Anesthesia Gas Machine Recall: Breathing Circuit Misconnection Risk
Datex-Ohmeda is recalling Avance anesthesia gas machines worldwide due to a potential hazard if a patient's breathing circuit is incorrectly connected to the Auxiliary Common Gas Outlet port during setup.
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 recalls carry a minimum severity rating of 4 per established rules. No deaths or serious injuries are reported in the source text. This classification is Severe.
Plain-English summary
Datex-Ohmeda, Inc. is recalling the Avance anesthesia gas machine due to a potential hazard related to equipment connections. A patient's breathing circuit limb could be incorrectly connected to the Auxiliary Common Gas Outlet (ACGO) port during setup, creating a potential safety issue.
This recall affects 9,349 units of the Avance anesthesia gas machine, which have been distributed worldwide, including throughout the United States.
Medical personnel should verify that breathing circuit limbs are connected only to the appropriate connection points and not to the Auxiliary Common Gas Outlet. Facilities should review their setup procedures and contact Datex-Ohmeda for guidance on inspection and any recommended corrective actions.
The recalled product
- Product
- Avance. 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.
- Affected units
- 9,349
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
Same hazard · breathing circuit misconnection
See all →- SevereAmingo Anesthesia System: Risk of Breathing Circuit Misconnection to Auxiliary Outlet
FDA (Devices) · 2024-10-30
- SevereAespire 7900 Anesthesia Gas Machine Recalled Over Breathing Circuit Misconnection Risk
FDA (Devices) · 2024-10-30
- SevereAespire 7100 Anesthesia Machines Recalled for Breathing Circuit Misconnection
FDA (Devices) · 2024-10-30
- SevereAisys CS2 Anesthesia Machine Breathing Circuit Misconnection Hazard
FDA (Devices) · 2024-10-30
Similar recalls
- HighGE Datex-Ohmeda Avance 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
- HighDatex-Ohmeda Aisys CS2 Anesthesia Systems Recalled for Gas Mixer Defect
FDA (Devices) · 2026-09-23
- HighGE Healthcare Anesthesia Systems Recalled for Potential Barotrauma Risk
FDA (Devices) · 2016-01-27
- SevereGE Aisys Anesthesia System Recalled for Potential Barotrauma Risk
FDA (Devices) · 2016-01-27
- SevereDraeger Medical Recalls 10 VentStar Anesthesia Breathing Circuits
FDA (Devices) · 2019-01-30