RegWardenFDA facility compliance records
Company

GUANGZHOU WONDFO BIOTECH CO., LTD.

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

Recalls by year

FDA actions on record by year2018: 1 recalls20171201820192020202120222023202420252026
  • Recalls (1)

Registered facilities (2)

Recalls & enforcement

  • Class IIOngoing2018-05-18
    GUANGZHOU WONDFO BIOTECH discovered on the TCube One Step Multi-Drug Oral Fluid Test Cube the potential for failure of the saliva collection device. The use of the saliva collection device could cause the foam tip to become dislodged in the user's mouth creating a choking hazar…

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “GUANGZHOU WONDFO BIOTECH CO., LTD. — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-9064561-guangzhou-wondfo-biotech-co-ltd/

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