RegWardenFDA facility compliance records
Company

Synapse Biomedical Inc.

2 recall(s) on record — most severe on record: Class I.

Recalls by year

FDA actions on record by year2022: 2 recalls20172018201920202021220222023202420252026
  • Recalls (2)

Registered facilities (1)

Recalls & enforcement

  • Class ITerminated2022-07-11
    Due to a defect identified on the EPG controller printed circuit board assembly, device performance may degrade over time. Depending on the failure mode, potential adverse events include pain, muscle fatigue and decreased breathing effectiveness, arrhythmia or cardiac arrest, or …
  • Class IIITerminated2022-05-31
    Firm has revised labeling to consistently call out storage conditions and revised the instructions for use to clarify that the temperature range symbol is intended to indicate storage conditions (versus transport conditions or tolerance conditions for the package material).

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. “Synapse Biomedical 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-10024968-synapse-biomedical-inc/

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