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-0906-2007 | c.cam Gamma Camera, Model 9VIR1200; Siemens Medical Solutions USA, Inc., Molecular... | Siemens Medical Solutions USA, Inc. | KPS | ||
| Z-0793-2007 | CIBASoft Visitint Soft Contact Lenses, SKU #749591001385, Power -6.50, Diameter 13.8... | Alcon Laboratories | LPL | ||
| Z-0920-2007 | Roche VALP2, Online TDM Valproic acid , for use with the Roche/Hitachi Cobas c 501... | Roche Diagnostics GmbH | LEG | ||
| Z-0919-2007 | Roche VANC2, Online TDM Vancomycin, for use with the Roche/Hitachi Cobas c 501analyzer... | Roche Diagnostics GmbH | LEH | ||
| Z-0459-2009 | Sun Med GreenLine/D Laryngoscope Blades Compatible with Fiber Optic Green System Handles... | Salter Labs | CCW | ||
| Z-1234-2007 | The product is an isolation transformer, an accessory to Computed Tomography Scanner. It... | Philips North America LLC | JAK | ||
| Z-1007-2007 | Medtronic MiniMed Paradigm Insulin Infusion Pumps for the following Paradigm models... | Medtronic, Inc. | LZG | ||
| Z-0820-2007 | VITROS Immunodiagnostic Products Troponin I Reagent Pack, REF/Catalog No. 194 9882. A... | Ortho-Clinical Diagnostics, Inc. | MMI | ||
| Z-0936-2007 | Electrode Belt, component of the LifeVest Wearable Defibrillator, Product number... | ZOLL Manufacturing Corporation | MVK | ||
| Z-0925-2007 | LIFEPAK 20 defibrillator/monitor. The device is an AC powered defibrillator device with... | Physio Control, Inc. | MJK | ||
| Z-1821-2008 | Psi Bands acupressure/acustimulation wrist bands in the following colors: Racer Black... | Psi Health Solutions, Inc. | MVV | ||
| Z-0484-2008 | SERFAS Energy Suction Probe, Model 279-351-100, 3.5mm 90-S, Manufactured by Stryker... | Stryker Corp. | GEI | ||
| Z-0935-2007 | HUMIDIFLOW Respiratory Gas Humidifier; Manufactured by: Porous Media Corporation 1350... | Pentair Filtration Solutions | BTT | ||
| Z-0987-2007 | HD11XE Diagnostic Ultrasound System | Philips North America LLC | IYN | ||
| Z-0811-2007 | Certain MicroMiniplant Straight Healing Abutment. Dental implant. Model numbers: ISMHA32... | ZimVie US Corp LLC | DZE | ||
| Z-0014-2008 | Brain Heart Infusion Agar labeled BHIA + Vancomycin 6 MCG/ML For Screening for... | PML, Inc. dba Pml Microbiologicals Inc. | JSO | ||
| Z-1163-2007 | Sunrise Medical Quickie Power Wheelchairs: Three models -Rhythm, Groove, and Zippy Z-Bop... | Sunrise Medical, Inc. | ITI | ||
| Z-0838-2007 | BD AutoShield Pen Needle (Re order Number : 329300) | Becton Dickinson & Co | FMI | ||
| Z-1040-2007 | AxSYM HBsAg Reagent Pack; list 09B01; 100 test pack; in-vitro diagnostic; Abbott... | Abbott Medical | LOM | ||
| Z-1039-2007 | AxSYM HAVAB 2.0 Reagent Pack; list 08D21; 100 test pack; in-vitro diagnostic; Abbott... | Abbott Medical | LOL | ||
| Z-1038-2007 | AxSYM CORE-M 2.0 Reagent Pack; list 08B89; 100 test pack; in-vitro diagnostic; Abbott... | Abbott Medical | LOM | ||
| Z-1037-2007 | AxSYM CORE 2.0 Reagent Pack; list 08B88; 100 test pack; in-vitro diagnostic; Abbott... | Abbott Medical | LOM | ||
| Z-1036-2007 | AxSYM HAVAB-M 2.0 Reagent Pack; list 05E20; 100 test pack; in-vitro diagnostic; Abbott... | Abbott Medical | LOL | ||
| Z-1035-2007 | AxSYM CMV IgM Reagent Pack; list 05C78; 100 test pack; in-vitro diagnostic; Abbott... | Abbott Medical | LKQ | ||
| Z-1034-2007 | AxSYM Anti-HCV Reagent Pack; list 05C36; 100 test pack; in-vitro diagnostic; Abbott... | Abbott Medical | MZO | ||
| Z-1033-200 | AxSYM CMV IgG Reagent Pack; list 04B47; 100 test pack; in-vitro diagnostic; Abbott... | Abbott Medical | LFZ | ||
| Z-1032-2007 | AxSYM Rubella IgM Reagent Pack; list 04B46; 100 test pack; in-vitro diagnostic; Abbott... | Abbott Medical | LFX | ||
| Z-1031-2007 | AxSYM Toxo IgM Reagent Pack; list 04B25; 100 test pack; in-vitro diagnostic; Abbott... | Abbott Medical | LGD | ||
| Z-1030-2007 | AxSYM Myoglobin Reagent Pack; list 03E43; 100 test pack; in-vitro diagnostic; Abbott... | Abbott Medical | DDR | ||
| Z-1029-2007 | AxSYM Folate Reagent Pack; list 03C81 ; 100 test pack; in-vitro diagnostic; Abbott... | Abbott Medical | CGN | ||
| Z-1028-2007 | AxSYM AUSAB Reagent Pack; list 03C74; 100 test pack; in-vitro diagnostic; Abbott... | Abbott Medical | LOM | ||
| Z-1027-2007 | AxSYM CA 15-3 Reagent Pack; list 03B42; 100 test pack; an in vitro diagnostic; Abbott... | Abbott Medical | MOI | ||
| Z-1026-2007 | AxSYM CA 125 Reagent Pack; list 03B41; 100 test pack; an in vitro diagnostic; Abbott... | Abbott Medical | LTK | ||
| Z-1025-2007 | AxSYM Rubella IgG Reagent Pack; list 03B23; 100 test pack; an in vitro diagnostic; Abbott... | Abbott Medical | LFX | ||
| Z-1024-2007 | AxSYM Toxo IgG Reagent Pack; list 03B22; 100 test pack; an in vitro diagnostic; Abbott... | Abbott Medical | LGD | ||
| Z-1023-2007 | AxSYM Troponin-I ADV Reagent Pack; list 02J44; 100 test pack; in-vitro diagnostic... | Abbott Medical | MMI | ||
| Z-1006-2007 | ResMed S8 Continuous Positive Airway Pressure (CPAP) Flow generator with the following... | ResMed Corp | BZD | ||
| Z-0795-2007 | Gynecare PROLIFT Total Pelvic Repair System PFRT01 Ethicon Deutschland | Ethicon, Inc | FTM | ||
| Z-1086-2007 | SPI EASY Abutment. Endosseous dental implant abutment. | Thommen Medical AG | DZE | ||
| Z-0810-2007 | Roche PTH (parathyroid hormone test system) for use in conjunction with Roche cobas e... | Roche Diagnostics GmbH | CEW | ||
| Z-0315-2008 | COULTER GEN*S System, Part Number: 6605381, Beckman Coulter, Brea, CA. (Hematology... | Siemens Healthcare Diagnostics Inc. | GKL | ||
| Z-0314-2008 | COULTER LH 500 Series System, Part Number: 178833, Beckman Coulter, Brea, CA... | Siemens Healthcare Diagnostics Inc. | GKZ | ||
| Z-0313-2008 | COULTER LH780 Analyzer , Part Number: 723585, Beckman Coulter, Brea, CA. (Hematology... | Siemens Healthcare Diagnostics Inc. | GKZ | ||
| Z-0312-2008 | COULTER LH750 Analyzer, Part Number 6605632, Beckman Coulter, Brea, CA. (Beckman Coulter... | Siemens Healthcare Diagnostics Inc. | GKZ | ||
| Z-1195-2007 | Varian On-Board Imager Device versions 1.2 and 1.3, when used with Cone Beam Computed... | Varian Medical Systems, Inc. | IYE | ||
| Z-0801-2007 | Biohorizons 3.0mm Overdenture Implant System, REF 30120S2, (3 mm x12 mm-2mm collar)... | BioHorizons Implant Systems Inc | DZE | ||
| Z-0819-2007 | Horizon Pump Metriset Burette Set. The product is shipped in cases containing 20 sets. | B Braun Medical Inc | FPA | ||
| Z-0818-2007 | Ultrasite Horizon Pump IV Set. The product is shipped in cases containing 24 sets. | B Braun Medical Inc | FPA | ||
| Z-1110-2007 | Medtronic Intersept Filtered Cardiotomy Reservoir, Model 1351, Non-pyrogenic, Sterile... | Medtronic Perfusion Systems | DTZ | ||
| Z-0130-2008 | GreenLight HPS System, Surgical Laser System and Accessories. Part Numbers 0010-0070 and... | American Medical Systems Innovation Center - Silicon Valley | GEX |