NEUROVISION MEDICAL PRODUCTS, INC.
3 recall(s) on record — most severe on record: Class II.
Activity by year
- Recalls (3)
- Inspections (2)
Devices registered here (1)
- Cystometric Gas (Carbon-Dioxide) On Hydraulic DeviceProduct code FAP (opens in a new tab) · Class II · Gastroenterology, Urology · 21 CFR 876.1620
Recalls & enforcement
- Class IIOngoing2025-05-19Product packaging contains the wrong part number and kit contents.
- Class IIOngoing2024-07-01mislabeling; EMG RLN monitoring kit labeling contains the incorrect tube size.
- Class IITerminated2020-07-21The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may soften over time so that it may be more susceptible to damage by scratching or bending, which could stop or inhibit the EMG signal transmission of the electrodes to the monitor and r…
FDA inspections (2)
- NAI2024-02-13No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
- VAI2016-09-30Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.
Related
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)
Cite this record
RegWarden. “NEUROVISION MEDICAL PRODUCTS, INC. (FEI 1930870) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1930870-neurovision-medical-products-inc/
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