Quick Facts at a Glance
- Recall Date
- October 20, 2025
- Hazard Level
- HIGH
- Brand
- Mindray DS USA
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
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 DS USA
- Product type
- Electronic Vaporizer for Anesthesia System
- Model numbers
- Part Number 115-066758-00, DI 06936415975753, AH6B44000714, AH6B44000719, AH6B44000722, AH6B44000724, AH6B44000733, AH6B44000734 +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 Isoflurane V90 Electronic Vaporizer is part of the A9 Anesthesia System used to deliver inhaled anesthetic agents during patient care. The system relies on vaporizers to regulate anesthetic delivery.
Why This Is Dangerous
A potential leakage of anesthesia agent from the vaporizer could expose patients and healthcare personnel to the chemical.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall affects 54 units distributed globally to healthcare facilities. Immediate cessation of use is advised to minimize exposure risk and guide facilities through recall procedures.
Practical Guidance
How to identify if yours is affected
- Check Part Number on the Iso E_Vap adapter: 115-066758-00
- Check if the device is an Exchange Iso E_Vap with Part Number E115-066758-00
Where to find product info
Identifiers are located on the Iso E_Vap adapter and related A9 System labeling. The recall notice lists exact serial numbers and part numbers.
What timeline to expect
Timeline for refunds or replacements not specified in the recall notice.
If the manufacturer is unresponsive
- escalate with facility risk management
- document all communications with Mindray DS USA
- consult hospital compliance for escalation
How to prevent similar issues
- Verify vaporizer compatibility before use
- Regularly review FDA recall databases and manufacturer notices
- Maintain an up-to-date inventory of anesthesia delivery components
- Ensure recall communications reach clinical engineering and procurement teams
Documentation advice
Keep a copy of the recall notice, record device Part Number 115-066758-00 and serial numbers, document communications with Mindray and healthcare providers, and maintain replacement records.
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Product Details
- Part Number 115-066758-00 - DI 06936415975753 - Serial Numbers: AH6B44000714, AH6B44000719, AH6B44000722, AH6B44000724, AH6B44000733, AH6B44000734, AH6B44000782, AH6B45000836, AH6B45000837, AH6B45000840, AH6B45000844, AH6B45000858, AH6B44000717, AH6B44000786, AH6B44000785, AH6B44000788, AH6B45000859, AH6B44000671 - 54 units - Distribution: Worldwide; US states listed include California, Florida, Georgia, Kentucky, Maryland, Mississippi, Missouri, New Jersey, Puerto Rico, Texas, Washington, West Virginia and Canada.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Exchange Iso E_Vap. Part Number E115-066758-00
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