FDA recall Z-0720-2026

Mindray DS USA, Inc. dba Mindray North America · Class II · device

Product

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 anesthetic and to maintain a patient's ventilation. The A9 Anesthesia System utilizes V90 electronic vaporizers for anesthetic agent delivery.

Reason for recall

Potential for anesthesia leakage.

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.

Key facts

Status
Ongoing
Initiation date
2025-10-20
Report date
2025-12-03
Voluntary/Mandated
Voluntary: Firm initiated
Location
Mahwah, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0720-2026