Reported Sep 23, 2026 · Ongoing · Updated Oct 7, 2026
Aisys, Datex-Ohmeda anesthesia system, Part Number 1011-9050-000
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?
- Aisys, Datex-Ohmeda anesthesia system, Part Number 1011-9050-000
- Lot codes and dates
- UDI-DI00840682102292
- Serial Numbers
475 of 475 codes
APWC01722APWF00169APWF00170APWF00173APWF00174APWF00111APWF00368APWF00402APWF00465APWF00467APWF00468APWF00469APWF00470APWF00471APWF00472APWF00473APWF00474APWF00475APWF00476APWF00477APWT00394APWC01107APWF00436APWE01910APWE01911APWV00635APWW01464APWW01625APWF00380APWF00381APWF00382APWY00358APWF00359APWF00313APWE01925APWV02342APWE01915APWF00458APWF00433APWD02646APWC01330APWC01339APWC01340APWF00279APWF00280APWF00281APWF00282APWF00283APWF00284APWF00285APWF00286APWF00287APWF00288APWF00289APWF00290APWF00262APWF00312APWX00800APWX00804APWF00138
- Amount recalled
- 475 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.
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