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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Mindray A9 Anesthesia System Vaporizers Recalled for Anesthesia Leakage

Agency Publication Date: November 26, 2025
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Summary

Mindray DS USA, Inc. (dba Mindray North America) is recalling 202 units of Sevoflurane (SEVO) and Isoflurane (ISO) V90 Electronic Vaporizers used with the A9 Anesthesia System. The recall is due to the potential for anesthesia leakage from the vaporizers or their safety filling adapters. These devices are used to provide inhalation anesthetic and maintain a patient's breathing during surgical procedures. If a leak occurs, it could lead to the patient receiving an incorrect dose of anesthesia or expose healthcare staff to hazardous gases.

Risk

Anesthesia leakage can cause a patient to wake up during surgery or lead to accidental exposure of medical personnel to anesthetic vapors, which poses a health risk to both patients and staff.

What You Should Do

  1. This recall affects Sevoflurane and Isoflurane V90 Electronic Vaporizers used with the A9 Anesthesia System, including safety filling adapter models with part numbers 115-066756-00, E115-066756-00, 115-066758-00, and E115-066758-00.
  2. Identify if your device is affected by checking the part number and serial number on the device label. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled device immediately.
  4. Contact Mindray DS USA, Inc. or your authorized distributor to arrange for a return, replacement, or correction of the anesthesia vaporizer.
  5. For additional questions or to report issues, call the FDA Consumer Complaint hotline at 1-888-463-6332.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Sevoflurane (SEVO) V90 Electronic Vaporizer (A9 Anesthesia System)
Variants: Sev E_Vap. (Safety Filling adapter), Exchange Sev E_Vap. (Safety Filling adapter)
Model / REF:
115-066756-00
E115-066756-00
Serial Numbers (148):
AH6A45000871
AH6A45000880
AH6A45000881
AH6A46000929
AH6A46000931
AH6A46000944
AH6A47001200
AH6A44000657
AH6A44000658
AH6A44000661
AH6A44000664
AH6A44000677
AH6A44000678
AH6A44000680
AH6A44000768
AH6A44000778
AH6A46000925
AH6A46000927
AH6A46000928
AH6A46000935
AH6A46000937
AH6A46001114
AH6A47001159
AH6A47001164
AH6A47001174
AH6A47001201
AH6A45000872
AH6A46000932
AH6A46000939
AH6A46000940
AH6A47001196
AH6A47001202
AH6A47001207
AH6A47001215
AH6A46001102
AH6A46001111
AH6A46001116
AH6A47001160
AH6A47001161
AH6A47001163
AH6A47001165
AH6A47001166
AH6A47001167
AH6A47001178
AH6A46001097
AH6A46001117
AH6A44000645
AH6A44000647
AH6A44000648
AH6A44000651
UDI:
06936415975777

Quantity: 148 units

Product: Isoflurane (ISO) V90 Electronic Vaporizer (A9 Anesthesia System)
Variants: Iso E_Vap. (Safety Filling adapter), Exchange Iso E_Vap. (Safety Filling adapter)
Model / REF:
115-066758-00
E115-066758-00
Serial Numbers (54):
AH6B44000714
AH6B44000719
AH6B44000722
AH6B44000724
AH6B44000733
AH6B44000734
AH6B44000782
AH6B45000836
AH6B45000837
AH6B45000840
AH6B45000844
AH6B45000858
AH6B44000717
AH6B44000786
AH6B44000785
AH6B44000788
AH6B45000859
AH6B44000671
AH6B44000673
AH6B44000705
AH6B44000706
AH6B44000707
AH6B44000708
AH6B44000709
AH6B44000710
AH6B44000711
AH6B44000712
AH6B44000713
AH6B44000715
AH6B44000716
AH6B44000718
AH6B44000723
AH6B44000725
AH6B44000726
AH6B44000727
AH6B44000728
AH6B44000729
AH6B44000730
AH6B44000731
AH6B44000783
AH6B44000787
AH6B44000790
AH6B45000839
AH6B45000854
AH6B44000732
AH6B45000856
AH6B44000789
AH6B45000842
AH6B45000841
AH6B45000845
UDI:
06936415975753

Quantity: 54 units

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97810
Status: Active
Manufacturer: Mindray DS USA, Inc. dba Mindray North America
Sold By: Authorized distributors; Direct medical sales
Manufactured In: United States
Units Affected: 2 products (148 units; 54 units)
Distributed To: California, Florida, Georgia, Kentucky, Maryland, Mississippi, Missouri, New Jersey, Puerto Rico, Texas, Washington, West Virginia

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.