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.
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: 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.
- 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.
See all →- HighDatex-Ohmeda Aisys CS2 Anesthesia Systems Recalled for Gas Mixer Defect
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Aisys Anesthesia Systems Recalled for Gas Mixer Defect
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Aisys CS2 Anesthesia Systems Recalled for Gas Mixer Defect
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Et Control Software Recalled for Anesthetic Delivery Interruption
FDA (Devices) · 2026-09-23
- SevereGiraffe and Panda warmer blender knobs may deliver wrong oxygen concentration
FDA (Devices) · 2026-06-24
Similar recalls
- HighDatex-Ohmeda Aisys CS2 Anesthesia Systems Recalled for Gas Mixer Defect
FDA (Devices) · 2026-09-23
- HighGE Datex-Ohmeda Aisys CS2 Anesthesia System Recalled for Damaged Flow Sensors
FDA (Devices) · 2020-11-11
- HighDatex-Ohmeda Aisys Anesthesia Systems Recalled for Gas Mixer Defect
FDA (Devices) · 2026-09-23
- SevereGE Aisys Anesthesia System Recalled for Potential Barotrauma Risk
FDA (Devices) · 2016-01-27
- SevereGE Healthcare Anesthesia Systems Recalled for Potential Transducer Connection Reversal
FDA (Devices) · 2022-07-27
- HighGE Healthcare Anesthesia Systems Recalled for Potential Barotrauma Risk
FDA (Devices) · 2016-01-27