Isoflurane (ISO) V90 Electronic Vaporizer with the A9 Anesthesia System. Labeled as the following...
FDA Device Recall #Z-0721-2026 — Class II — October 20, 2025
Recall Summary
| Recall Number | Z-0721-2026 |
| Classification | Class II — Moderate risk |
| Date Initiated | October 20, 2025 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Mindray DS USA, Inc. dba Mindray North America |
| Location | Mahwah, NJ |
| Product Type | Devices |
| Quantity | 54 units |
Product Description
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.
Distribution Pattern
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.
Lot / Code Information
1. Part Number 115-066758-00; DI 06936415975753; Serial Numbers: AH6B44000714, AH6B44000719, AH6B44000722, AH6B44000724, AH6B44000733, AH6B44000734, AH6B44000782, AH6B45000836, AH6B45000837, AH6B45000840, AH6B45000844, AH6B45000858, AH6B44000717, AH6B44000786, AH6B44000785, AH6B44000788, AH6B45000859, AH6B44000671, AH6B44000673, AH6B44000705, AH6B44000706, AH6B44000707, AH6B44000708, AH6B44000709, AH6B44000710, AH6B44000711, AH6B44000712, AH6B44000713, AH6B44000715, AH6B44000716, AH6B44000718, AH6B44000723, AH6B44000725, AH6B44000726, AH6B44000727, AH6B44000728, AH6B44000729, AH6B44000730, AH6B44000731, AH6B44000783, AH6B44000787, AH6B44000790, AH6B45000839, AH6B45000854, AH6B44000732, AH6B45000856, AH6B44000789, AH6B45000842, AH6B45000841, AH6B45000845, AH6B45000850, AH6B45000852, AH6B45000853. 2. Part Number E115-066758-00; 06936415975753; Serial Number: AH6B44000672.
Other Recalls from Mindray DS USA, Inc. dba Mindray Nort...
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0920-2026 | Class II | Hardware configuration of the BeneVision Centra... | Nov 18, 2025 |
| Z-0720-2026 | Class II | Sevoflurane (SEVO) V90 Electronic Vaporizer wit... | Oct 20, 2025 |
| Z-2622-2025 | Class II | BeneVision N1 Patient Monitor (N1). Part Number... | Aug 15, 2025 |
| Z-2950-2024 | Class II | Sevoflurane E_Vap.(Safety Filling adapter) used... | Jul 22, 2024 |
| Z-2951-2024 | Class II | Isoflurane E_Vap.(Safety Filling adapter): used... | Jul 22, 2024 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.