HIGH

Mindray Sevoflurane V90 Vaporizer Recalled for Leakage Risk in A9 System (148 Units)

Mindray DS USA recalled 148 Sevoflurane V90 electronic vaporizers used with the A9 Anesthesia System. The devices have a potential for anesthesia leakage. Healthcare facilities should stop using the device immediately and follow manufacturer instructions.

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

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

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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

  1. Review the recall notice for Part Numbers 115-066756-00 and E115-066756-00
  2. Check device labels for the two Part Numbers and verify serial numbers listed
  3. Confirm if your facility has the A9 Anesthesia System with V90 vaporizers
  4. 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

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

  • 148 units recalled
  • Worldwide distribution; US states listed: CA, FL, GA, KY, MD, MS, MO, NJ, PR, TX, WA, WV; Canada
  • Part Numbers 115-066756-00 and E115-066756-00
  • Serial numbers AH6A45000871, AH6A45000880, AH6A45000881, AH6A46000929, AH6A46000931, AH6A46000944,AH
  • DI: 06936415975777
  • Hazard: anesthesia leakage with potential exposure to anesthetic gas

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
5/ 10
Affected Groups
GENERALPREGNANTELDERLYCHILDRENINFANTSPETS
Injury Types
OTHER

Product Details

Brand
Model Numbers
115-066756-00
E115-066756-00
AH6A45000871
AH6A45000880
AH6A45000881
+15 more
Affected States
ALL
Report Date
December 3, 2025
Recall Status
ACTIVE

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