Sevoflurane Vaporizer for A9 Anesthesia System Recalled for Output Malfunction
Mindray recalled 2 Sevoflurane E_Vap vaporizers used in A9 Anesthesia Systems due to a component defect causing excessive anesthetic output. The defect risks patient anesthetic overdose with potential neurological effects including post-operative vertigo and drowsiness.
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: FDA Class II medical device with potential for serious neurological consequences but no reported injuries or hospitalizations documented in the source. Classified as high-risk product where injury has not yet been reported, per rubric criteria.
Plain-English summary
The recalled product is the Sevoflurane E_Vap vaporizer (Quik-Fil model, Part Number 115-066755-00), designed to work with the A9 Anesthesia System to deliver controlled concentrations of sevoflurane anesthetic. Two units—serial numbers AH6D28000517 and AH6D28000518—manufactured by Mindray DS USA, Inc., have been recalled.
A component within the vaporizer may fail to seal completely, causing the device to deliver anesthetic vapor at a concentration higher than the clinician sets. The A9 system generates alarms when it detects abnormal vaporizer output. If a patient inhales excess anesthetic during the procedure, they may experience post-operative symptoms such as vertigo and drowsiness. In severe cases, neurological sequelae may occur, including hypomnesia (impaired memory) and inattention.
The affected units were distributed in the United States to California, Georgia, Kentucky, Mississippi, New Jersey, Puerto Rico, Texas, and West Virginia, and internationally to Canada.
The recalled product
- Product
- Sevoflurane E_Vap.(Quik-Fil):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 115-066755-00
- Manufacturer
- Mindray DS USA, Inc. dba Mindray North America
- Hazard
- anesthetic-overdose
- neurological-sequelae
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI-DI: 06936415975784 Serial Number: AH6D28000517
- AH6D28000518
Distribution
Distribution scope not specified by the agency.
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