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-1330-2012 | Sorin C5 (perfusion system) The S5 Perfusion System is used to perform, control and... | LivaNova Deutschland GmbH | DTQ | ||
| Z-1329-2012 | Pump control panel. The S5 Perfusion System is used to perform, control and monitor... | LivaNova Deutschland GmbH | DWA | ||
| Z-1328-2012 | Control panel for mast roller pump 85 The S5 Perfusion System is used to perform... | LivaNova Deutschland GmbH | DTQ | ||
| Z-1327-2012 | Control panel for mast roller pump 150/85 The S5 Perfusion System is used to perform... | LivaNova Deutschland GmbH | DTQ | ||
| Z-1326-2012 | S5 Double Roller Pump 85 The S5 Perfusion System is used to perform, control and monitor... | LivaNova Deutschland GmbH | DTQ | ||
| Z-1325-2012 | S5 Single Roller Pump 150 The S5 Perfusion System is used to perform, control and... | LivaNova Deutschland GmbH | DTQ | ||
| Z-1228-2012 | HeartMate II Left Ventricular Assist System (HM II LVAS) Sealed Outflow Graft Bend... | Abbott Medical | DSQ | ||
| Z-1219-2012 | The Brilliance Workspace Portal is a software component of the Computed Tomography X-Ray... | Philips North America LLC | KPS | ||
| Z-1291-2012 | Sarns Soft-Flow Aortic Cannula; Aortic cannula, 7.0 mm (21 Fr) OD with 3/8" connector... | Terumo Cardiovascular Systems Corporation | DWF | ||
| Z-1290-2012 | Sarns Soft-Flow Aortic Cannula; Aortic cannula, 7.0 mm (21 Fr) OD with 3/8" connector... | Terumo Cardiovascular Systems Corporation | DWF | ||
| Z-1289-2012 | Sarns Soft-Flow Aortic Cannula; Aortic cannula, 7.0 mm (21 Fr) OD with 3/8" connector... | Terumo Cardiovascular Systems Corporation | DWF | ||
| Z-1288-2012 | Sarns Soft-Flow Aortic Cannula; Aortic cannula, 7.0 mm (21 Fr) OD with 3/8" connector... | Terumo Cardiovascular Systems Corporation | DWF | ||
| Z-1287-2012 | Sarns Soft-Flow Aortic Cannula; Aortic cannula, 7.0 mm (21 Fr) OD with 3/8" connector... | Terumo Cardiovascular Systems Corporation | DWF | ||
| Z-1069-2015 | Class II | Timberline Cranial Caudal and Posterior Blades, 40 - 180mm Model # 8734-2XXX, 8734-5XXX... | Highridge Medical, LLC | MAX | |
| Z-1506-2012 | Siemens Axiom Sensis XP diagnostic programmable computer Diagnostic programmable computer | Siemens Medical Solutions USA, Inc. | DQK | ||
| Z-1337-2012 | IntelliSpace Portal, M/N 881001, IntelliSpace Portal (ISP) is a multimodality (CT, NM... | Philips North America LLC | KPS | ||
| Z-1474-2012 | Philips eCareManager System, Model 865325, software versions 3.7, 3.7.1 and 3.8... | Visicu, Inc. | MSX | ||
| Z-1817-2012 | Class II | TX1 Tissue Removal System Console. Model: TX1 TX1 Tissue Removal System is an ultrasonic... | Tenex Health | LFL | |
| Z-0268-2013 | Class II | The brand name of the device is AlgiNot, a dental impression material. Product... | Kerr Corporation | ELW | |
| Z-2315-2012 | Class II | Toshiba Ultra-Short Magnetic Resonance Imaging System, EXCELART Vantage... | Canon Medical Systems USA, Inc. | LNH | |
| Z-1340-2012 | RTVue CAM with Corneal Power Measurement, Cornea Power Kit (software) | Optovue Inc. | OBO | ||
| Z-1278-2012 | Permolock C3, Docking system for Power wheelchair in vehicle. Intended use: locking... | Permobil, AB | KNN | ||
| Z-1793-2012 | Class II | Columbus Tibia Plateau (component of the Columbus REVISION Knee System) Product Usage... | Aesculap Inc | JWH | |
| Z-1284-2012 | Talent Captivia Stent Graft System - FreeFlow configurations only. Model numbers affected... | Medtronic, Inc. | MIH | ||
| Z-1359-2012 | OneTouch Verio IQ Blood Glucose Monitoring System Kit; One Touch Verio IQ Blood Glucose... | Lifescan, Inc. | LFR | ||
| Z-1972-2012 | Class II | enFlow IV Fluid Warmer (510k name: EFLOW IV FLUID WARMER, MODEL 100, EFLOW DISPOSABLE... | Vital Signs, Inc. | LGZ | |
| Z-1925-2012 | Class I | FLOW-I Anesthesia System The system is intended for use in administrating anesthesia... | Maquet Cardiovascular Us Sales, LLC | BSZ | |
| Z-1282-2012 | Fildes Enrichment, BBL brand, catalog #211866, in 5 ml tubes,10 tubes/package... | Becton Dickinson & Co | JSC | ||
| Z-1331-2012 | Surgipath Cyto Jar Fixative; a 120 mL clear, leakproof container prefilled with 45 mL of... | Leica Biosystems Richmond, Inc. | LEA | ||
| Z-1177-2012 | Pelton & Crane Spirit 3000 dental operative unit with the TLC SAFEdrive option, 1727... | KaVo Dental Technologies, LLC | EIA | ||
| Z-0524-2013 | Class II | GE Healthcare Carescape Patient Data Module with v2.0 software used with Solar 8000M/l... | GE Healthcare | MHX | |
| Z-1773-2012 | Sterrad Cyclesure 24 Biological Indicator, P/N: 14324 The STERRAD CYCLESURE 24... | Advanced Sterilization Products | FRC | ||
| Z-1433-2012 | Dimension Vista(R) MG Flex(R) Reagent Cartridge The Dimension Vista(R) MG method is an... | Siemens Healthcare Diagnostics Inc. | JGJ | ||
| Z-1285-2012 | Whole body Computed Tomography X-Ray System (Brilliance 64 and Ingenuity CT), Brilliance... | Philips North America LLC | JAK | ||
| Z-1383-2012 | Siemens Axiom Luminos dRF solid state x-ray imager Solid state x-ray imager (flat... | Siemens Medical Solutions USA, Inc. | MQB | ||
| Z-1334-2012 | Oridion CO2 sampling lines and water traps under the label: Omnistream CO2 Sampling... | Oridion Medical 1987 Ltd. | CCK | ||
| Z-1333-2012 | Oridion CO2 sampling lines and water traps under the label: Surestream CO2 Sampling... | Oridion Medical 1987 Ltd. | CCK | ||
| Z-1332-2012 | Oridion CO2 sampling lines and water traps under the label: MicroStreamC02 Sampling... | Oridion Medical 1987 Ltd. | CCK | ||
| Z-1315-2012 | QRS Diagnostic Universal ECG 12 Channel ECG (IEC), Rx only, REF Z-7000-0400, Manufactured... | VectraCor, Inc. | LOS | ||
| Z-1227-2012 | Covidien Duet TRS Articulating 60- 3.5MM, Single Use Loading Unit Ref: DUET6035A The... | Medtronic, Inc. | GDW | ||
| Z-1268-2012 | Siemens ADVIA Centaur Vitamin D Diluent 2-pack, Reference 10494100 in vitro diagnostic... | Siemens Healthcare Diagnostics Inc. | MRG | ||
| Z-1158-2012 | SORIN C5 CONSOLE Part No.: 58-00-00, SORIN GROUP DEUTSCHLAND GMBH Lindberghstrasse 25... | LivaNova USA, Inc. | DTQ | ||
| Z-1157-2012 | SORIN GROUP, Distributed by: Sorin Group USA, Inc., Arvada, CO 80004, USA, SDR S5 MAST... | LivaNova USA, Inc. | DTQ | ||
| Z-1156-2012 | SORIN GROUP, Distributed by: Sorin Group USA, Inc., Arvada, CO 80004, USA, S5 TWO MAST... | LivaNova USA, Inc. | DTQ | ||
| Z-1155-2012 | SORIN GROUP, Distributed by: Sorin Group USA, Inc., Arvada, CO 80004, USA, SRD S5 TWO... | LivaNova USA, Inc. | DTQ | ||
| Z-1154-2012 | SORIN GROUP, Distributed by: Sorin Group USA, Inc., Arvada, CO 80004, USA, SRD S5 MAST... | LivaNova USA, Inc. | DTQ | ||
| Z-1153-2012 | S5/C5 Control panel for 2 mast roller pumps 85, Part No.: 28-95-85, Sorin Group... | LivaNova USA, Inc. | DTQ | ||
| Z-1152-2012 | S5/C5 control panel for mast roller pump 150/85, Part No.: 28-95-80, Sorin Group... | LivaNova USA, Inc. | DTQ | ||
| Z-1151-2012 | Stockert S5 Control and display module, Part No.: 28-95-10, Sorin Group Deutschland GMBH... | LivaNova USA, Inc. | DTQ | ||
| Z-1150-2012 | Stockert, S5 Double roller pump 85, Part 10-85-00, Sorin Group Deutschland GMBH... | LivaNova USA, Inc. | DTQ |