Aisys, Datex-Ohmeda anesthesia system
Medical device recall Z-3189-2026. 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
- 475 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, Datex-Ohmeda anesthesia system, Part Number 1011-9050-000
475 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 2,000 characters
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 APWF00312 APWX00800 APWX00804 APWF00138 APWF00466 APWE01974 APWF00396 APWF00297 APWF00298 APWF00299 APWF00300 APWF00296 APWT00798 APWA02035 APWF00239 APWF00241 APWF00242 APWF00243 APWF00244 APWF00245 APWF00246 APWF00247 APWF00248 APWF00249 APWF00250 APWF00251 APWF00252 APWF00253 APWF00254 APWF00255 APWF00256 APWF00405 APWF00406 APWF00459 APWF00145 APWF00146 APWF00147 APWF00149 APWF00150 APWF00346 APWE02051 APWE02057 APWE02058 APWE02059 APWE01912 APWF00308 APWF00309 APWE01990 APWW00228 APWU01342 APWE01989 APWT00240 APWZ00855 APWF00395 APWF00339 APWX02985 APWX02993 APWF00190 APWE01968 APWC01311 APWF00456 APWY01027 APWY01033 APWY01034 APWE01960 APWF00197 APWE01972 APWE01973 APWC01482 APWF00304 APWE01933 APWE01935 APWF00460 APWZ01205 APWF00237 APWE01998 APWE01999 APWE01971 APWF00179 APWF00180 APWF00181 APWF00182 APWF00183 APWD02593 APWD02605 APWC03541 APWF00294 APWF00311 APWV02707 APWV02725 APWV02729 APWC02024 APWC02122 APWT02371 APWF00220 APWF00221 APWF00222 APWF00223 APWF00224 APWF00225 APWF00226 APWF00155 APWE01967 APWY02790 APWC01093 APWF00397 APWF00398 APWF00184 APWC01293 APWC01297 APWB01830 APWW01733 APWF00358 APWU02297 APWU02303 APWF00257 APWF00258 APWF00259 APWE01995 APWF00301 APWF00302 APWF00303 APWZ01218 APWE01821 APWE01823 APWE01887 APWE01888 APWE01889 APWE01890 APWE01891 APWC01262 APWC01292 APWV01345 APWF00207 APWF00208 APWF00238 APWF00316 APWF00317 APWF00318 APWF00319…
FDA’s list runs to 4,789 characters. The first part is shown; the rest is on FDA’s record.
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.”
- FDA’s list of codes runs to 4,789 characters; the first part is shown here, and the rest is on FDA’s record.
- 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
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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.