Facility

Tianjin Puli Ark Medical Technology Co., Ltd

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)	3025749544
Establishment type	Manufacture Medical Device for Another Party (Contract Manufacturer)
Location	1F and 4F, Building 6, Block B, No. 6 Huafeng Rd. Dongli District Tianjin, CN 30030
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. “Tianjin Puli Ark Medical Technology Co., Ltd (FEI 3025749544) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3025749544-tianjin-puli-ark-medical-technology-co-l/

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