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-0956-2011 | Stockert, S5 Roller Pump 150, Part No.: 10-80-00, Sorin Group Deutschland Gmbh... | LivaNova USA, Inc. | DTQ | ||
| Z-0789-2011 | ev3 NanoCross 0.14 OTW PTA Dilatation Catheter, sterilized using ethylene oxide gas. REF... | Medtronic, Inc. | DQY | ||
| Z-1945-2011 | Access Free T4 Calibrator, Part Number: 33885, Lot Numbers: 014769 The Access Free T4... | Siemens Healthcare Diagnostics Inc. | CEC | ||
| Z-0807-2011 | ACL ELITE PRO Coagulation Analyzer, PN 00001000311 Coagulation testing. | Instrumentation Laboratory Co. | JPA | ||
| Z-0806-2011 | ACL ELITE Coagulation Analyzer, PN 00000880311 Coagulation testing. | Instrumentation Laboratory Co. | JPA | ||
| Z-0805-2011 | ACL 10000 Coagulation Analyzer, PN 0000100011 Coagulation testing. | Instrumentation Laboratory Co. | JPA | ||
| Z-0804-2011 | ACL 9000 Coagulation Analyzer, PN 00000990011 Coagulation testing. | Instrumentation Laboratory Co. | JPA | ||
| Z-0803-2011 | ACL 8000 Coagulation Analyzer, PN 00000880011 Coagulation testing. | Instrumentation Laboratory Co. | JPA | ||
| Z-1012-2011 | Arrow WH-02220 - Epidural Catheterization Kit with FlexTip Plus(R) Catheter Intended use... | Arrow International LLC (subsidiary of Teleflex Incorporated) | CAZ | ||
| Z-0832-2011 | Urethral Warmer System Model number FPRCH3001 The Urethral Warming System is designed... | Galil Medical Ltd. | GEH | ||
| Z-1420-2011 | Stryker Navigation System - SALES DEMO, Part number 81-81018. It provides precise... | Stryker Corp. | HAW | ||
| Z-1419-2011 | Stryker Navigation System - SALES DEMO, Part number 81-81016. provides precise... | Stryker Corp. | HAW | ||
| Z-1418-2011 | Stryker Navigation System - SpineMap(TM) 3D - Sales Demo SOFTWARE, Part number 81-80045... | Stryker Corp. | HAW | ||
| Z-1417-2011 | Stryker Navigation System - OrthoMap 3D (Sales Demos), Part number 81-81016. It provides... | Stryker Corp. | HAW | ||
| Z-1416-2011 | Stryker Navigation System - OrthoMap 3D - Planning, Part number 6005-651-000. It... | Stryker Corp. | HAW | ||
| Z-1415-2011 | Stryker Navigation System - OrthoMap 3D - Enable, Part number 6005-650-300. It provides... | Stryker Corp. | HAW | ||
| Z-1414-2011 | Stryker Navigation System - OrthoMap 3D Module, Part number 6005-650-000. It provides... | Stryker Corp. | HAW | ||
| Z-1413-2011 | Stryker Navigation System - SpineMap 3D - Planning, Part number 6002-651-000. It... | Stryker Corp. | HAW | ||
| Z-1412-2011 | Stryker Navigation System - OrthoMap 3D - Enable, Part number 6002-650-300. It provides... | Stryker Corp. | HAW | ||
| Z-1411-2011 | Stryker Navigation System - SpineMap 3D - Upgrade, Part number 6002-650-100. It provides... | Stryker Corp. | HAW | ||
| Z-1410-2011 | Stryker Navigation System - SpineMap 3D Module, Part number 6002-650-000. It provides... | Stryker Corp. | HAW | ||
| Z-1409-2011 | Stryker Navigation System - iNtellect Cranial Planning Software - Enable, Part number... | Stryker Corp. | HAW | ||
| Z-1408-2011 | Stryker Navigation System - iNtellect Cranial Navigation/Planning Software, Part number... | Stryker Corp. | HAW | ||
| Z-1407-2011 | Stryker Navigation System - iNtellect Cranial Navigation Software - Enable, Part number... | Stryker Corp. | HAW | ||
| Z-1406-2011 | Stryker Navigation System - iNtellect Cranial Software - Maintenance, Part number... | Stryker Corp. | HAW | ||
| Z-1405-2011 | Stryker Navigation System - iNtellect Cranial Software - Upgrade, Part number... | Stryker Corp. | HAW | ||
| Z-1404-2011 | Stryker Navigation System - iNtellect Cranial Software, Part number 6000-651-000. It is... | Stryker Corp. | HAW | ||
| Z-1403-2011 | Stryker Navigation System - iNtellect Cranial Navigation/Planning Software, Part number... | Stryker Corp. | HAW | ||
| Z-1402-2011 | Stryker Navigation System - iNtellect Cranial Software, Part number 6000-650-000. It is... | Stryker Corp. | HAW | ||
| Z-0828-2011 | CLP Instrumentation Removal Hook, distributed by DJO Surgical, manufactured by Encore... | Encore Medical, LP | HWB | ||
| Z-0711-2011 | Genzyme Diagnostics Total Serum Cholesterol Kit, IVD Catalog Number: 225-26 Intended... | Sekisui Diagnostics P.E.I. Inc. | CHH | ||
| Z-0617-2011 | The PercuNav MP008R-B Button Probe is designed to be used with Philips (formerly Traxtal)... | Philips North America LLC | JAK | ||
| Z-3128-2011 | Inhibin A ELISA, Part Number: DSL-10-28100-4 Product Usage: The Inhibin A ELISA kit is... | Siemens Healthcare Diagnostics Inc. | NDR | ||
| Z-2562-2011 | Focal Radiation Treatment Planning Workstation. Focal Release 4.51.00 and above. Allows... | Elekta Limited | MUJ | ||
| Z-1433-2011 | 10) Brivo MR355/Optima MR360 Not yet 510(K) cleared and are not distributed in the US... | GE Healthcare | LNH | ||
| Z-1432-2011 | 9) Signa Excite 1.5 T (Excite II) (K013636 Signa Infinity MR System with EXCITE... | GE Healthcare | LNH | ||
| Z-1431-2011 | 8) Signa 3.0T Infinity with EXCITE (K030874 GE 3.0T Signa Infinity TwinSpeed with EXCITE... | GE Healthcare | LNH | ||
| Z-1430-2011 | 7) Signa OpenSpeed (K032795 GE 0.7T Signa OpenSpeed with EXCITE MR System) The... | GE Healthcare | LNH | ||
| Z-1429-2011 | 6) Signa Excite (K041476 Signa Excite 1.5T and 3.0T) Signa Excite, 12x (K041476 Signa... | GE Healthcare | LNH | ||
| Z-1428-2011 | 5) Signa HDx (K052293 Signa HDx and HDxt MR Systems) Signa HDx or Signa HDxt... | GE Healthcare | LNH | ||
| Z-1427-2011 | 4) Signa HDe (K052978 GE 1.5T Signa HDe MR System) The GE Signa HDe MR system is a... | GE Healthcare | LNH | ||
| Z-1426-2011 | 3) Signa Advantage (K911959 Signa Advantage MR System) A magnetic resonance... | GE Healthcare | LNH | ||
| Z-1425-2011 | 2) Signa Advantage SP (K942604 Signa Advantage SP MR System) A magnetic resonance... | GE Healthcare | LNH | ||
| Z-1472-2011 | Veridex, Cell Search Circulating Tumor Cell Control Kit. Product code 7900003 | Veridex, LLC | NRS | ||
| Z-0898-2011 | Arrow-Howes (TM) Multi Lumen Central Venous Catheterization Set with Blue FlexTip(R)... | Arrow International LLC (subsidiary of Teleflex Incorporated) | DQY | ||
| Z-1424-2011 | 1) Signa Lx ( K962061 Signa Horizon Cx) The Signa Horizon Cx System is... | GE Healthcare | LNH | ||
| Z-0814-2011 | ThomoTherapy Hi-Art System Intended to be used as an integrated system for the planning... | Accuray Incorporated | MUJ | ||
| Z-0833-2011 | Care E Vac 3 Portable Suction; Battery/AC Portable Aspirator; Ohio Medical Corporation... | Ohio Medical LLC | BTA | ||
| Z-0836-2012 | Package of center-drive bone screws labeled in part: "***REF: 01-7204***1.5MM" SYSTEM... | Biomet Microfixation | NDJ | ||
| Z-0835-2012 | Package of cross-drive bone screws labeled in part: "***REF #95-1504***"1.5MM" SYSTEM... | Biomet Microfixation | NDJ |