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-1149-06 | Auto Suture ChemoSite Low Profile Venous Access System with 9FR Introducer Kit with... | Medtronic, Inc. | FOZ | ||
| Z-1148-06 | Auto Suture-ChemoSite Low Profile -implantable low profile Venous Access System with... | Medtronic, Inc. | FOZ | ||
| Z-1307-06 | Abbott brand FreeStyle Flash Blood Glucose Meter, distributed by Abbott Diabetes Care... | Abbott Medical | NBW | ||
| Z-1306-06 | Abbott brand FreeStyle Blood Glucose Meter, distributed by Abbott Diabetes Care, 1420... | Abbott Medical | NBW | ||
| Z-0002-2007 | Guidant Zoom Latitude Programming System, Model 3120, Programmer/Recorder/Monitor (PRM)... | Boston Scientific Corporation | LWS | ||
| Z-1114-06 | Boston Scientific Stonetome Stone Removal Device, 20 mm tip, 30 mm cut wire, proximal... | Boston Scientific Corporation | LQR | ||
| Z-1113-06 | Boston Scientific Stonetome Stone Removal Device, 5 mm tip, 30 mm cut wire, proximal... | Boston Scientific Corporation | LQR | ||
| Z-1112-06 | Boston Scientific Stonetome Stone Removal Device, 20 mm tip, 20 mm cut wire, proximal... | Boston Scientific Corporation | LQR | ||
| Z-1111-06 | Boston Scientific Stonetome Stone Removal Device, 5 mm tip, 20 mm cut wire, proximal... | Boston Scientific Corporation | LQR | ||
| Z-1110-06 | Boston Scientific Stonetome Stone Removal Device, 20 mm tip, 30 mm cut wire, distal... | Boston Scientific Corporation | LQR | ||
| Z-1109-06 | Boston Scientific Stonetome Stone Removal Device, 20 mm tip, 20 mm cut wire, distal... | Boston Scientific Corporation | LQR | ||
| Z-1242-06 | Kimberly-Clark/Ballard medical R2 triangle shaped non-radiolucent multifunction electrode... | Kimberly-Clark Corporation | MKJ | ||
| Z-1241-06 | Kimberly-Clark/Ballard medical R2 triangle shaped non-radiolucent multifunction electrode... | Kimberly-Clark Corporation | MKJ | ||
| Z-1501-06 | Neoligaments Staple Impactor, 8 mm Staple Impactor: 202-3010 | Xiros Ltd | HXJ | ||
| Z-1500-06 | Neoligaments Staple Impactor, 6 mm Staple Impactor: 202-3001 | Xiros Ltd | HXJ | ||
| Z-0032-2007 | Gambro Prismaflex Hemodialysis Machine, Catalogue Number 6023014700, Gambro Dasco S.p.A... | Gambro Renal Products | KDI | ||
| Z-2089-2008 | NexStent Monorail Carotid Stent System, Material number M 001553000, Catalog number... | Boston Scientific Cupertino, Corporation | NIM | ||
| Z-1304-06 | GE Precision 500D Radiographic and Fluoroscopic Imaging System, Stationary X-ray System... | GE Healthcare | JAA | ||
| Z-1440-06 | UniCel DxC 600/600PRO/600i/800/800PRO Synchron Clinical Systems , Part Numbers... | Siemens Healthcare Diagnostics Inc. | NDW | ||
| Z-1194-06 | Guidant CONTAK RENEWAL 3 AVT (models M150, M155), CONTAK RENEWAL 3 AVT HE (models M157... | Boston Scientific Corporation | LWP | ||
| Z-1193-06 | VITALITY HE (model T180) Implantable Cardioverter Defibrillator (ICD). Sterile EO... | Boston Scientific Corporation | LWP | ||
| Z-1192-06 | Guidant CONTAK RENEWAL 3 (models H170, H173, H175), CONTAK RENEWAL 3 HE (models H177... | Boston Scientific Corporation | NIK | ||
| Z-1155-06 | Stryker Trio Mobile Surgery Platform; Model 1033. | Stryker Medical | FSE | ||
| Z-1292-06 | Guidant VITALITY 2 (models T165, T175), VITALITY DS (model T125), VITALITY EL (model... | Boston Scientific Corporation | LWP | ||
| Z-1291-06 | VITALITY AVT, model A155. Implantable Cardioverter Defibrillator. Atrial and Ventricular... | Boston Scientific Corporation | LWP | ||
| Z-1290-06 | CONTACT RENEWAL 4 AVT HE model numbers M177. Cardiac Resynchronization Therapy... | Boston Scientific Corporation | LWP | ||
| Z-1289-06 | These models are not available in the US. Guidant CONTAK RENEWAL 4 (models H190, H195)... | Boston Scientific Corporation | NIK | ||
| Z-1288-06 | Guidant CONTAK RENEWAL 3 (models H170, H175) CONTAK RENEWAL 3 HE (models H177, H179)... | Boston Scientific Corporation | NIK | ||
| Z-1154-06 | Stericover/ Sterile Disposible Polyethylene Drape ---Universal Video Camera/ Laser Arm... | Spinal Concepts, Inc. | KKX | ||
| Z-1175-06 | GYRUS ACMI PKS PlasmaSEAL Open Forceps, model 2103PK and 917015PK. Sterile EO. The... | Gyrus ACMI, Inc. | GEI | ||
| Z-0200-2007 | Gambro Phoenix Hemodialysis Machine, Model numbers: 6022933700, 6023006700, 6022966700... | Gambro Renal Products | KDI | ||
| Z-1257-06 | Soft Cosmetic Contact Lenses sold under the brand names: Circle Lens, Europa, Pacifica... | Hebron International, Inc. | LPL | ||
| Z-1238-06 | Boston Scientific Contour VL Injection Stent with Hydro Plus Coating, 6 FR (2.0 mm) x... | Boston Scientific Corporation | FAD | ||
| Z-0478-2008 | Hallmark Anterior Cervical Plate System: Primary Bone Screw, Semi Constrained, REF #... | Blackstone Medical, Inc. | KWQ | ||
| Z-1163-06 | B Braun 9F (O/S) Locking Tearway Introducers non-sterile. Catalog number 614008. The... | B Braun Medical Inc | DYB | ||
| Z-1601-2009 | Duracon Total Knee, A-P Lipped Tibial Insert; 11MM Sterile; Howmedica Osteonics... | Howmedica Osteonics Corp | JWH | ||
| Z-0079-2007 | CryoCath Frost Byte CryoSurgical Clamp, Model 60FB1, Manufacturer CryoCath Technologies... | Medtronic, Inc. (Minneapolis, MN 55447) | GEH | ||
| Z-1100-06 | Signify hCG Serum/Urine 30 Test Kit, Abbott List No. 07K09-30, ABI List No. 6026KSI... | Applied Biotech Inc | JHI | ||
| Z-1202-06 | Spacelabs Medical 1400 MHz Telemetry System,. Model 91341-09. Telemetry System consists... | GE Healthcare | DSI | ||
| Z-1248-06 | Prolieve Thermodilatation Kit, consisting of a Prolieve Thermodilatation Catheter... | Celsion Corporation | MEQ | ||
| Z-1174-06 | RapidScreen RS-Digital, Medical Image Analyzer. | Riverain Technologies | MYN | ||
| Z-1173-06 | RapidScreen RS-2000D, Medical Image Analyzer. | Riverain Technologies | MYN | ||
| Z-1087-06 | Coated Vicryl (polyglactin 910) suture. Needle Type CTXB Suture size: 1. Vicryl suture... | Ethicon, Inc | GAM | ||
| Z-1188-06 | ambIT Ambulatory Infusion Therapy Intermittent Pump | Sorenson Medical, Inc. | FRN | ||
| Z-0888-06 | XLie with Tubing, 12 cm, Electrosurgical Device-RITA * Medical Systems, Inc. * StarBurst... | Boston Scientific Corporation | GEI | ||
| Z-0887-06 | Talon Straight, 25 cm--Electrosurgical Device--RITA * Medical Systems, Inc. * StarBurst... | Boston Scientific Corporation | GEI | ||
| Z-1399-06 | GammaMed software program, version 5.07, vers. 5.08, vers.-usa, vers.-tst and vers.-row... | Varian Medical Systems, Inc. | JAQ | ||
| Z-1398-06 | GammaMed software program, version 5.07, vers. 5.08, vers.-usa, vers.-tst and vers.-row... | Varian Medical Systems, Inc. | JAQ | ||
| Z-1270-06 | GammaWin software, part number GM11019110, versions up to and including 1.62, for the... | Varian Medical Systems, Inc. | JAQ | ||
| Z-1269-06 | GammaWin software, part number GM11019110, versions up to and including 1.62, for the... | Varian Medical Systems, Inc. | JAQ |