Facility

NOAH MEDICAL Corp.

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

Key facts

5recalls · worst Class II

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3033628477
Establishment type	Develop Specifications But Do Not Manufacture At This Facility
Location	975 Industrial Rd San Carlos, CA, US 94070
Registration status	Active · expires 2026
Parent company	Noah Medical (owner-operator 10087546)
Brand names	Galaxy System; Galaxy system bronchoscope and accessory kit

Activity by year

Recalls (5)

Devices registered here (1)

Bronchoscope (Flexible Or Rigid)
Product code EOQ (opens in a new tab) · Class II · Ear, Nose, Throat · 21 CFR 874.4680

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. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “NOAH MEDICAL Corp. (FEI 3033628477) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3033628477-noah-medical-corp/

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