OVERLOOKED

Recalls › Medicines & devices

Class IIOngoing

Datex-Ohmeda, Inc. recalls 4 products

Recall date · record updated Sep 23, 2026 · Source: U.S. Food and Drug Administration (openFDA device enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
Datex-Ohmeda, Inc.
Reason
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.
Hazard
FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).
Who’s affected
Worldwide - US Nationwide distribution.
Where
Nationwide
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99649…

Products (4)

  1. Aisys, Datex-Ohmeda anesthesia system, Part Number 1011-9050-000

    Codes/lots: UDI-DI: 00840682102292; Serial Numbers: APWC01722 APWF00169 APWF00170 APWF00173 APWF00174 APWF00111 APWF00368 APWF00402 APWF00465 APWF00467 APWF00468 APWF00469 APWF00470 APWF00471 APWF00472 APWF00473 APWF00474 APWF00475 APWF00476 APWF00477 APWT00394 APWC01107 APWF00436 APWE01910 APWE01911 APWV00635 APWW01464 APWW01625 APWF00380 APWF00381 APWF00382 APWY00358 APWF00359 APWF00313 APWE01925 APWV02342 APWE01915 APWF00458 APWF00433 APWD02646 APWC01330 APWC01339 APWC01340 APWF00279 APWF00280 APWF00281 APWF00282 APWF00283 APWF00284 APWF00285 APWF00286 APWF00287 APWF00288 APWF00289 APWF00290 APWF00262 Quantity: 475 unitsRecall no. Z-3189-2026Class II

  2. Aisys CS2, Datex-Ohmeda anesthesia system, Part Number 1011-9055-000

    Codes/lots: UDI-DI: 00195278588128; Serial Numbers: AQDF40422 AQDE40769 AQDE40771 AQDF40287 AQDF40288 AQDF40290 AQDF40291 AQDF40293 AQDF40294 AQDF40295 AQDF40311 AQDF40313 AQDF40314 AQDE40754 AQDE40755 AQDE40756 AQDE40757 AQDE40759 AQDE40762 AQDE40763 AQDF40296 AQDF40300 AQDF40301 AQDF40302 AQDF40303 AQDD40441 AQDF40399 AQDF40400 AQDF40401 AQDF40423 AQDF40424 AQDF40425 AQDE40743 AQDE40744 AQDE40748 AQDE40749 AQDC40064 AQDE40427 AQDC40059 AQDE40736 AQDF40353 AQDF40354 AQDF40355 AQDF40356 AQDF40357 AQDF40358 AQDF40359 AQDF40360 AQDF40361 AQDF40362 AQDF40363 AQDF40364 AQDF40365 AQDF40366 AQDF40367 AQDF40368 Quantity: 140 unitsRecall no. Z-3190-2026Class II

  3. Aisys CS2 with Et Control, Datex-Ohmeda anesthesia system, Part Number 1011-9000-000

    Codes/lots: Serial Numbers: ANAS01357 ANAP00609 ANAQ00988 ANAS00586 ANAR00543 ANAP01088 ANAM00443Quantity: 7 unitsRecall no. Z-3191-2026Class II

  4. 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

    Codes/lots: Serial Numbers: 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 8010783Quantity: 410 unitsRecall no. Z-3192-2026Class II

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

More Medicines & devices recalls