Mindray DS USA, Inc. recalled 54 units of the Isoflurane V90 Electronic Vaporizer on October 20, 2025. The recall stems from a potential anesthesia leakage issue that poses serious health risks. Affected devices were distributed in the U.S. and Canada.
Potential for anesthesia leakage.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Mindray DS USA, Inc. dba Mindray North America or your healthcare provider for instructions. Notification method: Letter
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The recall affects the Isoflurane (ISO) V90 Electronic Vaporizer with the A9 Anesthesia System. The recalled models include Part Number 115-066758-00 and serial numbers ranging from AH6B44000671 to AH6B45000859. These devices were sold worldwide, including U.S. states such as California, Florida, and Texas.
The vaporizer has a potential for anesthesia leakage, which can compromise patient safety during procedures. This issue falls under Class II classification, indicating a moderate risk of adverse health consequences.
Currently, there are no reported injuries or incidents directly associated with this recall. The company has acted proactively to prevent potential risks.
Patients and healthcare providers must stop using the device immediately. Follow the recall instructions provided by the manufacturer and contact Mindray DS USA, Inc. for further guidance.
For more information, contact Mindray DS USA, Inc. at their official website or through the FDA recall notice. Additional details are available at the FDA recall page.
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