Aisys CS2, Datex-Ohmeda anesthesia system
Medical device recall Z-3190-2026. Published in FDA’s Enforcement Report on Sep 23, 2026.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Sep 23, 2026. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 140 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Aisys CS2, Datex-Ohmeda anesthesia system, Part Number 1011-9055-000
140 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,439 characters
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 AQDF40369 AQDE40780 AQDE40781 AQDE40782 AQDE40783 AQDE40787 AQDE40788 AQDF40325 AQDF40371 AQDF40372 AQDF40373 AQDE40753 AQDF40312 AQDF40382 AQDF40383 AQDF40384 AQDF40385 AQDF40386 AQDF40387 AQDF40308 AQDF40309 AQDF40310 AQDE40765 AQDE40790 AQDE40792 AQDF40398 AQDF40307 AQDE40766 AQDE40767 AQDE40778 AQDE40770 AQDE40774 AQDE40775 AQDE40776 AQDE40777 AQDE40058 AQDD40417 AQDE40799 AQDE40764 AQDE40800 AQDF40283 AQDF40316 AQDF40317 AQDF40318 AQDF40319 AQDF40320 AQDF40321 AQDF40322 AQDF40323 AQDF40324 AQDF40327 AQDF40414 AQDE40739 AQDE40741 AQDE40742 AQDE40779 AQDF40388 AQDF40389 AQDF40390 AQDF40391 AQDE40737 AQDF40350 AQDF40351 AQDF40352 AQDF40374 AQDF40375 AQDF40376 AQDF40377 AQDF40378 AQDF40379 AQDF40380 AQDF40304 AQDF40381 AQDF40415 AQDF40416 AQDF40417 AQDF40418 AQDF40419 AQDF40420 AQDF40421 AQDE40731 AQDE40732 AQDE40735 AQDF40326
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide - US Nationwide distribution.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Jul 30, 2026.
- FDA classified it on Sep 16, 2026.
- FDA’s Enforcement Report published it on Sep 23, 2026.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Datex-Ohmeda, Inc., of Madison, WI.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.