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-2322-2019 | Class II | Kit BD Max Cdiff EU; Catalog # 442555 | Becton Dickinson & Co | N/A | |
| Z-2321-2019 | Class II | Kit BD Max Check-Points CPO IVD EU; Catalog # 278102 | Becton Dickinson & Co | N/A | |
| Z-2076-2019 | Class II | U3-3 Solar Blue, Laptop integrated power supply used with the Solar Blue Urodynamics for... | Abbott Medical | FEN | |
| Z-1845-2020 | Class II | Fukushima suction tubes; Fukushima Malleable Tapered Suction, 3 FR, 145 MM; REF: TK-1110... | Tedan Surgical Innovations, Inc. | GEA | |
| Z-2488-2019 | Class II | HeartStart MRx Monitor/Defibrillator Model # M3535A - Product Usage: The HeartStart MRx... | Philips North America LLC | MKJ | |
| Z-2205-2019 | Class II | Philips Azurion systems with software version R1.2 -Interventional Fluoroscopic X-ray... | Philips North America LLC | OWB | |
| Z-0161-2020 | Class II | xTAG Respiratory Viral Panel (RVP): Box Label: xTAG RVP (Respiratory Viral Panel)... | Luminex Molecular Diagnostics Inc | OCC | |
| Z-2362-2019 | Class II | Roche Elecsys Anti-CCP Immunoassay Catalog # 05031656160 | Roche Diagnostics GmbH | NHX | |
| Z-2361-2019 | Class II | Roche Elecsys Anti-CCP Immunoassay Catalog # 07251670190 | Roche Diagnostics GmbH | NHX | |
| Z-2281-2019 | Class II | MED-RX POLYURETHANE FEEDING TUBES: a) 5Fr X 16" (40cm), REF 54-1650R b) 6.5Fr X16"... | Canadian Hospital Specialties Ltd. | FPD | |
| Z-0256-2020 | Class II | PORT ACCESS INFUSION KIT - 1" NEEDLE Product Code: DYNDC2817 | Centurion Medical Products, LP | OXQ | |
| Z-0255-2020 | Class II | Kit, Port Access Product Code: DYNDC1582A | Centurion Medical Products, LP | LRO | |
| Z-0254-2020 | Class II | Maintenance Flush Kit/Blood Draw Product Code: DT19335 | Centurion Medical Products, LP | OIB | |
| Z-0253-2020 | Class II | Port full Access Tray Product Code: DT19330 | Centurion Medical Products, LP | LRP | |
| Z-2229-2019 | Class II | Dimension Ferritin (FERR) Flex reagent cartridge DM FERR Product Usage: The FERR Flex... | Siemens Healthcare Diagnostics Inc. | JMG | |
| Z-1835-2020 | Class II | ICU Medical Cogent Hemodynamic Monitoring System, Cogent Item Number 58400-000, UDI... | Abbott Medical | DXQ | |
| Z-0929-2020 | Class II | Dexcom Receiver, REF: MT22719, (Black, Pin, Blue), Rx Only, containing software version... | Dexcom, Inc. | MDS | |
| Z-2490-2019 | Class III | This is an in vitro diagnostic product intended for use as a calibration serum in... | Randox Laboratories, Limited | JIX | |
| Z-2087-2019 | Class II | Maximum Pelvic Trainer (MPT) | Ralston Group | HIR | |
| Z-2149-2019 | Class II | Maquet Cardiopulmonary (MCP)/Getinge HLS Set Advanced 7.0. Model Number BEQ-HLS-7050 USA... | Maquet Cardiovascular Us Sales, LLC | DTZ | |
| Z-2063-2019 | Class II | Merge OrthoPACS versions 7.3, 7.3.1, 8.0 and 8.0.1 | Merge Healthcare Incorporated | LLZ | |
| Z-2062-2019 | Class II | Merge PACS versions 7.3, 7.3.1, 8.0 and 8.0.1 | Merge Healthcare Incorporated | LLZ | |
| Z-2198-2019 | Class II | Lantis system (pre-2003), Model #5835991 - Product Usage: Lantis Treatstation is to allow... | Siemens Medical Solutions USA, Inc. | IYE | |
| Z-2474-2019 | Class II | CE18TKSTN CONT EPID W/SOFT TIP NRFIT Catalog # 339191 | B Braun Medical Inc | OFT | |
| Z-2473-2019 | Class II | CE18HKN ACCU-BLOC PERIFIX KIT NRFIT Catalog # 339189 | B Braun Medical Inc | OFT | |
| Z-2472-2019 | Class II | CE18TKN ACCU-BLOC PERIFIX KIT NRFIT Catalog # 339188 | B Braun Medical Inc | OFT | |
| Z-2471-2019 | Class II | CE17TKFCSN CON EPI TRAY W/17G TUHY NRFIT Catalog # 339187 | B Braun Medical Inc | OFT | |
| Z-2470-2019 | Class II | CE17TKFCN EPID TRAY W/ 17GA TUOHY NRFIT Catalog # 339186 | B Braun Medical Inc | OFT | |
| Z-2469-2019 | Class II | CE17TKN CONT EPIDURALTUOHY NRFIT Catalog # 339183 | B Braun Medical Inc | OFT | |
| Z-2468-2019 | Class II | FEF 100N FLAT EPIDURAL FILTER NRFIT Catalog # 339160 | B Braun Medical Inc | OFT | |
| Z-2467-2019 | Class II | ES1827KN SPINAL/EPIDURAL TRAY NRFIT Catalog # 339115 | B Braun Medical Inc | OFT | |
| Z-2466-2019 | Class II | ES1725KFXN ESPOCAN SPINAL/EPID TRY NRFIT Catalog # 339114 | B Braun Medical Inc | OFT | |
| Z-2197-2019 | Class II | Lantis Commander, Model # 4503178 - Product Usage: Lantis Treatstation is to allow the... | Siemens Medical Solutions USA, Inc. | IYE | |
| Z-2196-2019 | Class II | Lantis 8.3 Commander, Model # 8148178 - Product Usage: Lantis Treatstation is to allow... | Siemens Medical Solutions USA, Inc. | IYE | |
| Z-2195-2019 | Class II | Lantis 6.1 Commander, Model # 5493072 - Product Usage: Lantis Treatstation is to allow... | Siemens Medical Solutions USA, Inc. | IYE | |
| Z-2097-2019 | Class II | Burstberry Laser Projection Series | Gk Photonics Inc | REA | |
| Z-2096-2019 | Class II | Logolas Laser Projection Series | Gk Photonics Inc | REA | |
| Z-2095-2019 | Class II | Maxim Laser Projection Series | Gk Photonics Inc | REA | |
| Z-2094-2019 | Class II | Spectrum Laser Projection Series | Gk Photonics Inc | BRX | |
| Z-2093-2019 | Class II | Atom Laser Projection Series | Gk Photonics Inc | REA | |
| Z-2092-2019 | Class II | ClubMax Laser Projection Series | Gk Photonics Inc | REA | |
| Z-2290-2019 | Class II | IMMULITE 2000 Progesterone; Models US: L2KPW2, L2KPW6 and OUS: L2KPW2(D), L2KPW6(D); SMN... | Siemens Healthcare Diagnostics Inc. | JLS | |
| Z-2289-2019 | Class II | IMMULITE 1000 Progesterone, Model LKPW1, SMN Number 10381128 | Siemens Healthcare Diagnostics Inc. | JLS | |
| Z-2320-2019 | Class II | ABL90 FLEX Analyzer REF 393090 UDI:05700693930909 | Radiometer America, Inc | CEM | |
| Z-2345-2019 | Class II | MAGNETOM Prisma magnetic resonance diagnostic devices Model #10849582 | Siemens Medical Solutions USA, Inc. | LNH | |
| Z-2344-2019 | Class II | MAGNETOM Spectra magnetic resonance diagnostic devices Model # 10837643 | Siemens Medical Solutions USA, Inc. | LNH | |
| Z-2343-2019 | Class II | MAGNETOM Skyra magnetic resonance diagnostic devices Model # 10432915 | Siemens Medical Solutions USA, Inc. | LNH | |
| Z-2342-2019 | Class II | MAGNETOM Aera magnetic resonance diagnostic devices Model # 10432914 | Siemens Medical Solutions USA, Inc. | LNH | |
| Z-2397-2019 | Class II | Phadia" 1000 Model # 12-3800-01 Product Usage: The instrument is fully integrated and... | Phadia AB | DHB | |
| Z-0028-2020 | Class II | Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities... | Voco GmbH | EBF |