Quick Facts at a Glance
- Recall Date
- October 20, 2025
- Hazard Level
- HIGH
- Brand
- Mindray
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT, ELDERLY
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Mindray
- Product type
- Electronic Vaporizer for Anesthesia System
- Model numbers
- 115-066756-00, E115-066756-00, AH6A45000871, AH6A45000880, AH6A45000881, AH6A46000929, AH6A46000931, AH6A46000944 +12 more
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
October 20, 2025
Reported by FDA DEVICE
December 3, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Potential for anesthesia leakage.
What You Should Do
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
About This Product
The Sevoflurane V90 electronic vaporizer delivers sevoflurane as part of the anesthesia delivery system. It is used in operating rooms and other clinical settings. The A9 Anesthesia System relies on V90 vaporizers for anesthetic agent delivery.
Why This Is Dangerous
A design or manufacturing issue could allow leakage of anesthesia gas from the vaporizer, potentially exposing patients and healthcare workers to anesthetic agents.
Industry Context
This recall is not described as part of a broader industry recall pattern.
Real-World Impact
Hospitals and clinics using the affected Mindray A9 system should review their inventory and stop use of the recalled vaporizers until replaced or repaired. The impact could affect patient safety and operational workflow.
Practical Guidance
How to identify if yours is affected
- Review the recall notice for Part Numbers 115-066756-00 and E115-066756-00
- Check device labels for the two Part Numbers and verify serial numbers listed
- Confirm if your facility has the A9 Anesthesia System with V90 vaporizers
- Cross-check with Mindray support for instructions
Where to find product info
Recall notification, Mindray website, FDA recall page: Z-0720-2026
What timeline to expect
Replacement or refund process through Mindray may take weeks; follow manufacturer guidance
If the manufacturer is unresponsive
- Escalate to hospital risk management
- File a report with the FDA if advised by Mindray
- Seek alternative medical device suppliers with documented recall handling
How to prevent similar issues
- Verify device recalls during procurement
- Maintain an updated inventory of anesthesia vaporizers and serial numbers
- Regularly follow Mindray communications and FDA recall notices
- Ensure staff training on recall response and device quarantine policies
Documentation advice
Keep the recall notice, device serial numbers, photos of labels, and all communications with Mindray for records
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Product Details
Part Number 115-066756-00: Sev E_Vap. (Safety Filling adapter) Part Number E115-066756-00: Exchange Sev E_Vap. (Safety Filling adapter) DI: 06936415975777 Serial Numbers: AH6A45000871, AH6A45000880, AH6A45000881, AH6A46000929, AH6A46000931, AH6A46000944, AH6A47001200, AH6A44000657, AH6A44000658, AH6A44000661, AH6A44000664, AH6A44000677, AH6A44000678, AH6A44000680, AH6A44000768, AH6A44000778, AH6A46000925, AH6A46000927 Distribution: Worldwide; US nationwide in CA, FL, GA, KY, MD, MS, MO, NJ, PR, TX, WA, WV; Canada Quantity: 148 units
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Worldwide distribution; US states listed: CA, FL, GA, KY, MD, MS, MO, NJ, PR, TX, WA, WV; Canada
- Hazard: anesthesia leakage with potential exposure to anesthetic gas
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