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-0117-2013 | Class II | HiRes 90K devices with Helix Electrodes Model CI 1400-02H The HiResolution Bionic Ear... | Advanced Bionics LLC | MCM | |
| Z-0667-2008 | Morton IUI Catheter, Sterile, Single Use Only, Order #: ftr510, Manufactured by Fertility... | Fertility Technology Resources, Inc. | MQF | ||
| Z-0666-2008 | Tucker Embryo Catheter for Trial Transfer, 20 cm, Order #: ftr320, Manufactured by... | Fertility Technology Resources, Inc. | MQF | ||
| Z-0665-2008 | Tucker Embryo Catheter with URM Tip, Embryo Transfer Catheter, 23 cm, Order #: ftr123... | Fertility Technology Resources, Inc. | MQF | ||
| Z-0664-2008 | Tucker Embryo Catheter with URM Tip, Embryo Transfer Catheter, 20 cm, Order #: ftr120... | Fertility Technology Resources, Inc. | MQF | ||
| Z-0210-2008 | Medtronic Sofamor Danek, 8 mm Trial, size 8 mm, Material Stainless Steel/Radel, quantity... | Medtronic Sofamor Danek USA Inc | LXH | ||
| Z-0209-2008 | Medtronic Sofamor Danek, 8 mm Curette, size 8 mm, Material Stainless Steel/Radel... | Medtronic Sofamor Danek USA Inc | LXH | ||
| Z-0208-2008 | Medtronic Sofamor Danek, Satellite System Sphere PEEK, Size 16 mm, Material PEEK-Optima... | Medtronic Sofamor Danek USA Inc | NVR | ||
| Z-0207-2008 | Medtronic Sofamor Danek, Satellite System Sphere PEEK, Size 15 mm, Material PEEK-Optima... | Medtronic Sofamor Danek USA Inc | NVR | ||
| Z-0206-2008 | Medtronic Sofamor Danek, Satellite System Sphere PEEK, Size 14 mm, Material PEEK-Optima... | Medtronic Sofamor Danek USA Inc | NVR | ||
| Z-0205-2008 | Medtronic Sofamor Danek, Satellite System Sphere PEEK, Size 13 mm, Material PEEK-Optima... | Medtronic Sofamor Danek USA Inc | NVR | ||
| Z-0204-2008 | Medtronic Sofamor Danek, Satellite System Sphere PEEK, Size 12 mm, Material PEEK-Optima... | Medtronic Sofamor Danek USA Inc | NVR | ||
| Z-0203-2008 | Medtronic Sofamor Danek, Satellite System Sphere PEEK, Size 11 mm, Material PEEK-Optima... | Medtronic Sofamor Danek USA Inc | NVR | ||
| Z-0202-2008 | Medtronic Sofamor Danek, Satellite System Sphere PEEK, Size 10 mm, Material PEEK-Optima... | Medtronic Sofamor Danek USA Inc | NVR | ||
| Z-0201-2008 | Medtronic Sofamor Danek, 16 mm Satellite Sphere CoCr, Size 16 mm, Quantity 1 each... | Medtronic Sofamor Danek USA Inc | NVR | ||
| Z-0200-2008 | Medtronic Sofamor Danek, 15 mm Satellite Sphere CoCr, Size 15 mm, Quantity 1 each... | Medtronic Sofamor Danek USA Inc | NVR | ||
| Z-0199-2008 | Medtronic Sofamor Danek, 14 mm Satellite Sphere CoCr, Size 14 mm, Quantity 1 each... | Medtronic Sofamor Danek USA Inc | NVR | ||
| Z-0198-2008 | Medtronic Sofamor Danek, 13 mm Satellite Sphere CoCr, Size 13 mm, Quantity 1 each... | Medtronic Sofamor Danek USA Inc | NVR | ||
| Z-0197-2008 | Medtronic Sofamor Danek, 12 mm Satellite Sphere CoCr, Size 12 mm, Quantity 1 each... | Medtronic Sofamor Danek USA Inc | NVR | ||
| Z-0196-2008 | Medtronic Sofamor Danek, 11 mm Satellite Sphere CoCr, Size 11 mm, Quantity 1 each... | Medtronic Sofamor Danek USA Inc | NVR | ||
| Z-0195-2008 | Medtronic Sofamor Danek, 10 mm Satellite Sphere CoCr, Size 10 mm, Quantity 1 each... | Medtronic Sofamor Danek USA Inc | NVR | ||
| Z-0194-2008 | Medtronic Sofamor Danek, 9 mm Satellite Sphere CoCr, Size 9 mm, Quantity 1 each, Material... | Medtronic Sofamor Danek USA Inc | NVR | ||
| Z-0193-2008 | Satellite Spinal System Surgical Technique, LITSATFUSST7-IRN10612/087, and LIT (DRAFT)... | Medtronic Sofamor Danek USA Inc | NVR | ||
| Z-0663-2008 | Tucker Embryo Catheter, Stylet, For use with Embryo Transfer Catheter, 20 cm, Sterile... | Fertility Technology Resources, Inc. | MQF | ||
| Z-0662-2008 | Tucker Embryo Catheter, Stylet, For use with Embryo Transfer Catheter, 23 CM, Sterile... | Fertility Technology Resources, Inc. | MQF | ||
| Z-0192-2008 | Satellite Spinal System Primary User Group Reference Guide, 8 1/2 by 11 inch plastic... | Medtronic Sofamor Danek USA Inc | NVR | ||
| Z-0564-2008 | POOLE Suction Instrument, Product Code: 0035040, 50/C. STERILE, EO, Rx ONLY... | ConMed Corporation | GCJ | ||
| Z-0563-2008 | FRAZIER Olive Tip Suction Instrument, 10 French with Control Vent and Obturator, Product... | ConMed Corporation | GCJ | ||
| Z-0562-2008 | FRAZIER Surgical Suction Instrument, 18 French with Obturator, Product Code: 0033180... | ConMed Corporation | GCJ | ||
| Z-0561-2008 | FRAZIER Surgical Suction Instrument, 12 French with Control Vent and Obturator, Product... | ConMed Corporation | GCJ | ||
| Z-0560-2008 | FRAZIER Surgical Suction Instrument, 10 French with Control Vent and Obturator, Product... | ConMed Corporation | GCJ | ||
| Z-0559-2008 | FRAZIER Surgical Suction Instrument, 8 French with Control Vent and Obturator, Product... | ConMed Corporation | GCJ | ||
| Z-0558-2008 | FRAZIER Atraumatic Soft Tip Surgical Suction Instrument with Control Vent and Obturator... | ConMed Corporation | GCJ | ||
| Z-0557-2008 | FRAZIER Surgical Suction Instrument, 7 French with Control Vent and Obturator (Bend with... | ConMed Corporation | GCJ | ||
| Z-0556-2008 | FRAZIER Surgical Suction Instrument, 5 French with Control Vent and Obturator, Product... | ConMed Corporation | GCJ | ||
| Z-0555-2008 | FRAZIER Surgical Suction Instrument, 3 French with Control and Obturator, Product Code... | ConMed Corporation | GCJ | ||
| Z-0124-2008 | Philips PageWriter Touch Cardiograph, Model: 860284, Philips Medical Systems, Andover... | Philips North America LLC | DPS | ||
| Z-0101-2008 | Steris QFC1728 and QFC1729 Quick Connects;(used to connect gastrointestinal endoscopes to... | STERIS Corporation | MED | ||
| Z-1915-2009 | Stryker Orthopaedics PAL Pelvic Alignment Level, Ref: PAL 400; Howmedica Osteonics Corp... | Howmedica Osteonics Corp | IQO | ||
| Z-0054-2008 | Lubricated Latex Condom. Labeled in part: "COMING TOGETHER IN DC", Distributed by Global... | Global Protection Corp. | HIS | ||
| Z-0126-2008 | Viasys Healthcare NicoletOne ICU Monitor, Modular Neurodiagnostic System (containing... | Medtronic, Inc. | GWQ | ||
| Z-0104-2008 | Boston Scientific mach 1 Guide Catheter, VL3.5 SH Voda Left 3.5, REF 34358-78, UPN... | Boston Scientific Corporation | DQY | ||
| Z-0103-2008 | Boston Scientific mach 1 Guide Catheter, 8F, FCL 3.5 SH Femoral Curve Left 3.5, REF... | Boston Scientific Corporation | DQY | ||
| Z-1367-2008 | Gambro cartridge blood tubing set used with Gambro Dasco Phoenix and Cobe Centrysystem 3... | Gambro Renal Products | KDI | ||
| Z-0545-2008 | Varian brand Clinac, Accelerator, Linear, Medical charged-particle radiation therapy... | Varian Medical Systems, Inc. | IYE | ||
| Z-0544-2008 | Varian brand Clinac, Accelerator, Linear, Medical charged-particle radiation therapy... | Varian Medical Systems, Inc. | IYE | ||
| Z-0265-2008 | GE Healthcare Advantage Workstations, Advantage Worksation version 4.2 and 4.3 with... | GE Healthcare | LLZ | ||
| Z-0109-2008 | Boston Scientific-Renegade Hi-Flo Microcatheter Kit, UPN Material Number... | Boston Scientific Corporation | KRA | ||
| Z-0125-2008 | Medtronic Sofamor Danek COLORADO 2" SPINAL SYSTEM Break-Off Nut, non-sterile, RX; Catalog... | Warsaw Orthopedic, Inc. | KWP | ||
| Z-0367-2008 | Philips Medical Systems, Cardiac Viewer or Pulmonary Viewer Application that can run on... | Philips North America LLC | JAK |