The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-0081-2025·Announced 2024-10-30

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.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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.
Category
Medical Device — Anesthesia Equipment
Hazard
Affected units
4,790

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 11 recalled by Datex-Ohmeda, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 11 products in this recall →

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