Isoflurane — Class II medical device recall Z-0721-2026
Ongoing recall by Mindray DS USA, Inc. dba Mindray North America, reported 2025-12-03, distributed nationwide. Potential for anesthesia leakage.
| Recall number | Z-0721-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mindray DS USA, Inc. dba Mindray North America, Mahwah, NJ, United States |
| Recall initiated | 2025-10-20 |
| Classified | 2025-11-26 |
| Reported by FDA | 2025-12-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 54 units |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 06936415975753 |
| Serial numbers | AH6B44000671, AH6B44000672, AH6B44000673, AH6B44000705, AH6B44000706, AH6B44000707, AH6B44000708, AH6B44000709, AH6B44000710, AH6B44000711, AH6B44000712, AH6B44000713, AH6B44000714, AH6B44000715, AH6B44000716, AH6B44000717, AH6B44000718, AH6B44000719, AH6B44000722, AH6B44000723, AH6B44000724, AH6B44000725, AH6B44000726, AH6B44000727, AH6B44000728 and 29 more |
| Model numbers | 115-066758-00, E115-066758-00 |
Product
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.
Reason for recall
Potential for anesthesia leakage.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0721-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.