Isoflurane (ISO) V90 Electronic Vaporizer with the A9 Anesthesia System. Labeled as the following: 1. Iso E_Vap. (Safety
FDA device recall Z-0721-2026 · posted 2025-11-26 · Open, Classified
Recall details
- Recalling firm
- Mindray DS USA, Inc. dba Mindray North America
- Reason for recall
- Potential for anesthesia leakage.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- BSZ
- Quantity affected
- 54 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 count
- Date initiated
- 2025-10-20
- Date posted
- 2025-11-26
- Location
- Mahwah, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| A8, A9 Anesthesia System (K201957) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2021-03-26 |