Anesthesia System Vaporizer Adapter Recalled for Potential Anesthetic Overdose
Mindray's Isoflurane E_Vap adapter for the A9 Anesthesia System is recalled due to a seal defect that may cause higher-than-intended anesthetic concentration delivery. Twenty-four units were distributed to eight U.S. states and Canada.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall with no reported injuries, illnesses, or hospitalizations in the source document. The hazard involves potential anesthetic overdose if the seal defect occurs; the A9 system includes alarms to warn clinicians. Per the severity rubric, risk-of-harm medical devices where injury has not been reported receive a High score.
Plain-English summary
The FDA has issued a Class II recall of Mindray's Isoflurane E_Vap Safety Filling adapter (Part Number 115-066758-00), used with the A9 Anesthesia System. The adapter is designed to deliver controlled vapor concentrations of isoflurane anesthetic to patients during anesthesia.
The recalled adapter contains a component with a defect that can cause an incomplete seal, resulting in anesthetic agent output exceeding the set concentration in some cases. The A9 Anesthesia System includes built-in alarms to alert clinicians to abnormal vaporizer output. However, if anesthetic concentrations are too high, patients may inhale excessive amounts of the anesthetic agent.
Excessive anesthetic exposure can cause post-operative symptoms including vertigo and drowsiness. In severe cases, patients may experience neurological effects such as memory loss and attention difficulties. Twenty-four units of the affected adapter have been distributed to healthcare facilities in California, Georgia, Kentucky, Mississippi, New Jersey, Puerto Rico, Texas, and West Virginia, as well as to Canada.
Affected healthcare facilities should verify their equipment against the serial numbers listed in the recall notice and contact Mindray for replacement or remediation instructions.
The recalled product
- Product
- Isoflurane E_Vap.(Safety Filling adapter): used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with controllable concentration to an A9 anesthesia system. Part Number: Part Number 115-066758-00
- Manufacturer
- Mindray DS USA, Inc. dba Mindray North America
- Hazard
- anesthetic-overdose
- equipment-malfunction
Distribution
Distribution scope not specified by the agency.
Related recalls
Same category
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03
- SevereAbiomed Automated Impella Controller recalled for motor control and pump failure risks
FDA (Devices) · 2026-06-03
- HighGE APEXPRO and CARESCAPE Telemetry Systems Risk Loss of Patient Monitoring
FDA (Devices) · 2026-06-03
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03