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-2324-2009 | Sensititre Mueller-Hinton Broth w/Lysed Horse Blood (MHB w/LHB), Model Number: CP112-10... | Trek Diagnostic Systems, Ltd. | JTZ | ||
| Z-2226-2009 | Applied Medical 15x100mm Kii Optical Access System, Non-Threaded 6/Box, Model Number... | Applied Medical Resources Corp | GCJ | ||
| Z-0320-2011 | Straumann T-Sleeve 2.8mm, height 6mm, guided Article Number: 034.055V46 Intended for use... | Straumann USA, LLC | NDP | ||
| Z-2274-2012 | Class II | Apelo Modular Screwdriver labeled in part: "APELO PEDICLE SCREW SYSTEM***Modular... | Atlas Spine, Inc. | NKB | |
| Z-1323-2010 | The Bigger Better-Bladder, Catalog Number BBB38 (with 3/8 inch ID tubing), Sterile... | Circulatory Technology, Inc. | DTN | ||
| Z-1320-2010 | ThermoFisher Scientific Microm STP 420D automated tissue processor. | Thermo Fisher Scientific Oy | IEO | ||
| Z-3091-2011 | Software version 3.3 for Rapid Programmer devices, Model 3832. Software version 3.3 for... | Abbott Medical | LGW | ||
| Z-1928-2009 | AMPLILINK Software, version 3.1.0 to 3.2.2 with COBAS AmpliPrep. Catalog number... | Roche Molecular Systems Inc | JJH | ||
| Z-1316-2013 | Class II | Loop, Cutting, Angled 22FR (26055G/6). Resectoscope accessories (ie. electrode, cutting... | Karl Storz Endoscopy-America, Inc. | FJL | |
| Z-1315-2013 | Class II | Electrode, Cutting, 24FR, 0.30MM (27040G-.30/6). Resectoscope accessories (ie... | Karl Storz Endoscopy-America, Inc. | FJL | |
| Z-1314-2013 | Class II | Knife, Cold, Straight (27068K/6). Resectoscope accessories (ie. electrode, cutting loops... | Karl Storz Endoscopy-America, Inc. | FJL | |
| Z-1313-2013 | Class II | Loop, Cutting, 24FR (26050G/6). Resectoscope accessories (ie. electrode, cutting loops... | Karl Storz Endoscopy-America, Inc. | FJL | |
| Z-1312-2013 | Class II | Electrode, VaporCut, 24FR (27050SG/6). Resectoscope accessories (ie. electrode, cutting... | Karl Storz Endoscopy-America, Inc. | FJL | |
| Z-1311-2013 | Class II | Electrode, Roller, Vaporization, 24FR (27050RK/6). Resectoscope accessories (ie... | Karl Storz Endoscopy-America, Inc. | FJL | |
| Z-1310-2013 | Class II | Electrode, Barrel Bar, 24FR (27050NX/6). Resectoscope accessories (ie. electrode... | Karl Storz Endoscopy-America, Inc. | FJL | |
| Z-1309-2013 | Class II | Electrode, Roller Ball, 24FR (27050NK/6). Resectoscope accessories (ie. electrode... | Karl Storz Endoscopy-America, Inc. | FJL | |
| Z-1308-2013 | Class II | Electrode, Coag, Ball End, 24FR (27050N/6). Resectoscope accessories (ie. electrode... | Karl Storz Endoscopy-America, Inc. | FJL | |
| Z-1307-2013 | Class II | Electrode, Coag, Pointed, 24FR (27050L/6). Resectoscope accessories (ie. electrode... | Karl Storz Endoscopy-America, Inc. | FJL | |
| Z-1306-2013 | Class II | Electrode, cutting, 24FR (27050G-.30/6). Resectoscope accessories (ie. electrode... | Karl Storz Endoscopy-America, Inc. | FJL | |
| Z-1305-2013 | Class II | Electrode, cutting, 24FR (27050G/6). Resectoscope accessories (ie. electrode, cutting... | Karl Storz Endoscopy-America, Inc. | FJL | |
| Z-1650-2009 | syngo Imaging Version V31 Picture Archiving and Communication System, model number... | Siemens Medical Solutions USA, Inc. | LLZ | ||
| Z-1204-2012 | The Reprocessed Mitek Arthroscopic Wand is considered a soft tissue ablators. Soft tissue... | Stryker Sustainability Solutions | GEI | ||
| Z-1729-2009 | Clinac with Version 7.x Software, manufactured by Varian Medical Systems, Palo Alto... | Varian Medical Systems, Inc. | IYE | ||
| Z-1675-2009 | Somatom Definition Model AS/AS+, Model number 8098027. Intended use: Computed... | Siemens Medical Solutions USA, Inc. | JAK | ||
| Z-1993-2009 | Tibial Tray, component of Ortho Development Balanced Knee System, Nonporous, Sterile R... | Ortho Development Corp. | JWH | ||
| Z-1617-2009 | Zimmer Kinectivo Technology Modular Neck, BB, 12/14 neck taper, sterile, Zimmer, Warsaw... | Zimmer GmbH | LPH | ||
| Z-1616-2009 | Zimmer Alumina Ceramic Femoral Head, 12/14 taper, 32 mm diameter, neck length 0 mm... | Zimmer GmbH | LZO | ||
| Z-1596-2009 | Stat (TM) Super-Fine (TM) Pen Needles and Allison Medical, Inc. Sure Comfort Pen Needles... | Stat Medical Devices, Inc. | FMI | ||
| Z-1724-2009 | Amvex Integrated Flowmeter; a nonback-pressure compensated Bourdon gauge flowmeter; Amvex... | Amvex Corporation | CCN | ||
| Z-0370-2010 | Zimmer Dynesys top-loading cutter, spacer, Zimmer Spine, Minneapolis, MN; REF... | Zimmer GmbH | NQP | ||
| Z-0029-2013 | Class II | Triage TOX Drug Screen Panel, Model# 94400. Product Usage: The Triage TOX Drug Screen... | Alere San Diego, Inc. | DJR | |
| Z-2078-2009 | DYONICS 25 Fluid Management System Disposable Inflow/Outflow Tubeset With Forked Suction... | Smith & Nephew, Inc. | HRX | ||
| Z-2077-2009 | DYONICS 25 Fluid Management System Disposable Inflow/Outflow Tubeset With Single Suction... | Smith & Nephew, Inc. | HRX | ||
| Z-0590-2010 | Hocoma Lokomat-System with Pediatric Module Software Versions: V4.30, V4.31, V4.31a... | Hocoma AG | BXB | ||
| Z-0549-2011 | ALLURA XPER FD20/10 The intended uses of the Allura XPER X-ray systems involved with this... | Philips North America LLC | IZI | ||
| Z-0548-2011 | ALLURA XPER FD20 The intended uses of the Allura XPER X-ray systems involved with this... | Philips North America LLC | IZI | ||
| Z-0547-2011 | ALLURA XPER FD10/10 The intended uses of the Allura XPER X-ray systems involved with this... | Philips North America LLC | IZI | ||
| Z-0546-2011 | Allura XPER FD10 F/C The intended uses of the Allura XPER X-ray systems involved with... | Philips North America LLC | IZI | ||
| Z-0545-2011 | Allura XPER X-ray system. The intended uses of the Allura XPER X-ray systems involved... | Philips North America LLC | IZI | ||
| Z-0544-2011 | MultiDiagnost Eleva with FD. The Philips MultiDiagnost Eleva intended use is for the... | Philips North America LLC | IZI | ||
| Z-1937-2009 | EASYMax N. Self-Monitoring Blood Glucose System, distributed in cardboard carton kits... | Oak Tree International Holdings, Inc. | NBW | ||
| Z-1177-2010 | Toshiba America Medical Systems Inc (TAMS) Digital Radiography System Radrex-i... | Canon Medical Systems USA, Inc. | MQB | ||
| Z-1655-2009 | Blackstone Medical: ICON Modular Pedicle Screw System; P/N's 54-9011 (implant set)... | Blackstone Medical, Inc. | MNI | ||
| Z-1602-2010 | Polarus(R) Humeral Fixation System, size: 3.5mm x 25.0mm Cortical Screw, QTY 1, Ref... | Acumed LLC | HWC | ||
| Z-0413-2010 | Merit Medical Systems, Inc., Convenience Trays, custom packaged under the following Merit... | Merit Medical Systems, Inc. | KDD | ||
| Z-1022-2011 | PEAK brand PlasmaBlade EXT, Tissue Dissection Device, Catalogue Number... | Peak Surgical, Inc. | GEI | ||
| Z-1869-2009 | Maquet Coronary Perfusion Cannulae with Balloon Tip, with either self-inflating balloon... | Maquet Cardiovascular LLC | DWF | ||
| Z-1531-2009 | Biomet OSS Elliptical Proximal Femoral Trial 7 cm left provisional, stainless steel... | Zimmer GmbH | KRO | ||
| Z-1530-2009 | Biomet OSS Elliptical Proximal Femoral Trial 7 cm, right provisional, stainless steel... | Zimmer GmbH | KRO | ||
| Z-1529-2009 | Biomet OSS Letson Proximal Femoral Trial 7 cm resection/left, stainless steel, Biomet... | Zimmer GmbH | KRO |