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-1867-2008 | Stryker Ureteral Universal Kit, Model number 220-180-517, The ureteral kit is a ureteral... | Stryker Corp. | FCS | ||
| Z-1866-2008 | Stryker Ureteral Kit, Model number 220-180-516, The ureteral kit is a ureteral... | Stryker Corp. | FCS | ||
| Z-1930-2008 | Medtronic Catheter, Cannula and Tubing, for Vascular Cardiopulmonary Bypass. This... | Medtronic Perfusion Systems | DWF | ||
| Z-1929-2008 | Medtronic Bio-Medicus Percutaneous Cannula & Introducer Set, Catalog Number: CB96535-015 | Medtronic Perfusion Systems | DQY | ||
| Z-1928-2008 | Medtronic Bio-Medicus Femoral Cannula/Introducer, for Cardiopulmonary Bypass. Catalog... | Medtronic Perfusion Systems | DWF | ||
| Z-1927-2008 | Medtronic Arterial Cannula Curved Beveled Tip, for Cardiopulmonary Bypass. Catalog... | Medtronic Perfusion Systems | DWF | ||
| Z-1926-2008 | Medtronic Select 3D and Select CAP Aterial Cannulae with flexible, thin wall wire-wound... | Medtronic Perfusion Systems | DWF | ||
| Z-1925-2008 | Medtronic Arterial Cannula Straight Beveled tip, for Cardiopulmonary Bypass. Catalog... | Medtronic Perfusion Systems | DWF | ||
| Z-1924-2008 | Medtronic Malleable Single Stage Venous Cannula with Carmeda BioActive Surface, for... | Medtronic Perfusion Systems | DWF | ||
| Z-1923-2008 | Medtronic Venous Cannula with bent tip wire, for vascular cardiopulmonary bypass... | Medtronic Perfusion Systems | DWF | ||
| Z-1922-2008 | Medtronic AFFINITY NT Hollow Fiber Oxygenator with Plasma Resistant fiber with Carmeda... | Medtronic Perfusion Systems | DTZ | ||
| Z-1921-2008 | Medtronic Affinity Pediatric arterial Filter, Arterial Line Filter for Cardiopulmonary... | Medtronic Perfusion Systems | DTM | ||
| Z-1920-2008 | Medtronic Extracorporeal Circuit with bio-active surface; Cardiopulmonary Bypass... | Medtronic Perfusion Systems | DTZ | ||
| Z-1855-2008 | Bard Recovery Cone Removal System, Catalog Numbers: FBRC. The device is intended for... | Bard Peripheral Vascular Inc | GAE | ||
| Z-1854-2008 | Bard Recovery Cone Removal System, Catalog Numbers: RC-15. The device is intended for... | Bard Peripheral Vascular Inc | GAE | ||
| Z-1919-2008 | Medtronic AFFINITY NT Hollow Fiber Oxygenator with Carmeda BioActive Surface, CB511, with... | Medtronic Perfusion Systems | DTN | ||
| Z-1825-2008 | GE Centricity AW Suite 2.0 Software running on the Centricity RA 1000 or RA600/CA1000... | GE Healthcare | LLZ | ||
| Z-1957-2009 | Genicon, RX Only, Sterile EO. Genicon 6869 Stapoint Court, Suite 114 Winter Park, FL... | Genicon, Inc. | GCY | ||
| Z-1956-2009 | Genicon, RX Only, Sterile EO. Genicon 6869 Stapoint Court, Suite 114 Winter Park, FL... | Genicon, Inc. | GCY | ||
| Z-2152-2008 | Vitrex Blood Gas Capillary Tubes, MC0024, REF 189301, 250 pcs, 1,45 x 1,85 x 125 mm app... | Opti Medical Systems Inc | GIO | ||
| Z-1868-2008 | Encore Modular Femoral Neck, 12 degree/35 mm; Ref #410-35-112; distributed by Encore... | Encore Medical, LP | JDI | ||
| Z-2058-2008 | Cook Hilal Embolization Microcoil, 6 mm, sterile. The device is an intravascular implant... | Cook Incorporated | HCG | ||
| Z-2057-2008 | Cook Hilal Embolization Microcoil, 3 mm, sterile. The device is an intravascular implant... | Cook Incorporated | HCG | ||
| Z-1858-2008 | Physio-Control LIFEPAK 12 defibrillator/monitor. The LIFEPAK12 defibrillator/monitor... | Physio Control, Inc. | MKJ | ||
| Z-1725-2013 | Class II | Finger Sensor for Remmers Recorder (Formerly SnoreSat Sleep recorder) To be used to... | Sagatech Electronics, Inc. | MNR | |
| Z-2233-2008 | Hamilton Soft Grip Pipettes, 1 ml adjustable volume, model number 55019-40 Product is... | Hamilton Co | JQW | ||
| Z-2232-2008 | Hamilton Soft Grip Pipettes, 1 ml fixed volume, model number 55019-19 Product is... | Hamilton Co | JQW | ||
| Z-2012-2008 | Trauma Fixation Systems - The Slotted Mallet is an auxiliary optional instrument... | Ebi, LLC | FZY | ||
| Z-2005-2008 | Medtronic Trillium AFFINITY NT, 511T, Hollow Fiber Oxygenator with Trillium Biopassive... | Medtronic Perfusion Systems | DRY | ||
| Z-1878-2008 | Hawkins III Breast Localization Needle. Product number 243075. The product is used in... | Medical Device Technologies, Inc. | GAA | ||
| Z-1812-2008 | Depuy LCS Knee - Orthopedic knee implant. Meniscal bearing insert, Sz: STD, mm thick 12... | Depuy Orthopaedics Inc. | NJL | ||
| Z-1826-2008 | GE Centricity PACS RA1000 Workstation; for diagnostic image analysis. GE Healthcare... | GE Healthcare | LLZ | ||
| Z-2154-2008 | Corometrics MODEL 250 Series Maternal/ Fetal Monitor, Models 256 and 259, part number... | GE Healthcare | HGM | ||
| Z-2351-2008 | InterGro DBM Demineralized Bone Matrix in a lipid carrier; Provided by: Lifelink Tissue... | Michigan Orthopaedic Products, Inc. | MQV | ||
| Z-1651-2008 | Ambulift Classic, battery powered patient lift. The Ambulift is used to move and lift... | Arjo, Inc. | FSA | ||
| Z-1650-2008 | Ambulift, standard basic model manually powered patient lift. The Ambulift is used to... | Arjo, Inc. | FSA | ||
| Z-0915-2009 | Tibial Array and Femoral Array. Model Number(s): 0150ARR00001 and... | Mako Surgical Corp. | HAW | ||
| Z-1861-2008 | Gambro Cartridge Blood Set, 0141080XXXC, is intended for single use in a hemodialysis... | Gambro Renal Products | FJK | ||
| Z-1860-2008 | Gambro Cartridge Blood Set, 003410-510, is intended for single use in a hemodialysis... | Gambro Renal Products | FJK | ||
| Z-2006-2008 | iReview" Software (Accessory To) iLab Ultrasound Imaging System, Model Number... | Boston Scientific Corporation | IYN | ||
| Z-0287-2013 | Class II | PT Link Waterbath, Model#PT100. Lab Vision PT Module Plus provides an automated... | Agilent Technologies, Inc. | IDY | |
| Z-2145-2008 | GE Precision RXi Digital remote X-Ray Imaging R&F System, model 5117828. GE Medical... | GE Healthcare | JAA | ||
| Z-2144-2008 | GE Precision MPi, model 2398238. GE Medical Systems - Americas, Milwaukee, USA The... | GE Healthcare | JAA | ||
| Z-2143-2008 | GE Precision MPi, model 2385125. GE Medical Systems - Americas, Milwaukee, USA The... | GE Healthcare | JAA | ||
| Z-2142-2008 | GE Precision MPi, model 5126893. GE Medical Systems - Americas, Milwaukee, USA The... | GE Healthcare | JAA | ||
| Z-2312-2008 | Advantage Workstation version 4.2P, 4.3 and 4.4 with Volume Viewer 2 and Volume Viewer 3... | GE Healthcare | LLZ | ||
| Z-2182-2008 | Medtronic Synchromed II Programmable Pump , Medtronic Inc., Minneapolis, MN 55432-5604 40... | Medtronic Neuromodulation | LKK | ||
| Z-2181-2008 | Medtronic Synchromed II Programmable Pump , Medtronic Inc., Minneapolis, MN 55432-5604 20... | Medtronic Neuromodulation | LKK | ||
| Z-2159-2008 | 10% Buffered Formalin Phosphate; Certified For laboratory and manufacturing use only, not... | Thermofisher Scientific Oy | IFP | ||
| Z-2189-2008 | Surgical Table Column Casing Revision B, Product #0788-200-001 Revision B; component of... | STRYKER Communications, Inc. | FQO |