CLASS II ONGOING Device recall · Reported 3 Dec 2025 · FDA Enforcement Report
The Anesthesia System is a device used to administer recalled
Mindray DS USA is recalling The Anesthesia System is a device used to administer to a patient, continuously or, distributed nationwide in the US. The recall was initiated on 20 Oct 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0721-2026
- FDA event ID
- 97810
- Recalling firm
- Mindray DS USA, Mahwah, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 20 Oct 2025
- FDA classified
- 26 Nov 2025
- Reported
- 3 Dec 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 20 Oct 2025 | Recall initiated by company | |
| 26 Nov 2025 | Classified by FDA | +37 days |
| 3 Dec 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential for anesthesia leakage.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Isoflurane (ISO) V90 Electronic Vaporizer with the A9 Anesthesia System. Labeled as the following: 1. Iso E_Vap. (Safety Filling adapter), Part Number 115-066758-00. 2. Exchange Iso E_Vap. (Safety Filling adapter), Part Number E115-066758-00. Product Description: The Anesthesia System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The A9 Anesthesia System utilizes V90 electronic vaporizers for anesthetic agent delivery.
Where it was distributed
Worldwide - US Nationwide distribution in the states of California, Florida, Georgia, Kentucky, Maryland, Mississippi, Missouri, New Jersey, Puerto Rico, Texas, Washington, West Virginia and the country of Canada.
Nationwide CaliforniaFloridaGeorgiaKentuckyMarylandMissouriMississippiNew JerseyPuerto RicoTexasWashingtonWest Virginia
Questions about this recall
Why was it recalled?
Potential for anesthesia leakage.
Which lots are affected?
1. 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, 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, AH6B45000850, AH6B45000852, AH6B45000853. 2. Part Number E115-066758-00; 06936415975753; Serial Number: AH6B44000672.
Where was it sold?
Worldwide - US Nationwide distribution in the states of California, Florida, Georgia, Kentucky, Maryland, Mississippi, Missouri, New Jersey, Puerto Rico, Texas, Washington, West Virginia and the country of Canada.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 97810This product is part of a recall event; the main page for the event is The Anesthesia System is a device used to administer recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | The Anesthesia System is a device used to administer recalled | Mindray DS USA | Packaging Defects | Nationwide |
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