Recall archive / FDA device enforcement
Vapor-Clean, Part Number 111AU The Vapor-Clean filter is intended to be used to remove unwanted anesthetic gases from... — FDA record Z-1591-2023
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date May 9, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Classification
- Class II
- Recalling firm
- Dynasthetics LLC
- Quantity
- 28 filters
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1591-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Part Number: 111AU UDI-DI Code: 30858545007012 Lot Number: 0222P |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
U.S.: N/A O.U.S.: Australia
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- May 24, 2023
- Recall initiation date
- May 9, 2022
- Center classification date
- May 16, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.