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-0938-2009 | VOYAGER NC Coronary Dilatation Catheter, 4.5 X 8.0 mm. The device is used for in the... | Abbott Vascular | MAF | ||
| Z-0608-2009 | Hitachi CXR4 Computed Tomography Scanner. This product is an x-ray imaging device that... | FUJIFILM Healthcare Americas Corporation | JAK | ||
| Z-0503-2009 | Maxi Move, Model NDA0200-20 Batteries Pack; BHM Medical Inc., 2001 Tanguay, Magog, QC... | Arjo, Inc. | FSA | ||
| Z-2166-2011 | DigiView software release 3.4.4.4 through 3.5.5.2. , 2008 Digisonics, Inc... | Digisonics, Inc | LLZ | ||
| Z-1036-2009 | GE Innova 4100/4100 IQ. , GE Healthcare, Waukesha, WI 53188 ( The system consists of an a... | GE Healthcare | MQB | ||
| Z-1204-2009 | diaDexus Inc. PLAC Test Reagent Kit, Turbidimetric Immunoassay for the Quantitative... | Diadexus, Inc. | NOE | ||
| Z-1723-2009 | Signa Openspeed 0.7T MR Systems, Model Numbers: Openspeed 3 (2138300-30), Openspeed 4... | GE Healthcare | LNH | ||
| Z-1722-2009 | GE Healthcare Signa Ovation 0.35T, Model Numbers: Ovation 1-3 (2276937), Ovation 4... | GE Healthcare | LNH | ||
| Z-2219-2009 | GE Healthcare Ventri, GE Healthcare, Waukesha, WI. Model number(s): H3000YW, H3000YY... | GE Healthcare | KPS | ||
| Z-1172-2009 | Medtronic RV Lead Integrity Alert , Cat. # SW012, 1.0 software in EnTrust(R) (D153ATG... | Medtronic, Inc. | LWS | ||
| Z-0491-2010 | Zodiac Polyaxial Spinal Fixation System. A spinal interlaminal fixation orthosis is a... | Alphatec Spine, Inc. | KWP | ||
| Z-1091-2009 | Glucose Oxidase Reagent as follows: Pointe Scientific Glucose Oxidase Reagent Set... | Horiba Instruments Incorporated | CGA | ||
| Z-1196-2009 | Abbott brand FreeStyle Navigator, Receiver Warranty Kit, Blood Glucose Monitoring System... | Abbott Medical | MDS | ||
| Z-1073-2009 | Dual Taper Wedge Pressed Fit Femoral Component. The Dual Taper Wedge is a single use... | Globus Medical, Inc. | LWJ | ||
| Z-1017-2009 | Medtronic TSRH Spinal System, 3Dx Splined Connector, Large; Medtronic Sofamor Danek... | Warsaw Orthopedic, Inc. | MNI | ||
| Z-1016-2009 | Medtronic TSRH Spinal System, 3Dx Splined Connector, Medium; Medtronic Sofamor Danek... | Warsaw Orthopedic, Inc. | MNI | ||
| Z-1015-2009 | Medtronic TSRH Spinal System, 3Dx Splined Connector, Small; Medtronic Sofamor Danek... | Warsaw Orthopedic, Inc. | MNI | ||
| Z-1014-2009 | Medtronic TSRH 3DX Implant Set; SPS002058. Sets are unlabeled, but contain individually... | Warsaw Orthopedic, Inc. | MNI | ||
| Z-1635-2009 | Datex-Ohmeda S/5 Anesthesia Delivery Unit Intended to provide general inhalation... | GE Healthcare | BSZ | ||
| Z-1634-2009 | Datex-Ohmeda AS/3 Anesthesia Delivery Unit An Anesthesia Gas Machine for composition... | GE Healthcare | BSZ | ||
| Z-1633-2009 | GE Datex-Ohmeda ADU Carestation Intended to provide general inhalation anesthesia and... | GE Healthcare | BSZ | ||
| Z-0617-2009 | DeVilbiss Model 515A Oxygen Concentrator Intended to provide supplemental low flow... | Sunrise Medical, Inc. | CAW | ||
| Z-0856-2009 | RoboCouch Patient Support System, a component of the CyberKnife Robotic Radiosurgery... | Accuray Incorporated | JAI | ||
| Z-0599-2009 | Alimed Gait Belt (Transfer Aid) Antimicrobial Plastic Buckle, 70" Model: 72109 | Alimed, LLC | IKX | ||
| Z-0598-2009 | Alimed Gait Belt (Transfer Aid), Antimicrobial Plastic buckle, 54" Model: 72108 | Alimed, LLC | IKX | ||
| Z-0325-2009 | FS-OMNI, Fusion Omni-Tome, Sterile, Rx only, Wilson Cook Medical, GI Endoscopy, 4900... | Wilson-Cook Medical Inc. | KNS | ||
| Z-0413-2009 | Arjo Maxi 500 Patient Lift with Manual 4-Point DPS (Dynamic Positioning System) and... | Arjo, Inc. | FSA | ||
| Z-0412-2009 | Arjo Maxi 500 Patient Lift with 2-Point Spreader Bar and Scale. A Non-AC-Powered Patient... | Arjo, Inc. | FSA | ||
| Z-0568-2010 | Paramed Polypropylene evacuation sled for non-ambulatory patients. Hand-carried... | Paramed Systems | FPP | ||
| Z-0343-2009 | AMO Healon D Ophthalmic Viscosurgical Device, Product Code: 10204011, Lot Number... | Advanced Medical Optics, Inc. | LZP | ||
| Z-0537-2010 | Otto Bock Modular Knee Joint, 3R66, Otto Bock HealthCare GmbH, Max-Nader-StraBe 15... | Bock,Otto,Orthopedic Ind,Inc | ISY | ||
| Z-0992-2009 | Bone Wax. Ethicon, Inc. Bone wax is available sterile in individual foil envelopes... | Ethicon, Inc | MTJ | ||
| Z-2076-2017 | Class II | Navitrack System - OS Knee Universal, Stereotaxic instrument | Zimmer CAS | HAW | |
| Z-1885-2009 | IntelePACS Picture Archiving Communications System InteleViewer module, Model #3.X.X. | Intelerad Medical Systems Incorporated | LLZ | ||
| Z-1884-2009 | IntelePACS Picture Archiving Communications System InteleViewer Workstation Model #3.X.X. | Intelerad Medical Systems Incorporated | LLZ | ||
| Z-0955-2009 | Meter Remote for OneTouch Ping Glucose Management System | Animas Corp. | LZG | ||
| Z-0863-2009 | DeVilbiss Model 7310PR-D VacuAide Compact Suction Unit. A portable, AC-powered or... | Sunrise Medical, Inc. | JCX | ||
| Z-2221-2009 | ACCELERATOR APS System Input/Output Module (IOM); List Number: 7L01-01; manufactured by... | Abbott Medical | JQP | ||
| Z-0512-2009 | Stryker Custom Cranial Implant Kit, extra large. Distributed by Stryker... | Stryker Craniomaxillofacial Division | KKY | ||
| Z-0511-2009 | Stryker Custom Cranial Implant Kit, large. Distributed by Stryker Craniomaxillofacial... | Stryker Craniomaxillofacial Division | KKY | ||
| Z-0510-2009 | Stryker Custom Cranial Implant Kit, medium. Distributed by Stryker Craniomaxillofacial... | Stryker Craniomaxillofacial Division | KKY | ||
| Z-0509-2009 | Stryker Custom Cranial Implant Kit, small. Distributed by Stryker Craniomaxillofacial... | Stryker Craniomaxillofacial Division | KKY | ||
| Z-0415-2009 | Fredrick's Converse Retractor #5 F/O, Model Number: 01-0485. A fiber optic retractor... | Biomet Microfixation | FDG | ||
| Z-0496-2009 | Thoratec Heartmate II Left Ventricular Assist System (LVAS). Model/Catalog Number 1355... | Abbott Medical | DSQ | ||
| Z-1134-2010 | Leksell GammaPlan. Leksell GammaPlan is designed for use with the Leksell Gamma Knife... | Elekta Limited | IWB | ||
| Z-0927-2009 | Artiste MV SA Linear Accelerator with syngo RT Therapist Version 4.1 build 67 and build... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-0857-2009 | Artiste MV Digital Linear Accelerator, when used in combination with Syngo RT Therapist... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-2477-2010 | Philips Integris Allura Flat Detector 9C Angiographic X-ray system. This system with... | Philips North America LLC | IZI | ||
| Z-2476-2010 | Philips Allura XPER FD20 Angiographic X-ray system. This system with Velara Generator... | Philips North America LLC | IZI | ||
| Z-2475-2010 | Philips Allura XPER FD 20/10 Angiographic X-ray system. This system with Velara... | Philips North America LLC | IZI |