Mindray DS USA, Inc. Dba Mindray North America recalls Isoflurane (ISO) V90 Electronic Vaporizer with the A9 Anesthesia System. Labeled as the…

Potential for anesthesia leakage.

Isoflurane (ISO) V90 Electronic Vaporizer with the A9 Anesthesia System. Labeled as the following: 1. Iso E_Vap. (Safety Filling adapter), Part Number 115-066758-00. 2. Exchange Iso E_Vap. (Safety Filling adapter), Part Number E115-066758-00. Product Description: The Anesthesia System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The A9 Anesthesia System utilizes V90 electronic vaporizers for anesthetic agent delivery.

Mindray notified consignees on about 10/20/2025 via letter. Consignees were informed that they could continue using the units as normal, but if an anesthetic odor or leak is detected, contact Mindray Technical Support. Interventions may include switching to another V90 vaporizer or using intravenous anesthesia as clinically appropriate. For vaporizer replacement procedures, refer to A9 Operator s Manual (Part No. H-046-017199-00, Section 3.4 Vaporizer ), available on the Mindray website. Mindray s Technical Support team can assist and may be reached at (877) 913-9663 (Option 2) Monday through Friday, 8:30 a.m. 5:30 p.m. ET. Consignees were instructed to complete and return the Acknowledgement and Receipt form provided, ensure that all applicable clinical staff are aware of the issue and maintain a copy of the recall notification with affected units or IFUs. Additionally, they were instructed to notify any organization to which the affected V90 electronic vaporizers identified have been distributed. The Mindray Care Team will contact consignees to arrange the replacement of all affected SEVO and ISO V90 electronic vaporizers located at their facility. The V90 electronic vaporizers will be shipped directly to each facility, and a Mindray Care Team representative will schedule the installation and collect the affected V90 electronic vaporizers.

• FDA enforcement recordOfficial FDA database entry for Z-0721-2026
• FDA 510(k) clearance · K201957The device's official FDA premarket clearance record
• FDA device classification · BSZOfficial FDA classification for this device type
• CFR regulation · 21 CFR 868.5160The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Mindray DS USA, Inc. dba Mindray North AmericaSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.