RegWardenFDA facility compliance records
Company

TOMY International, Inc.

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

Recalls by year

FDA actions on record by year2022: 1 recalls20172018201920202021120222023202420252026
  • Recalls (1)

Registered facilities (1)

Recalls & enforcement

  • Class IIOngoing2022-12-02
    Affected lots of the product are being recalled due to potential microbial growth in the fluid inside the device. if a compromised product is used by a child with a weakened immune system, an infection or other illness could occur.

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. “TOMY International, Inc. — 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-9100882-tomy-international-inc/

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