RegWardenFDA facility compliance records
Facility

KUNG SHIN PLASTICS CO., LTD.

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

Activity by year

FDA actions on record by year2025: 1 recalls20172018201920202021202220232024120252026
  • Recalls (1)

Devices registered here (1)

  • Filter, Bacterial, Breathing-Circuit
    Product code CAH (opens in a new tab) · Class II · Anesthesiology · 21 CFR 868.5260

Recalls & enforcement

  • Class IIOngoing2025-01-09
    The machine side connector of the filter HME may be occluded by plastic which prevents proper airflow. The issue may lead to ventilation bag malfunction in which the user is unable to inflate/deflate properly during manual ventilation. Potential risks to health include oxygen dep…

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. “KUNG SHIN PLASTICS CO., LTD. (FEI 3004116032) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3004116032-kung-shin-plastics-co-ltd/

Not open yet

Alerts for KUNG SHIN PLASTICS CO., LTD.

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.