RegWardenFDA facility compliance records
Company

Vero Biotech Inc.

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

Recalls by year

FDA actions on record by year2021: 2 recalls; 2023: 1 recalls201720182019202022021202212023202420252026
  • Recalls (3)

Registered facilities (1)

Recalls & enforcement

  • Class IIOngoing2023-11-17
    Cassette did not meet an 1n-process flow criterion.
  • Class ICompleted2021-09-09
    Manufacturing defect involving reversal of the inlet and outlet gas lines, resulting in delivery of nitrogen dioxide (NO2) instead of nitric oxide (NO).
  • Class ITerminated2021-05-19
    Reports received of NO measured below desired dose during transition between primary console and backup console since Software Version 2.2.3 was uploaded to consoles in the field.

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. “Vero Biotech 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-10095885-vero-biotech-inc/

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