The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-0080-2025·Announced 2024-10-30

Anesthesia gas machines pose risk of breathing circuit misconnection

Avance CS2 and Avance CS2 Pro anesthesia machines may permit breathing circuit misconnection to the wrong gas outlet. Affected devices have the AGCO option and are distributed worldwide.

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 classification mandates a minimum severity score of 4 per the rubric. While no illnesses or injuries are reported, the Class I designation reflects the FDA's determination that this hazard poses a serious risk to patient safety.

Plain-English summary

Datex-Ohmeda, Inc. is recalling Avance CS2 and Avance CS2 Pro anesthesia machines with the AGCO option. These devices provide general inhalation anesthesia and ventilatory support and are used only by medical professionals trained in anesthesia administration. The recall affects 12,559 units distributed worldwide, including throughout the United States.

A potential safety issue may occur if a patient's breathing circuit limb is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port. This misconnection poses a potential hazard during anesthesia administration.

All units of the recalled models with the AGCO option are affected, regardless of serial number. Medical facilities using these anesthesia machines should contact Datex-Ohmeda, Inc. for remediation guidance.

The recalled product

Product
Avance CS2 and Avance CS2 Pro. These anesthesia gas machines are 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
12,559

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 (3)

  • GTIN: 00840682102322. Model Numbers: 1009-9050-000
  • 1011-9050-000
  • 1009-9002-000

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 →

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