Recall Z-0720-2026 ยท BSZ Gas-Machine, Anesthesia
Mindray DS USA, Inc. dba Mindray North America
Sevoflurane (SEVO) V90 Electronic Vaporizer with the A9 Anesthesia System. Labeled as the following: 1. Sev E_Vap. (Safety Filling adapter), Part Number: 115-066756-00. 2. Exchange Sev E_Vap. (Safety Filling adapter), Part Number: E115-066756-00. Product Description: The Anesthesia System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthet
| Date | Nov 26, 2025 (initiated Oct 20, 2025) |
| Status | Open, Classified |
| Reason | Potential for anesthesia leakage. |
| Root cause | Device Design |
| Action | 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 thro |
| Quantity | 148 units |
| Distribution | Worldwide - US Nationwide distribution in the states of California, Florida, Georgia, Kentucky, Maryland, Mississippi, Missouri, New Jersey, Puerto Rico, Texas, Washington, West Virginia and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K201957 | A8, A9 Anesthesia System Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Mar 26, 2021 |