Recall Z-0720-2026— Mindray DS USA, Inc. dba Mindray North America
Class II · Ongoing
Class II FDA medical device recall by Mindray DS USA, Inc. dba Mindray North America, initiated 2025-10-20. It names one FDA 510(k) clearance: K201957. 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: Potential for anesthesia leakage..
- Recalling firm
- Mindray DS USA, Inc. dba Mindray North America
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-10-20
- Firm location
- Mahwah, NJ, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.