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-0727-2017 | Class II | AMD-Ritmed Transparent Dressing - Window with label, 4 " x 4 3/4" (10 cm x 12 cm)... | Amd-Ritmed, Inc. | NAC | |
| Z-0005-2017 | Class I | HeartWare Ventricular Assist System Controller Product Usage: For use as a... | HeartWare, Inc. | DSQ | |
| Z-2282-2016 | Class III | Instructions for Use (IFU) for Progesterone 3 Calibrator Set, repackaged as one... | Tosoh Bioscience Inc | JIT | |
| Z-2214-2016 | Class II | Depuy Synthes Trauma- Trochanteric Fixation Nail Advanced (TFNA) Blade/Screw Guide... | Synthes (USA) Products LLC | FZX | |
| Z-2124-2016 | Class II | Magnetic Resonance System G-scan Brio (Part Number /Model No.101002000) | Esaote S.p.A. | LNH | |
| Z-2187-2016 | Class II | Target Detachable Coils: TARGET HELICAL NANO 3MM X 8CM MODEL... | Stryker Corp. | HCG | |
| Z-2186-2016 | Class II | Target Detachable Coils: TARGET HELICAL NANO 3MM X 6CM MODEL... | Stryker Corp. | HCG | |
| Z-2185-2016 | Class II | Target Detachable Coils: TARGET HELICAL NANO 3MM X 4CM MODEL... | Stryker Corp. | HCG | |
| Z-2184-2016 | Class II | Target Detachable Coils: TARGET HELICAL NANO 3MM X 4CM MODEL... | Stryker Corp. | HCG | |
| Z-2183-2016 | Class II | Target Detachable Coils: TARGET HELICAL NANO 2.5MM X 4CM MODEL... | Stryker Corp. | HCG | |
| Z-2182-2016 | Class II | Target Detachable Coils: TARGET HELICAL NANO 2.5MM X 3CM MODEL... | Stryker Corp. | HCG | |
| Z-2181-2016 | Class II | Target Detachable Coils: TARGET HELICAL NANO 2MM X 6CM MODEL... | Stryker Corp. | HCG | |
| Z-2180-2016 | Class II | Target Detachable Coils: TARGET HELICAL NANO 2MM X 4CM MODEL... | Stryker Corp. | HCG | |
| Z-2179-2016 | Class II | Target Detachable Coils: TARGET HELICAL NANO 2MM X 3CM MODEL... | Stryker Corp. | HCG | |
| Z-2178-2016 | Class II | Target Detachable Coils: TARGET HELICAL NANO 2MM X 2CM MODEL... | Stryker Corp. | HCG | |
| Z-2177-2016 | Class II | Target Detachable Coils: TARGET 360 NANO 3.5 MM X 6CM MODEL... | Stryker Corp. | HCG | |
| Z-2176-2016 | Class II | Target Detachable Coils: TARGET 360 NANO 3MM X 6CM MODEL Number:M0035443060 Neurology... | Stryker Corp. | HCG | |
| Z-2175-2016 | Class II | Target Detachable Coils: TARGET 360 NANO 3MM X 4CM MODEL Number:M0035443040 Neurology... | Stryker Corp. | HCG | |
| Z-2174-2016 | Class II | Target Detachable Coils: TARGET 360 NANO 2.5 MM X 4CM MODEL... | Stryker Corp. | HCG | |
| Z-2173-2016 | Class II | Target Detachable Coils: TARGET 360 NANO 2MM X 4CM MODEL Number:M0035442040 Neurology... | Stryker Corp. | HCG | |
| Z-2172-2016 | Class II | Target Detachable Coils: TARGET 360 NANO 2MM X 3CM MODEL Number:M0035442030 Neurology... | Stryker Corp. | HCG | |
| Z-2171-2016 | Class II | Target Detachable Coils: TARGET HELICAL NANO 1.5 MM X 4 CM MODEL... | Stryker Corp. | HCG | |
| Z-2170-2016 | Class II | Target Detachable Coils: TARGET HELICAL NANO 1.5 MM X 3 CM MODEL... | Stryker Corp. | HCG | |
| Z-2169-2016 | Class II | Target Detachable Coils: TARGET HELICAL NANO 1.5 MM X 2 CM MODEL... | Stryker Corp. | HCG | |
| Z-2168-2016 | Class II | Target Detachable Coils: TARGET HELICAL NANO 1.5 MM X 1 CM MODEL... | Stryker Corp. | HCG | |
| Z-2167-2016 | Class II | Target Detachable Coils: TARGET HELICAL NANO 1 MM X 3 CM MODEL... | Stryker Corp. | HCG | |
| Z-2166-2016 | Class II | Target Detachable Coils: TARGET HELICAL NANO 1 MM X 2 CM MODEL... | Stryker Corp. | HCG | |
| Z-2165-2016 | Class II | Target Detachable Coils: TARGET HELICAL NANO 1 MM X 1 CM MODEL... | Stryker Corp. | HCG | |
| Z-2164-2016 | Class II | Target Detachable Coils: TARGET 360 NANO 1.5 MM X 4 CM MODEL... | Stryker Corp. | HCG | |
| Z-2163-2016 | Class II | Target Detachable Coils: TARGET 360 NANO 1.5 MM X 3 CM MODEL Number... | Stryker Corp. | HCG | |
| Z-2162-2016 | Class II | Target Detachable Coils: TARGET 360 NANO 1.5 MM X 2 CM MODEL Number... | Stryker Corp. | HCG | |
| Z-2161-2016 | Class II | Target Detachable Coils: TARGET 360 NANO 1 MM X 3 CM MODEL Number... | Stryker Corp. | HCG | |
| Z-2160-2016 | Class II | Target Detachable Coils: TARGET 360 NANO 1 MM X 2 CM MODEL Number... | Stryker Corp. | HCG | |
| Z-2107-2016 | Class II | SYNGO Breast Care, visualization and image enhancement tools to aid radiologist in the... | Siemens Medical Solutions USA, Inc. | LLZ | |
| Z-2123-2016 | Class II | Covidien Cytosponge Cell Collection Device. Item code CYTO-101-01. Gastroenterology... | Medtronic, Inc. | EOX | |
| Z-2122-2016 | Class II | Covidien Cytosponge Cell Collection Kit. Contains Cytosponge Cell Collection Device... | Medtronic, Inc. | EOX | |
| Z-2281-2016 | Class II | Stryker Orthopaedics Trident Constrained Liner Inserter/Impactor Tip, 22 mm, 28 mm, and... | Howmedica Osteonics Corp | LPH | |
| Z-2243-2016 | Class II | Parker Trach-Vac Endotracheal Tubes. Tyvek pouches, 10 per box. Product Usage: The... | Parker Medical | BTR | |
| Z-2202-2016 | Class II | Femoral Arterial Line Catheterization Kit with Sharps Safety Features 510K 810675... | Arrow International LLC (subsidiary of Teleflex Incorporated) | DQX | |
| Z-2201-2016 | Class II | Femoral Arterial Line Catheterization Kit with Sharps Safety Features 510K 810675... | Arrow International LLC (subsidiary of Teleflex Incorporated) | DQX | |
| Z-2302-2016 | Class II | VITROS Immunodiagnostic Products Total T4 Reagent Pack, REF/Product Code 874 4468... | Ortho-Clinical Diagnostics, Inc. | KLI | |
| Z-2136-2016 | Class II | ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | |
| Z-0312-2017 | Class III | PhoenixSpec AP Calibrator is used to calibrate the PhoenixSpec & Phoenix AP Instruments... | Becton Dickinson & Co | LON | |
| Z-0311-2017 | Class III | PhoenixSpec Calibrator & Kit is used to calibrate the PhoenixSpec & Phoenix AP... | Becton Dickinson & Co | LON | |
| Z-0314-2017 | Class II | SimpliRED D-Dimer, Product Code DSRK4 The SimpliRED D-dimer assay is a rapid, qualitative... | Bbi Solutions OEM Limited | GHH | |
| Z-2096-2016 | Class I | AngioDynamics Soft Vu Omni Flush Angiographic Catheter Model Number: 10732203 | Stryker Sustainability Solutions | DQO | |
| Z-0757-2017 | Class II | Ultrasound Video Bronchoscope The EB-1970UK, Ultrasound Video Bronchoscope, is intended... | PENTAX of America, Inc. | EOQ | |
| Z-2875-2016 | Class II | Pentax Video Bronchoscope Designed to be used with a Pentax Video Processor (including... | PENTAX of America, Inc. | EOQ | |
| Z-2215-2016 | Class I | Oxylog 3000, Disposable Pediatric Patient Circuit, Catalog Number: 5704964 The VentStar... | Draeger, Inc. | CBK | |
| Z-2138-2016 | Class II | Synthes Ti Button Plate 7 Holes, Fastener, Fixation, nondegradable, Soft Tissue | Synthes (USA) Products LLC | MBI |