Anesthesia Machine Recall Due to Patient Breathing Circuit Misconnection Risk
Datex-Ohmeda Aisys anesthesia machines may allow patient breathing circuits to be incorrectly connected to the Auxiliary Common Gas Outlet, potentially affecting ventilation during anesthesia. Approximately 4,790 units worldwide are affected.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I medical device recall, which establishes a minimum severity rating of 4. The hazard involves potential misconnection of patient breathing circuits in anesthesia equipment. While no illnesses or injuries have been reported, the potential for improper ventilation during anesthesia in critical surgical care warrants a Severe rating.
Plain-English summary
Datex-Ohmeda, Inc. is recalling Aisys anesthesia gas machines (model 1011-9000-000) configured with the Auxiliary Common Gas Outlet option. These machines deliver inhalation anesthesia and ventilatory support during surgical procedures and are used only by trained medical professionals.
A potential safety issue exists where the breathing circuit connected to a patient could be mistakenly attached to the Auxiliary Common Gas Outlet port instead of the intended outlet. This misconnection could result in improper gas delivery or inadequate patient ventilation during anesthesia.
Approximately 4,790 units have been distributed worldwide, including throughout the United States. The recall affects all serial numbers of the affected model with the AGCO option. Healthcare facilities and anesthesia personnel responsible for equipment setup should be aware of this connection risk.
Facilities using Aisys anesthesia machines should implement additional verification steps to ensure breathing circuits are properly connected only to the intended outlets. Contact Datex-Ohmeda or the FDA for specific guidance on device inspection and proper connection procedures.
The recalled product
- Product
- Aisys. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.
- Manufacturer
- Datex-Ohmeda, Inc.
- Hazard
- circuit-misconnection
- inadequate-ventilation
Distribution
Distributed nationwide across the United States.
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