RegWardenFDA facility compliance records
Company

Intrinsic Therapeutics Inc.

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

Recalls by year

FDA actions on record by year2020: 1 recalls; 2024: 1 recalls201720182019120202021202220231202420252026
  • Recalls (2)

Registered facilities (1)

Recalls & enforcement

  • Class IIOngoing2024-07-25
    At least two units have been found to be missing a weld.
  • Class IITerminated2020-07-24
    The catalog ( REF ) number on the peelable inner labels (patient sticker) that is on the inner container (box) is incorrect. It states BAR-A8-10MM instead of BAR-A8-8MM.

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. “Intrinsic Therapeutics 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-10023198-intrinsic-therapeutics-inc/

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