The Recall Desk
SevereFDA (Devices)·Z-0082-2025·Announced 2024-10-30

Aisys CS2 Anesthesia Machine Recall: Breathing Circuit Misconnection Risk

Datex-Ohmeda is recalling approximately 15,739 Aisys CS2 anesthesia machines worldwide. A breathing circuit limb may be mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port instead of the intended connection point.

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: FDA Class I designation requires minimum severity of 4 per the hazard-assessment rubric. No illnesses or injuries have been reported. The hazard is a potential equipment misconnection in an anesthesia setting.

Plain-English summary

Datex-Ohmeda, Inc. is recalling approximately 15,739 units of the Aisys CS2 anesthesia machine. The device is intended to provide general inhalation anesthesia and ventilatory support to patients under the care of medical professionals trained in anesthesia administration. The recall is due to a potential issue that may arise if a limb of the patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port instead of the intended connection.

The affected equipment has been distributed worldwide, including throughout the United States and to over 100 countries. All devices configured with the AGCO option are subject to this recall. Healthcare providers should ensure that patient breathing circuits are connected according to the manufacturer's specifications and instructions. Facilities should contact Datex-Ohmeda or review the official FDA recall notice for further guidance.

The recalled product

Product
Aisys CS2. 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
15,739

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 →

Related recalls

Same manufacturer · Datex-Ohmeda, Inc.

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