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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Mindray DS USA, Inc. dba Mindray North America
- Reason for Recall:
- Potential for anesthesia leakage.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full 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.
Product Codes/Lot Numbers:
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.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0721-2026
Related Recalls
Potential for anesthesia leakage.
Potential for activation of an abnormal alarm pause.
V90 electronic vaporizer anesthetic agent output may be higher than the set amount due to a component within the vaporizer causing an incomplete seal in some cases. Should this issue occur, the A9 Anesthesia System will generate alarms associated with abnormal vaporizer output. If the anesthetic concentration is too high, the patient can inhale too much anesthetic agent; the patient may suffer from symptoms such as vertigo and drowsiness after the operation. In severe cases, the patient may suffer from neurological sequelae such as hypomnesia and inattention