Datex-Ohmeda Auxiliary Common Gas Outlet Conversion Kits Recalled
Datex-Ohmeda is recalling 649 Auxiliary Common Gas Outlet (ACGO) conversion kits due to a potential issue if a patient breathing circuit limb is mistakenly connected to the ACGO port.
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: The agency classified this recall as Class I — 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. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port."
Plain-English summary
Datex-Ohmeda, Inc. is recalling 649 units of Auxiliary Common Gas Outlet (ACGO) conversion and installation kits. These kits are sold under the product names CONV KIT SCGO TO ACGO and ACGO ASSY FIELD INSTL. The recall includes these kits because they are purchased with or later used to convert to the ACGO system, even though the kits themselves are not specifically affected by the defect.
The recall is issued due to a potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port. The affected devices are not model or lot specific; all devices of the indicated products configured with the ACGO option are potentially affected. The spare part numbers for these kits are 1009-8249-000 and 1011-8071-000.
The products were distributed worldwide, including the United States and numerous international locations. No specific illnesses or injuries are reported in the source text. Healthcare facilities and users should verify if they possess these specific conversion kits and follow the instructions provided by Datex-Ohmeda, Inc. for the recall.
The recalled product
- Product
- Auxiliary Common Gas Outlet (ACGO) conversion/install kits sold under product names CONV KIT SCGO TO ACGO and ACGO ASSY FIELD INSTL. These kits are not affected specifically, however are included due to being purchased with or later used to convert to ACGO.
- Manufacturer
- Datex-Ohmeda, Inc.
- Affected units
- 649
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- No GTIN. Spare Part Numbers: 1009-8249-000
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 · incorrect connection
See all →- SevereDraeger Medical Recalls VentStar Basic 180 Breathing Circuits
FDA (Devices) · 2019-01-30
- SevereDraeger Medical Recalls VentStar Basic Breathing Circuits Due to Assembly Error
FDA (Devices) · 2019-01-30
- SevereDraeger Medical Recalls ID Circuit Watertrap Breathing Circuits Due to Assembly Error
FDA (Devices) · 2019-01-30
- SevereDraeger Medical Recalls ID Circuit Basic 250 Breathing Circuits
FDA (Devices) · 2019-01-30
- SevereDraeger Medical Recalls 10 VentStar Anesthesia Breathing Circuits
FDA (Devices) · 2019-01-30
Similar recalls
- HighDatex-Ohmeda Aisys CS2 Anesthesia Systems Recalled for Gas Mixer Defect
FDA (Devices) · 2026-09-23
- HighAtos Medical Recalls Provox Life Night HME Devices Due to Insertion Risk
FDA (Devices) · 2021-05-19
- HighDatex-Ohmeda Aisys Anesthesia Systems Recalled for Gas Mixer Defect
FDA (Devices) · 2026-09-23
- HighCardiac Assist Recalls 38 TandemHeart ProtekDuo Kits Due to Assembly Error
FDA (Devices) · 2020-05-20
- HighGE Healthcare Compact Airway Modules Recalled for Pump Failure Risk
FDA (Devices) · 2014-06-25
- SevereAcutus Medical AcQGuide Introducer Recalled for Foreign Material Particulates
FDA (Devices) · 2020-04-29