RegWardenFDA facility compliance records
Company

TRINITY STERILE, INC.

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

Recalls by year

FDA actions on record by year2021: 1 recalls; 2022: 1 recalls; 2024: 1 recalls2017201820192020120211202220231202420252026
  • Recalls (3)

Registered facilities (1)

Recalls & enforcement

  • Class IIOngoing2024-12-13
    Potential for hole in package compromising sterility of the medical kit.
  • Class IITerminated2022-06-29
    Kits mislabeled as latex-free, the packaging for component 94-7002 Non-Adherent Dressing contains natural rubber latex. Potential risk to to those with latex allergy
  • Class IITerminated2021-02-23
    Evidence of face masks or other material in the seal in several kits, causing improper seals and compromised sterility

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. “TRINITY STERILE, 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-9003800-trinity-sterile-inc/

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