Quality & complianceOfficial

Health Canada lists Class II recall of Datex-Ohmeda Carestation 850 anaesthesia systems over reduced agent delivery

🇨🇦 Health Canada · Tue 10 Nov 2026

Carestation 850 and 850c systems can deliver a lower concentration of anaesthetic agent than intended, according to a Health Canada recall notice for Datex-Ohmeda, Inc.

Health Canada has published a health product recall for the Carestation 850 anaesthesia system, made by Datex-Ohmeda, Inc. The notice, last updated on 10 November 2026, states that Carestation 850 and 850c Anesthesia Systems can deliver a reduced concentration of anaesthetic agent.

The recall is classed as Type II and carries identification number RA-82934. The manufacturer's recall date is given as 28 October 2026, and Health Canada's original publication date is 10 November 2026. The notice is categorised under medical devices in anaesthesiology, with the issue described as a performance problem. Healthcare professionals are the stated audience.

The affected product is listed as Carestation 850 under catalogue or model number 1012-9850-000. The notice says more than 10 lot or serial numbers are involved and does not list them, directing readers to the manufacturer for the full set. Datex-Ohmeda is based at 3030 Ohmeda Drive, Madison, Wisconsin.

The only action given is for readers to contact the manufacturer if they need further information. The notice does not describe the cause of the fault, any reported incidents or injuries, or any corrective action such as a repair or software update. For context, Health Canada uses Type II for recalls where use of a product may cause temporary or medically reversible adverse effects, or where the likelihood of serious harm is remote.

What it means for your team

  • Quality and device-vigilance teams at hospitals and distributors in Canada should check whether any Carestation 850 or 850c units fall within the affected serial numbers, which are available only from the manufacturer.
  • Regulatory affairs teams tracking Datex-Ohmeda may want to watch for equivalent notices from other authorities, as the Health Canada entry does not mention other markets.
  • The notice gives no root cause or corrective action, so detail on remediation will need to come from the manufacturer.

Official source: Health Canada ↗

Article written by VigiEye from the official source (Health Canada). AI-assisted; check the source before acting.

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