RegWardenFDA facility compliance records
Facility

MASTER & FRANK (CAMBODIA) CO., LTD.

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

Activity by year

FDA actions on record by year2017: 1 recalls; 2019: 1 inspections120172018120192020202120222023202420252026
  • Recalls (1)
  • Inspections (1)

Devices registered here (1)

Recalls & enforcement

  • Class IIOngoing2017-06-01
    The sleeve seam of the breathable material was found to have inconsistent sealing, which has the potential to allow fluid to flow pass through the protective seam.

FDA inspections (1)

  • VAI2019-01-31
    Voluntary 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. “MASTER & FRANK (CAMBODIA) CO., LTD. (FEI 3010014065) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3010014065-master-frank-cambodia-co-ltd/

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