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-0624-2011 | Cmax Surgical Tables, Model #'s: Cmax110, Cmax 220 manufactured by Steris Corporation in... | STERIS Corporation | FQO | ||
| Z-2633-2010 | Gemstar Pump Set with Convertible Pin, Latex-Free set with Attached Pressure-Activated... | Abbott Medical | FPA | ||
| Z-2632-2010 | Gemstar Pump Set, LifeShield Latex-Free Pump Set with Orange Polyethylene-Lined Light... | Abbott Medical | FPA | ||
| Z-2631-2010 | Gemstar Pump Set, LifeShield Latex-Free Pump Set with Check Valve, Clave Ports, P.A.V... | Abbott Medical | FPA | ||
| Z-2630-2010 | Gemstar Pump Set-SL, Latex-Free Set with Attached Pressure-Activated Anti-Siphon Valve... | Abbott Medical | FPA | ||
| Z-2629-2010 | Gemstar Pump Set-SL, Latex-Free Extension Set with Integral Pressure-Activated... | Abbott Medical | FPA | ||
| Z-2628-2010 | Gemstar Pump Set, Latex-Free Extension Set with Integral Pressure-Activated Anti-Siphon... | Abbott Medical | FPA | ||
| Z-2627-2010 | Gemstar Pump Set, Latex-Free Extension Set with Integral Pressure-Activated Anti-Siphon... | Abbott Medical | FPA | ||
| Z-0028-2012 | Coulter PrepPlus 2, Part Number: 378600, Serial Numbers: 1001008698, 1001008699, and... | Siemens Healthcare Diagnostics Inc. | JQW | ||
| Z-2326-2012 | Class II | Polar Dressing, Knee/MU/Shldr Intelli-Flo-Breg, PN 10630 Used with cold therapy pads to... | Breg Inc | KGX | |
| Z-2657-2010 | AVI Sterile Impad Rigid Sole Foot Cover, Left Foot Product Code:6067 | Medtronic, Inc. | JOW | ||
| Z-2656-2010 | AVI Sterile Impad Rigid Sole Foot Cover, Right Foot Product Code:6066 | Medtronic, Inc. | JOW | ||
| Z-2285-2010 | Suros ATEC 0912-20 Breast Biopsy and Excision System Handpiece, REF ATEC0912-12, sterile... | Hologic, Inc. | KNW | ||
| Z-2354-2010 | Titan 3 5K Low-Speed Motor - Star Titan 3, 5,000 rpm- Lube Free | Dentalez, Inc., Stardental Division | EFA | ||
| Z-0513-2013 | Class II | DPM 6/7 Patient Monitor Manufactured in China for : Mindray DS USA, Inc. 800 MacArthur... | Datascope Corp. | MHX | |
| Z-3103-2011 | BrachyVision, versions 8.2, 8.5, 8.6 and 8.9. Varian Medical Systems. 3100 Hansen Way... | Varian Medical Systems, Inc. | MUJ | ||
| Z-1619-2011 | GLU Reagent (GLU cartridge assay) used on Synchron LX and UniCel DxC Synchron Clinical... | Siemens Healthcare Diagnostics Inc. | CEM | ||
| Z-0020-2011 | HydraGlide Silicone Chest Tube Catheter, 32 Fr Straight Product Code 14132 | Atrium Medical Corporation | GBS | ||
| Z-0019-2011 | HydraGlide Silicone Chest Tube Catheter, 24 Fr Straight Product Code 14124 | Atrium Medical Corporation | GBS | ||
| Z-2627-2011 | BACTEC" FX Instrument-Top, catalog #441385. The BD BACTEC" FX instrument is designed... | Becton Dickinson & Co | MDB | ||
| Z-2626-2011 | BACTEC" FX System Software, catalog #441398 and #441750 The BD BACTEC" FX instrument is... | Becton Dickinson & Co | MDB | ||
| Z-2607-2010 | IGFBP-3 Immunoradiometric Assay (IRMA) Kit, Part Number: DSL-6600 usage: The DSL6600... | Siemens Healthcare Diagnostics Inc. | CFL | ||
| Z-2486-2010 | Sterile single/double breast personal accessory convenience kit for the Lactina Breast... | Medela AG | HGX | ||
| Z-2485-2010 | Sterile single/double breast personal accessory convenience kit for single or double... | Medela AG | HGX | ||
| Z-2484-2010 | Sterile double breast personal accessory convenience kit for the Symphony or Lactina... | Medela AG | HGX | ||
| Z-2483-2010 | Sterile double breast personal accessory convenience kit for the Symphony Breast pump... | Medela AG | HGX | ||
| Z-2651-2010 | GYRUS ACMI, dissector PlasmaKnife" , REF 7035-3005, Rx only, STERILE R, CE 0344... | Gyrus ACMI, Inc. | GEI | ||
| Z-2503-2010 | GATOR. REF 9263A, 4.2mm STERLING, STERILE Rx Only. | Linvatec Corporation | GFA | ||
| Z-0002-2011 | Baxter Colleague Triple Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation... | Baxter Healthcare Corporation | FRN | ||
| Z-0001-2011 | Baxter Colleague Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation... | Baxter Healthcare Corporation | FRN | ||
| Z-0194-2013 | Class III | Boule Con-Diff Hematology Control 9 vials. For in vitro diagnostic use as a control to... | Clinical Diagnostic Solutions, Inc. | JPK | |
| Z-0193-2013 | Class III | Boule Con Diff US Tri Pack, 6 Vials. For in vitro diagnostic use as a control to monitor... | Clinical Diagnostic Solutions, Inc. | JPK | |
| Z-2436-2010 | The Gyrus ACMI Pleatman Sac Tissue Removal System facilitates removal of specimens while... | Gyrus ACMI, Inc. | GCJ | ||
| Z-0930-2011 | i-STAT G3+ Cartridge; pH, pCO2, PO2; IVD Abbott Point of Care The test for PCO2, as part... | Abbott Medical | CHL | ||
| Z-0929-2011 | i-STAT CG8+ Cartridge; pH, pCO2, PO2, NA, K, iCa, Glu, Hct; IVD Abbott Point of Care The... | Abbott Medical | CHL | ||
| Z-1020-2011 | i-STAT Level 2 Control Value Assignment Sheets Human Consumption | Abbott Medical | JJY | ||
| Z-0059-2011 | Closed knot pusher REF 902813, Biomet Sports Medicine, Warsaw, IN. The device is... | Zimmer GmbH | HXO | ||
| Z-2589-2010 | Apligraf is supplied as a living, bi-layered skin substitute. Article Number... | Organogenesis, Inc. | MGR | ||
| Z-1059-2011 | Omnifit PSL M/S 3-Hole Cup, 58MM; Stryker Orthopaedics, Uses in primary and revision... | Howmedica Osteonics Corp | MEH | ||
| Z-1058-2011 | Omnifit PSL M/S 3-Hole Cup, 54MM; Stryker Orthopaedics, Uses in primary and revision... | Howmedica Osteonics Corp | MEH | ||
| Z-1057-2011 | Omnifit PSL M/S 3-Hole Cup, 50MM; Stryker Orthopaedics, Uses in primary and revision... | Howmedica Osteonics Corp | MEH | ||
| Z-1056-2011 | Omnifit PSL M/S 3-Hole Cup, 48MM; Stryker Orthopaedics, Uses in primary and revision... | Howmedica Osteonics Corp | MEH | ||
| Z-1055-2011 | Omnifit PSL M/S 3-Hole Cup, 46MM; Stryker Orthopaedics, Uses in primary and revision... | Howmedica Osteonics Corp | MEH | ||
| Z-1054-2011 | Omnifit M/S Dual Geom Shell 58 MM; Stryker Orthopaedics, Uses in primary and revision... | Howmedica Osteonics Corp | MEH | ||
| Z-1053-2011 | Omnifit M/S PSL Shell 58 MM; Stryker Orthopaedics, Uses in primary and revision total... | Howmedica Osteonics Corp | MEH | ||
| Z-1052-2011 | Omnifit M/S PSL Porous Coated Acetabular Shell 54MM; Stryker Orthopaedics, Uses in... | Howmedica Osteonics Corp | MEH | ||
| Z-1051-2011 | Omnifit M/S PSL Porous Coated Acetabular Shell 50MM; Stryker Orthopaedics, Uses in... | Howmedica Osteonics Corp | MEH | ||
| Z-1050-2011 | Omnifit M/S PSL Porous Coated Acetabular Shell 48MM; Stryker Orthopaedics, Uses in... | Howmedica Osteonics Corp | MEH | ||
| Z-1049-2011 | Omnifit M/S PSL Porous Coated Acetabular Shell 46MM; Stryker Orthopaedics, Uses in... | Howmedica Osteonics Corp | MEH | ||
| Z-1048-2011 | Omnifit M/S PSL Porous Coated Acetabular Shell 44MM; Stryker Orthopaedics, Uses in... | Howmedica Osteonics Corp | MEH |