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-2064-2010 | Hemashield Finesse Ultra-thin Knitted Cardiovascular Patch. | Maquet Cardiovascular LLC | DSZ | ||
| Z-2063-2010 | Hemashield Platinum Woven and Knitted Double Velour Vascular Grafts. | Maquet Cardiovascular LLC | MAL | ||
| Z-2062-2010 | Hemashield Double Velour Cardiovascular Fabrics. | Maquet Cardiovascular LLC | DXZ | ||
| Z-2061-2010 | Hemashield Gold Woven Double Velour Vascular Branch Graft | Maquet Cardiovascular LLC | DSY | ||
| Z-1954-2010 | Stellant CT Dual Syringe Kits, Catalog Number SDS-CTP-QFT and SDS-CTP-SPK | Medrad, Inc. | DXT | ||
| Z-2195-2010 | IMMAGE Immunochemistry Systems Buffer 1 (BUF1), Part Number: 447650 | Siemens Healthcare Diagnostics Inc. | JQX | ||
| Z-1782-2010 | ReviveR AED semiautomatic external defibrillator used with the DBP-2800 Battery Pack... | Defibtech LLC | MKJ | ||
| Z-1781-2010 | Lifeline AED DDU-100 semiautomatic external defibrillator used with the DBP-2800 Battery... | Defibtech LLC | MKJ | ||
| Z-1824-2012 | Class II | HEPARIN LOCK FLUSH SOLUTION, USP, 10 USP Units/mL, 1 mL Multiple Dose Vial, plastic... | Fresenius Kabi USA, LLC | NZW | |
| Z-2581-2010 | Cardima Surgical Ablation Probe (SAP) Electrosurgical cutting and coagulation device... | Cardima, Inc. | OCL | ||
| Z-2580-2010 | Cardima Surgical Ablation Probe (SAP) Electrosurgical cutting and coagulation device... | Cardima, Inc. | OCL | ||
| Z-1825-2012 | Class II | HEPARIN LOCK FLUSH SOLUTION, USP, 100 USP Units/mL, 1 mL Multiple Dose Vial, plastic... | Fresenius Kabi USA, LLC | NZW | |
| Z-0282-2012 | Varian Medical Systems, Flexible Probe with Blocking Water, GM11002420, (Part of the... | Varian Medical Systems, Inc. | JAQ | ||
| Z-2604-2011 | XiO Radiation Treatment Planning System, XiO Release 4.50.00 and above | Elekta Limited | MUJ | ||
| Z-2175-2010 | CellTracks Auto Prep System, Circulating Tumor Cell Kit (epithelial, IVD Veridex, LLC a... | Veridex, LLC | GKH | ||
| Z-2025-2010 | Difco Salmonella 0 Group A Antigen, catalog #240731, packaged in 5 mL glass vials... | Becton Dickinson & Co | GNC | ||
| Z-1897-2010 | Lenstar LS 900, Biomicroscope, Slit-Lamp, AC-powered. HAAG-STREIT AG, Switzerland. Used... | Haag-Streit USA Inc | HLF | ||
| Z-2336-2010 | Mayfield Infinity XR2 Base Unit, model A-2079, manufactured by Integra LifeSciences... | Integra LifeSciences Corporation | FWZ | ||
| Z-2223-2010 | Disposable Surgical Cable, Product Code: FL-601-97 (100), Single use, Rx Only, Remington... | Remington Medical | DSA | ||
| Z-2724-2011 | IQecg IQiC Interface, Part Numbers: 4-100-1407, Software Version 6.0 IQecg is to be... | Brentwood Medical Technology Corp. | DSI | ||
| Z-0444-2011 | Zimmer Dental, Drill stop kit, REF DSKIT, for use with dental implants. | Zimmer GmbH | OFY | ||
| Z-2726-2011 | IQecg IQmanager Diagnostic Workstation, Part Numbers: 4-100-1200, Software Version 8.0.1... | Brentwood Medical Technology Corp. | DSI | ||
| Z-2725-2011 | IQecg IQdevices SDK, Part Numbers: 4-100-1403, Software Version 8.3.2 Product Usage... | Brentwood Medical Technology Corp. | DSI | ||
| Z-1873-2010 | Ultraflex Esophageal Stent System. Covered - Large - Proximal Release - 23/28/12/9... | Boston Scientific Corporation | ESW | ||
| Z-1872-2010 | Ultraflex Esophageal Stent System. Covered - Large - Proximal Release - 23/28/10/7... | Boston Scientific Corporation | ESW | ||
| Z-1871-2010 | Ultraflex Esophageal Stent System. Covered - Large - Distal Release - 23/28/12/9. Catalog... | Boston Scientific Corporation | ESW | ||
| Z-0367-2011 | MEDRAD Sterile Disposable Syringe Kit Recall, Catalog Number 150-FT-Q; Kit includes... | Medrad, Inc. | DXT | ||
| Z-1870-2010 | Ultraflex Esophageal Stent System. Covered - Large - Distal Release - 23/28/10/7. Catalog... | Boston Scientific Corporation | ESW | ||
| Z-1869-2010 | Ultraflex Esophageal Stent System. Covered - Proximal Release - 18/23/15/12. Catalog... | Boston Scientific Corporation | ESW | ||
| Z-1868-2010 | Ultraflex Esophageal Stent System. Covered - Proximal Release - 18/23/12/9. Catalog... | Boston Scientific Corporation | ESW | ||
| Z-1867-2010 | Ultraflex Esophageal Stent System. Covered - Proximal Release - 18/23/10/7. Catalog... | Boston Scientific Corporation | ESW | ||
| Z-1866-2010 | Ultraflex Esophageal Stent System. Uncovered - Proximal Release - 18/23/15. Catalog... | Boston Scientific Corporation | ESW | ||
| Z-1865-2010 | Ultraflex Esophageal Stent System. Uncovered - Proximal Release - 18/23/10. Catalog... | Boston Scientific Corporation | ESW | ||
| Z-1864-2010 | Ultraflex Esophageal Stent System. Uncovered - Proximal Release - 18/23/7. Catalog Number... | Boston Scientific Corporation | ESW | ||
| Z-1863-2010 | Ultraflex Esophageal Stent System. Covered - Distal Release - 18/23/15/12. Catalog Number... | Boston Scientific Corporation | ESW | ||
| Z-1862-2010 | Ultraflex Esophageal Stent System. Covered - Distal Release - 18/23/12/9. Catalog Number... | Boston Scientific Corporation | ESW | ||
| Z-1861-2010 | Ultraflex Esophageal Stent System. Covered - Distal Release - 18/23/10/7. Catalog Number... | Boston Scientific Corporation | ESW | ||
| Z-1860-2010 | Ultraflex Esophageal Stent System. Uncovered - Distal Release - 18/23/15. Catalog Number... | Boston Scientific Corporation | ESW | ||
| Z-1859-2010 | Ultraflex Esophageal Stent System. Uncovered - Distal Release - 18/23/10. Catalog Number... | Boston Scientific Corporation | ESW | ||
| Z-1858-2010 | Ultraflex Esophageal Stent System. Uncovered - Distal Release - 18/23/7. Catalog Number... | Boston Scientific Corporation | ESW | ||
| Z-1856-2010 | Ultraflex Tracheobronchial Stent System. Covered - 14/60 Catalog Number: M00569930... | Boston Scientific Corporation | JCT | ||
| Z-1855-2010 | Ultraflex Tracheobronchial Stent System. Uncovered - 14/40 Catalog Number: M00569920... | Boston Scientific Corporation | JCT | ||
| Z-1854-2010 | Ultraflex Tracheobronchial Stent System. Covered - 20/80/65 Catalog Number: M00569590... | Boston Scientific Corporation | JCT | ||
| Z-1853-2010 | Ultraflex Tracheobronchial Stent System. Covered - 20/60/45 Catalog Number: M00569580... | Boston Scientific Corporation | JCT | ||
| Z-1852-2010 | Ultraflex Tracheobronchial Stent System. Covered - 20/40/25 Catalog Number: M00569570... | Boston Scientific Corporation | JCT | ||
| Z-1851-2010 | Ultraflex Tracheobronchial Stent System. Covered - 18/80/65 Catalog Number: M00569560... | Boston Scientific Corporation | JCT | ||
| Z-1850-2010 | Ultraflex Tracheobronchial Stent System. Covered - 18/60/45 Catalog Number: M00569550... | Boston Scientific Corporation | JCT | ||
| Z-1849-2010 | Ultraflex Tracheobronchial Stent System. Covered - 18/40/25 Catalog Number: M00569540... | Boston Scientific Corporation | JCT | ||
| Z-1848-2010 | Ultraflex Tracheobronchial Stent System. Covered - 16/80/65 Catalog Number: M00569530... | Boston Scientific Corporation | JCT | ||
| Z-1847-2010 | Ultraflex Tracheobronchial Stent System. Covered - 16/60/45 Catalog Number: M00569520... | Boston Scientific Corporation | JCT |