RecallRadar

FDA Device recall Z-1591-2023

Vapor-Clean, Part Number 111AU The Vapor-Clean filter is intended to be used to remove unwanted anesthetic gases from the patient breathing…

On 2023-05-24 the FDA classified a Class II recall of Vapor-Clean, Part Number 111AU The Vapor-Clean filter is intended to be used to remove unwanted anesthetic gases from the patient breathing… by Dynasthetics, citing due to a manufacturing issue that may result in filter leakage.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1591-2023
ClassificationClass II
Statusongoing
Initiated2022-05-09
Published2023-05-24
Last updated2026-09-13 11:56 UTC
CompanyDynasthetics
Distributionn/a

Product

Vapor-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.

Reason

Due to a manufacturing issue that may result in filter leakage.

Identifiers

code_infoPart Number: 111AU UDI-DI Code: 30858545007012 Lot Number: 0222P

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1591-2023%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.