RegWardenFDA facility compliance records
Company

Omnia SRL

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

Recalls by year

FDA actions on record by year2021: 1 recalls20172018201920201202120222023202420252026
  • Recalls (1)

Registered facilities (2)

Recalls & enforcement

  • Class IITerminated2021-03-30
    Omnia SRL received a notification from the contract manufacturer informing them of inadequate sterilization processes which have been taking place at their contracted sterilizing facility since 2016.

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. “Omnia SRL — 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-9059817-omnia-srl/

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