RegWardenFDA facility compliance records
Company

BC Group International, Inc.

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

Recalls by year

FDA actions on record by year2015: 1 recalls1201520162017201820192020202120222023202420252026
  • Recalls (1)

Registered facilities (1)

Recalls & enforcement

  • Class IIITerminated2015-10-28
    Device is not functioning as intended: Two wires running to the ECG distribution circuit board are reversed resulting in inverted waveforms.

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. “BC Group 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-10037117-bc-group-international-inc/

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