0742-2008Medtronic SynchroMed EL Programmable Pump, Model 8626L-18. Medtronic, Inc., 710...Medtronic NeuromodulationLKK
Z-0741-2008Medtronic SynchroMed EL Programmable Pump, Model 8626-18. Medtronic, Inc., 710 Medtronic...Medtronic NeuromodulationLKK
Z-0740-2008Medtronic SynchroMed EL Programmable Pump, Model 8626L-10. Medtronic, Inc., 710...Medtronic NeuromodulationLKK
Z-0950-2008Medtronic SynchroMed EL Programmable Pumps, Models 8626-10, Medtronic, Inc., 710...Medtronic NeuromodulationLKK
Z-0055-2008Precision Implantable Pulse Generator (IPG), Model Number SC-110Advanced Bionics LLCLGW
Z-1221-2007Product is labeled as LTX XP Miniplant, Dental Implant, Sterile.ZimVie US Corp LLCDZE
Z-0739-2008Medtronic SynchroMed EL Programmable Pump, Model 8626-10. Medtronic, Inc., 710 Medtronic...Medtronic NeuromodulationLKK
Z-0099-2008Foundation Hip System Bipolar Modular, Size 60mm OD; Cat. #412-01-060; Sterile; assembly...Encore Medical, LPKWY