RegWardenFDA facility compliance records
Recall

Class II — Vero Biotech, LLC

Recalling firmVero Biotech Inc.
Registered facilityVERO BIOTECH INC. (the firm's only registered facility)
ClassificationClass II
StatusOngoing
ReasonCassette did not meet an 1n-process flow criterion.
ProductVERO BIOTECH GENOSYL DS (Delivery System) Generation 3 Cassette, Model Number 602722-01; generates and delivers nitric oxide (NO) for inhalation at the point of use
Quantity2 cassettes
DistributionUS: AZ and FL
Initiated2023-11-17
Classified2023-12-15
Recall numberZ-0564-2024
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Vero Biotech, LLC (Z-0564-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/93475/

Not open yet

Alerts for Vero Biotech Inc.

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.