RegWardenFDA facility compliance records
Company

Noah Medical

5 recall(s) on record — most severe on record: Class II.

Recalls by year

FDA actions on record by year2024: 4 recalls; 2025: 1 recalls201720182019202020212022202342024120252026
  • Recalls (5)

Registered facilities (4)

Recalls & enforcement

  • Class IIOngoing2025-09-12
    Due to Users not having access to the Instructions for Use/User Manual due to it being password protected.
  • Class IIOngoing2024-10-28
    Bronchoscopic visualization system power supplies have defective semiconductor components that may fail unexpectedly, which could result in an aborted procedure since it is a non recoverable failure. Manual removal of the bronchoscope when the system is not functioning can increa…
  • Class IIOngoing2024-10-25
    Bronchoscopic system uninterruptable power may have defective component, may cause power supply short circuit/trip protective circuit breakers causing sudden, unrecoverable power loss, which could occur while system is on mains or internal battery power; if during procedure, coul…
  • Class IIOngoing2024-10-25
    Not all biopsy tools meant to fit bronchoscope channel (2.1mm inner diameter/length greater or equal to 1100mm) will pass through if scope channel positioned in sharp bend (approx. greater than 100-deg.), excessive force may result in tissue injury/pneumothorax; instruments with …
  • Class IIOngoing2024-03-09
    Due to a misaligned calibration of the wired controller that may result in unintended motion of the scope.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “Noah Medical — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-10087546-noah-medical/

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