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-1639-2011 | HSV-1 IgG ELISA kit ; HSV-1 IgM ELISA kit; BioCheck, Foster City, CA 9440. Quantitative... | BioCheck Inc | LGC | ||
| Z-1638-2011 | CVM IgG ELISA kit ; CVM IgM ELISA kit BioCheck, Foster City, CA 9440. Quantitative... | BioCheck Inc | OMI | ||
| Z-1637-2011 | Toxoplasma IgG ELISA kit ; Toxoplasma IgM ELISA kit BioCheck, Foster City, CA... | BioCheck Inc | LGD | ||
| Z-1636-2011 | Rubella IgG ELISA kit ; Rubella IgM ELISA kit BioCheck, Foster City, CA... | BioCheck Inc | LFX | ||
| Z-1635-2011 | H pylori IgG ELISA kit (Qualitative) H pylori IgG ELISA kit (Quantitive) H pylori IgG... | BioCheck Inc | LYR | ||
| Z-1634-2011 | Visual hCG ELISA kit BioCheck, Foster City, CA 9440. Quantitative determination of AFP... | BioCheck Inc | DHA | ||
| Z-1633-2011 | Free beta-hCG ELISA kit BioCheck, Foster City, CA 9440. Quantitative determination of... | BioCheck Inc | DHA | ||
| Z-1632-2011 | Free PSA ELISA Kit. BioCheck, Foster City, CA 9440. Quantitative determination of AFP... | BioCheck Inc | LTJ | ||
| Z-1631-2011 | PSA ELISA Kit. BioCheck, Foster City, CA 9440. Quantitative determination of AFP... | BioCheck Inc | LTJ | ||
| Z-1630-2011 | CA19-9 ELISA Kit. BioCheck, Foster City, CA 9440. Quantitative determination of AFP... | BioCheck Inc | NIG | ||
| Z-1629-2011 | CA15-3 ELISA Kit. BioCheck, Foster City, CA 9440. Quantitative determination of AFP... | BioCheck Inc | LTK | ||
| Z-1628-2011 | CA125 ELISA Kit. BioCheck, Foster City, CA 9440. Quantitative determination of AFP... | BioCheck Inc | LTK | ||
| Z-1627-2011 | CEA ELISA Kit. BioCheck, Foster City, CA 9440. Quantitative determination of AFP... | BioCheck Inc | DHX | ||
| Z-1626-2011 | AFP ELISA Kit; AFP ELISA kit (Extended range); BioCheck, Foster City, CA... | BioCheck Inc | LOJ | ||
| Z-1874-2011 | Toshiba Infinix-i, DFP-8000D The expected usage of these devices is for fluoroscopy... | Canon Medical Systems USA, Inc. | JAA | ||
| Z-1873-2011 | Toshiba Infinix-i, INFX-8000V The expected usage of these devices is for fluoroscopy... | Canon Medical Systems USA, Inc. | JAA | ||
| Z-1872-2011 | Toshiba Infinix-i, INFX-8000F The expected usage of these devices is for fluoroscopy... | Canon Medical Systems USA, Inc. | JAA | ||
| Z-1871-2011 | Toshiba Infinix-i, INFX-8000C The expected usage of these devices is for fluoroscopy... | Canon Medical Systems USA, Inc. | JAA | ||
| Z-1926-2011 | Inhibin A ELISA kit, Part Number: DSL-10-28100T-4 The Inhibin A ELISA kit is intended for... | Siemens Healthcare Diagnostics Inc. | NDR | ||
| Z-1925-2011 | Inhibin A ELISA kit, Part Number: DSL-10-28100-4 The Inhibin A ELISA kit is intended for... | Siemens Healthcare Diagnostics Inc. | NDR | ||
| Z-0939-2011 | Linemaster Wireless Footswitch, VASER System, REF Vaser 2.0, Sound Surgical Technologies... | Solta Medical, Inc. | GEI | ||
| Z-1028-2011 | ThermiSense model 5700-A5 The ThermiSense Model 5700-A5 is a nasal cannula that detects... | Salter Labs | BZQ | ||
| Z-1373-2011 | Orthoralix 8500 DDE Panoramic Dental X-Ray System; Extraoral x-ray unit with timer... | Gendex Corp. | EHD | ||
| Z-0936-2011 | Super Arrow-Flex(R) PSI Set Intended for use in the hospital catheterization laboratory... | Arrow International LLC (subsidiary of Teleflex Incorporated) | DYB | ||
| Z-1032-2011 | SeedNet MRI Cryosurgical System, model FPRCH2035, and the following system is not... | Galil Medical Ltd. | GEH | ||
| Z-1031-2011 | Presice Cryosurgical System, model FPRCH2047, and the following system is not approved in... | Galil Medical Ltd. | GEH | ||
| Z-1820-2011 | Brilliance 64 S/N 9089, 9551, 9548. The Brilliance 64 is a Computed Tomography X-Ray... | Philips North America LLC | JAK | ||
| Z-1063-2011 | Inrad sample master aspiration biopsy needle with hiliter sharp bevel needle, 22 ga x 2... | RLS Interventional Inc. dba Inrad | GAA | ||
| Z-1559-2011 | Wall Mounting Plate, an accessory to the Gendex eXpert DC (REF 110-0205G1) and 765DC (REF... | Gendex Corp. | EHD | ||
| Z-1024-2011 | Laryngoscope Handle, Reusable, Rx, Product Code 4558GSP or 4559LED, Vital Signs Colorado... | Vital Signs Colorado, Inc. | CCW | ||
| Z-1399-2011 | Abbott RealTime HBV Assay, List 2N40, in vitro diagnostic; Abbott Molecular Inc., Des... | Abbott Molecular, Inc. | MKT | ||
| Z-1398-2011 | Abbott RealTime HIV-1 Assay, List 6L18, in vitro diagnostic; Abbott Molecular Inc., Des... | Abbott Molecular, Inc. | MTL | ||
| Z-1397-2011 | Abbott RealTime CT/NG Assay, List 8L07, in vitro diagnostic; Abbott Molecular Inc., Des... | Abbott Molecular, Inc. | LSK | ||
| Z-1595-2011 | AMPLATZER Sizing Balloon II, REF 9-SB-034, Sterile EO, AGA Medical Corporation, 5050... | Abbott Medical | MJN | ||
| Z-1372-2011 | Medstorm Adult Radiolucent Zoll Medical (Part # 16381, HeartSync, Ann Arbor, MI. The... | Graphic Controls Acquisition Corp.dba Nissha Medical Technologies | MLN | ||
| Z-1371-2011 | Medstorm Adult Radiolucent Electrode Philips Medical , Part #16250, HeartSync Ann... | Graphic Controls Acquisition Corp.dba Nissha Medical Technologies | MLN | ||
| Z-1864-2011 | Cardiac Marker Control Calibration Verification Set, List number 136604/06F15-02. Used... | Abbott Medical | JJX | ||
| Z-1863-2011 | Cardiac Marker Control Level 1, List Number 136601-06F12-02; Cardiac Marker Control Level... | Abbott Medical | JJX | ||
| Z-1518-2011 | LICOX CMP Tissue Oxygen Monitor; Catalog numbers REF AC31. Manufacturer GMS Gesellschaft... | Integra LifeSciences Corporation | GWM | ||
| Z-0941-2011 | Prelude Short Sheath Introducer, 7F-SMT, 4 cm, REF No: PSS-7F-4-038MT, Sterile EO, Merit... | Merit Medical Systems, Inc. | DYB | ||
| Z-0987-2011 | Physiological Monitoring, Patient Monitor M31250 Information Center Local... | Philips North America LLC | MHX | ||
| Z-1248-2011 | Gendex Dental Systems, Gendex eXpert DC Intraoral X-Ray System; a dental x-ray system... | Gendex Corp. | EHD | ||
| Z-2164-2011 | S5-7606 Silicone Oil injection Cannula 6mm Long - 20G REF 585247 High Viscosity... | Becton Dickinson & Co | HMX | ||
| Z-2163-2011 | S5-7604 Silicone Oil Injection Cannula 4mm Long - 20G REF 585246 High Viscosity... | Becton Dickinson & Co | HMX | ||
| Z-2162-2011 | BD Visitec High Viscosity Injector 6mm .90mm (20G) [Hammer] Catalog Number: 585228 High... | Becton Dickinson & Co | HMX | ||
| Z-2161-2011 | BD Visitec High Viscosity Injector 4mm [Hammer] .90 (20G) Catalog Number: 585208 High... | Becton Dickinson & Co | HMX | ||
| Z-2160-2011 | BD Visitec High Viscosity Injector 6mm [Hammer] .90mm (20G) Catalog Number: 585184 High... | Becton Dickinson & Co | HMX | ||
| Z-2159-2011 | BD Visitec High Viscosity Injector 4mm .90 (20G) [Hammer] REF 585173 High Viscosity... | Becton Dickinson & Co | HMX | ||
| Z-2528-2017 | Class II | M3150 Information Center Local Database; Models: 862249, 865001, 865003, 865004, 865007... | Philips North America LLC | MHX | |
| Z-1228-2011 | Thomas Medical Products, Acuity Bleed back Control Valve, Acuity Rotating Hemostasis... | Merit Medical Systems, Inc. | DQY |