RegWardenFDA facility compliance records
Facility

BESMED HEALTH BUSINESS CORP.-Chiayi

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

Activity by year

FDA actions on record by year2018: 1 recalls; 2026: 1 inspections201712018201920202021202220232024202512026
  • Recalls (1)
  • Inspections (1)

Devices registered here (1)

  • Catheter, Continuous Irrigation
    Product code GBQ (opens in a new tab) · Class I · General, Plastic Surgery · 21 CFR 878.4200

Recalls & enforcement

  • Class IITerminated2018-08-09
    Ambu Aura40 Standard, Reusable Laryngeal Mask packaged in a pouch marked AuraStraight Silicone, Single Use Laryngeal Mask Sterile

FDA inspections (1)

  • NAI2026-08-20
    No Action Indicated · Compliance: Devices

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. “BESMED HEALTH BUSINESS CORP.-Chiayi (FEI 3021284283) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3021284283-besmed-health-business-corp-chiayi/

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