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-0465-2009 | CASMED 500cc Unifusor with aneroid gauge and stopcock valve. Model: 803SGA. It is... | Cas Medical Systems, Inc. | KZD | ||
| Z-0464-2009 | Casmed 500cc Unifusor II with aneroid gauge and thumbwheel valve Model: 2803SGA. It is... | Cas Medical Systems, Inc. | KZD | ||
| Z-0463-2009 | CASMED 500cc Unifusor with aneroid gauge and stopcock valve. Model: A803SGA . The... | Cas Medical Systems, Inc. | KZD | ||
| Z-0462-2009 | CASMED 500cc Unifusor with aneroid gauge and thumbwheel valve Model: 803FGA. It is... | Cas Medical Systems, Inc. | KZD | ||
| Z-0461-2009 | CASMED 500cc Unifusor Classic with piston gauge and thumbwheel valve. Model: 903TGA. It... | Cas Medical Systems, Inc. | KZD | ||
| Z-0610-2009 | Stryker Leibinger New Generation/Universal Mandibular System, Mand. Recon Plate... | Stryker Craniomaxillofacial Division | JEY | ||
| Z-0411-2009 | PALINDROME EMERALD Kit - Cuffed Dual Lumen Catheter with Pre-cuffed Shaft and Heparin... | Medtronic, Inc. | NYU | ||
| Z-0410-2009 | PALINDROME EMERALD Kit - Cuffed Dual Lumen Catheter with Pre-curved Shaft and Heparin... | Medtronic, Inc. | NYU | ||
| Z-0409-2009 | PALINDROME EMERALD SPORT PACK Cuffed Dual Lumen Catheter with Pre-curved Shaft and... | Medtronic, Inc. | NYU | ||
| Z-0327-2009 | Axiom Luminos dRF without ST filter. . Solid state x-ray imager (flat panel/digital... | Siemens Medical Solutions USA, Inc. | MQB | ||
| Z-0326-2009 | Axiom Luminos dRF with ST filter. Solid state x-ray imager (flat panel/digital imager)... | Siemens Medical Solutions USA, Inc. | MQB | ||
| Z-0408-2009 | PALINDROME EMERALD SPORT PACK Cuffed Dual Lumen Catheter with Pre-curved Shaft and... | Medtronic, Inc. | NYU | ||
| Z-2434-2010 | Panorama 0.6T MRI Nuclear Magnetic Resonance Imaging System, Philips Panorama 0.6T Open... | Philips North America LLC | LNH | ||
| Z-2433-2010 | Infinion is Nuclear Magnetic Resonance Imaging. Philips Infinion 1.5T System, Picker... | Philips North America LLC | LNH | ||
| Z-2432-2010 | Polaris, Nuclear Magnetic Resonance Imaging System, Magnet Subsystem, Picker... | Philips North America LLC | LNH | ||
| Z-2431-2010 | Eclipse, Nuclear Magnetic Resonance Imaging system, Magnet Subsystem, Picker... | Philips North America LLC | LNH | ||
| Z-2430-2010 | Vista Nuclear Magnetic Resonance Imaging System, Picker International, Inc. World... | Philips North America LLC | LNH | ||
| Z-2429-2010 | Edge Nuclear Magnetic Resonance Imaging System. "1.5T Edge High-Field Magnetic Resonance... | Philips North America LLC | LNH | ||
| Z-0004-2009 | One Touch Ultra Test Strips, part number 020-994-02, manufactured by LifeScan Inc... | Lifescan, Inc. | NBW | ||
| Z-0339-2009 | TomoTherapy HI-ART Systems with 3.1.2, 3.1.3 or 3.2.1 software. The affected applications... | Accuray Incorporated | IYE | ||
| Z-0192-2009 | Hydrophobic HALO360 Filter that is packaged with HALO360+ Ablation Catheters Model... | Medtronic, Inc. | GEI | ||
| Z-0923-2011 | K-ASSAY Alpha-1 Microglobulin Reagent Kit. Kit contains: 1 vial Reagent 1, Buffer 50 mL... | Kamiya Biomedical Company, LLC | MGA | ||
| Z-2582-2010 | Product is labeled in part: "CP-SM397A-02...Mono-Dox Violet Monofilament Polydioxanone... | C P Medical Inc. | NEW | ||
| Z-0199-2009 | Smallbore T-Port Extension Set with Female Luer Lock Connector and Male Luer Lock T-Port... | B Braun Medical Inc | FPA | ||
| Z-0561-2010 | Xoran MiniCAT System for ENT (server and work station), Xoran Technologies, Ann Arbor... | Xoran Technologies, LLC | JAK | ||
| Z-0195-2009 | GSI Audera (version 2.6 software) Viasys Healthcare, Inc. Part or (Catalog) Numbers... | Medtronic, Inc. | EWO | ||
| Z-0188-2009 | Maquet Alphastar 1132.01AX/BX, 1132.02AX/BX, and 1132.03AX/BX Universal Operating Table | Maquet Cardiovascular Us Sales, LLC | FQO | ||
| Z-1929-2009 | VP 2000 Processor; an automated tissue stainer 100 volt - part 30-144100 or list... | Abbott Molecular, Inc. | KEY | ||
| Z-0022-2009 | BD Visitec High Viscosity Injector, 4mm Ref: 585173. The product is intended for... | Becton Dickinson & Co | HMX | ||
| Z-0542-2009 | Roche ISE Internal Standard Gen.2 for use on Roche cobas c systems, Roche Diagnostics... | Roche Diagnostics GmbH | JIX | ||
| Z-0942-2012 | Vigilance II Monitor Model: VIG2/VIG2E Software: versions 00.51, 00.60, 00.61, 00.62... | Edwards Lifesciences LLC | DXG | ||
| Z-0324-2009 | syngo MultiModality WorkPlace (MM WP). Software product(Model Number 10140720). The... | Siemens Medical Solutions USA, Inc. | LLZ | ||
| Z-0580-2009 | ABBOTT Clinical Chemistry Bilirubin Calibrator, List Number 1E66-04. The device is... | Abbott Medical | JIX | ||
| Z-0318-2009 | Toddler Chair Hip Strap (Belt). The hip belt is made with nylon webbing and a plastic... | Community Products, LLC | INN | ||
| Z-0183-2009 | Bard Vacora Biopsy Vacuum Assisted Biopsy Probe; Catalog numbers VB10118 and VB10140. | Bard Peripheral Vascular Inc | KNW | ||
| Z-0131-2009 | 18 gage XTW needles, sold as a component in SafeSheath Hemostatic Tear-away Introducer... | Merit Medical Systems, Inc. | DYB | ||
| Z-0578-2009 | Custom Waste Management Kit, K10-01756/B, Sterile EO, Merit Medical Systems, Inc., South... | Merit Medical Systems, Inc. | DQO | ||
| Z-0113-2009 | Zilver Expandable Metal Biliary Stent System, ZILBS-10-6, Stent Diameter: 10mm, Stent... | Wilson-Cook Medical Inc. | FGE | ||
| Z-0281-2009 | ASP Automatic Endoscope Reprocessor, AER Plus Product Code 20300 and AER with printer... | Advanced Sterilization Products | FEB | ||
| Z-0100-2009 | M3811B Philips Telemonitoring Clinical Review Software part of Philips Telemonitoring... | Philips North America LLC | DQA | ||
| Z-1375-2012 | Access Immunoassay Systems Assay Protocol File (APF) Software versions for UniCel DxC... | Siemens Healthcare Diagnostics Inc. | JJE | ||
| Z-1374-2012 | Access Immunoassay Systems Assay Protocol File (APF) Software versions for Synchron LXI... | Siemens Healthcare Diagnostics Inc. | JJE | ||
| Z-1373-2012 | Access Immunoassay Systems Assay Protocol File (APF) Software versions for Access... | Siemens Healthcare Diagnostics Inc. | JJE | ||
| Z-1372-2012 | Access Immunoassay Systems Assay Protocol File (APF) Software versions for Access. Part... | Siemens Healthcare Diagnostics Inc. | JJE | ||
| Z-2464-2010 | Philips BV Endura Mobile X-Ray system with the extended rotation option. | Philips North America LLC | JAA | ||
| Z-2463-2010 | Philips BV Pulsera Mobile X-Ray system with the extended rotation option. | Philips North America LLC | JAA | ||
| Z-0224-2009 | Glucose HEX Reagent; HG920-SAM-911. (Clinical chemistry) | Horiba Instruments Incorporated | CFR | ||
| Z-0223-2009 | Glucose (HEX) Hitachi; 3-HG920-L. (Clinical chemistry) | Horiba Instruments Incorporated | CFR | ||
| Z-0222-2009 | Pointe Scientific Liquid Glucose (HEXO) Reagent Set, Pointe Scientific, Inc, Canton, MI... | Horiba Instruments Incorporated | CFR | ||
| Z-0221-2009 | Pointe Scientific Liquid Glucose HEX Reagent Set, Pointe Scientific, Inc, Canton, MI... | Horiba Instruments Incorporated | CFR |