Reported Sep 23, 2026 · Ongoing · Updated Sep 29, 2026

Et Control, Software option for anesthesia gas machine to achieve and maintain targeted end tidal oxygen and anesthetic…

Datex-Ohmeda, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Datex-Ohmeda, Inc. · 3030 Ohmeda Dr · Madison, WI · 53718-6704

Is this the product you have?

Et Control, Software option for anesthesia gas machine to achieve and maintain targeted end tidal oxygen and anesthetic agents, Field
replaceable unit (FRU) part numbers
- 1011-8000-000-S
- 5700665

Lot codes and dates: Serial Numbers
410 of 410 codes
801042711
801031045
801031926
801045423
801011743
801090568
801128677
801011276-1
801011276-10
801011276-11
801011276-12
801011276-13
801011276-14
801011276-15
801011276-2
801011276-3
801011276-4
801011276-5
801011276-6
801011276-7
801011276-8
801011276-9
801078342-1
801078342-10
801078342-11
801078342-12
801078342-13
801078342-14
801078342-15
801078342-16
801078342-17
801078342-18
801078342-19
801078342-2
801078342-20
801078342-21
801078342-22
801078342-23
801078342-24
801078342-25
801078342-26
801078342-27
801078342-28
801078342-29
801078342-3
801078342-30
801078342-4
801078342-5
801078342-6
801078342-7
801078342-8
801078342-9
801102924
801108227
801113705
801114965
801084897
801003006
801004394
801071735
Amount recalled: 410 units

This recall covers 3 products

The agency filed one notice per product. You are reading one of them; the other 2 are below.

Where it was sold

Nationwide

Why it was recalled

Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition to Alternate O2 control. In Alternate O2 control, the system delivers 100% O2 to the breathing system enabling continued controlled or manual ventilation and initiates audible and visual alarms. When this issue occurs, anesthetic agent delivery will be interrupted and requires clinician intervention. If this is not provided, the patient may experience decreased anesthetic agent effect.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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