RegWardenFDA facility compliance records
Recall

Class II — Dynasthetics LLC

Recalling firmDynasthetics
Registered facilityDynasthetics (the firm's only registered facility)
ClassificationClass II
StatusOngoing
ReasonDue to a manufacturing issue that may result in filter leakage.
ProductVapor-Clean, Part Number 111AU The Vapor-Clean filter is intended to be used to remove unwanted anesthetic gases from the patient breathing circuit. The device uses two anesthetic vapor adsorbent canisters connected to an anesthesia delivery system to prevent unwanted anesthetic vapors emanating from within an anesthesia gas machine from reaching a patient.
Quantity28 filters
DistributionU.S.: N/A O.U.S.: Australia
Initiated2022-05-09
Classified2023-05-16
Recall numberZ-1591-2023
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 — Dynasthetics LLC (Z-1591-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/92026/

Not open yet

Alerts for Dynasthetics

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.