FDA · Class II · September 23, 2026
Illustration: An FDA laboratory that tests medical devices – not the recalled product. Photo: U.S. Food and Drug Administration, public domain.
Datex-Ohmeda recall: Aisys, Datex-Ohmeda anesthesia system, Part Number 1011-9050-000 and 3 more products
Datex-Ohmeda, Inc. is recalling Aisys, Datex-Ohmeda anesthesia system, Part Number 1011-9050-000 and 3 more products – 475 units; 140 units; 7 units; 410 units. The U.S. Food and Drug Administration published the recall on September 23, 2026; it began on July 30, 2026. Distributed nationwide.
Serious Class II means the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
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| Product | Aisys, Datex-Ohmeda anesthesia system, Part Number 1011-9050-000 and 3 more products |
| Brand | Datex-Ohmeda |
| Company | Datex-Ohmeda, Inc. |
| Type | Medical devices |
| Classification | Class II |
| Recall date | July 30, 2026 |
| Published by FDA | September 23, 2026 |
| Quantity | 475 units; 140 units; 7 units; 410 units |
| Recall ID | 99649 |
As listed by FDA
Recalled products (4)
- Aisys, Datex-Ohmeda anesthesia system, Part Number 1011-9050-000
- FDA recall number
- Z-3189-2026
- Codes, lots and dates
- 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 APWF00320 APWF00321 APWF00322 APWF00323 APWF00324 APWF00325 APWE01994 APWE01996 APWE01997 APWF00151 APWF00152 APWF00153 APWF00154 APWF00457 APWD01692 APWF00407 APWE00534 APWF00194 APWF00326 APWF00327 APWF00328 APWF00329 APWF00330 APWF00331 APWF00332 APWF00333 APWF00334 APWF00335 APWY01203 APWC01449 APWF00369 APWF00305 APWF00307 APWX01221 APWY02445 APWC02036 APWF00340 APWC01226 APWF00361 APWF00362 APWF00399 APWF00400 APWF00401 APWF00112 APWV01020 APWC01174 APWE01441 APWF00134 APWF00135 APWF00136 APWT00828 APWC02088 APWC01284 APWV02602 APWF00263 APWF00264 APWF00265 APWF00266 APWF00267 APWF00268 APWF00269 APWF00270 APWF00271 APWF00272 APWC02592 APWU00484 APWF00360 APWF00494 APWF00495 APWT02203 APWF00291 APWF00482 APWE02001 APWE02002 APWE02003 APWD00679 APWE02013 APWE02018 APWE02024 APWE02025 APWE01966 APWE01970 APWF00195 APWF00409 APWE01987 APWE01988 APWF00336 APWF00417 APWF00414 APWE02036 APWE02037 APWE02038 APWC01196 APWC01199 APWF00166 APWF00167 APWF00168 APWC01206 APWC01221 APWC01198 APWF00337 APWF00338 APWF00347 APWF00348 APWF00187 APWF00188 APWF00106 APWF00373 APWF00374 APWF00376 APWF00377 APWF00378 APWF00392 APWF00393 APWF00394 APWF00412 APWF00366 APWF00367 APWF00370 APWF00371 APWF00372 APWF00375 APWF00391 APWF00410 APWF00411 APWF00413 APWF00119 APWT00259 APWT00260 APWT00262 APWZ01081 APWE01969 APWF00113 APWF00159 APWF00160 APWF00161 APWF00162 APWF00164 APWW01662 APWE01932 APWV00241 APWV00250 APWV00264 APWF00196 APWF00139 APWF00165 APWF00345 APWE01892 APWE01893 APWE01894 APWE01896 APWE01980 APWE01981 APWF00379 APWF00236 APWE01901 APWE01913 APWE02043 APWF00508 APWF00509 APWE01982 APWE01984 APWE01985 APWE02009 APWF00201 APWC01326 APWF00205 APWF00206 APWF00365 APWE01993 APWE01975 APWE01976 APWF00415 APWF00416 APWE01979 APWE01991 APWE01992 APWY00450 APWT00103 APWF00202 APWF00203 APWF00133 APWF00261 APWF00176 APWF00175 APWF00177 APWE02063 APWF00229 APWF00142 APWF00343 APWF00344 APWF00156 APWF00158 APWF00425 APWF00428 APWF00430 APWF00426 APWF00427 APWF00429 APWF00431 APWF00115 APWF00228 APWF00137 APWF00127 APWF00128 APWF00129 APWF00130 APWF00131 APWE01978 APWE01904 APWE01917 APWS00366 APWF00199 APWF00200 APWE01953 APWE01954 APWE01955 APWE01959 APWF00273 APWF00275 APWF00276 APWF00277 APWF00278 APWE01986 APWE02067 APWF00292 APWF00293 APWE02069 APWC01061 APWC01078 APWE02006 APWF00118 APWF00314 APWF00315 APWF00215 APWF00216 APWF00217 APWF00218 APWF00219 APWF00444 APWF00445 APWF00446 APWF00447 APWF00448 APWE01899 APWE01897 APWF00116 APWF00117 APWF00408 APWE01977 APWF00125 APWF00126 APWF00185 APWF00186 APWF00124 APWF00341 APWF00342 APWF00450 APWF00451 APWF00452 APWF00453 APWF00454 APWF00455 APWF00209 APWF00210 APWF00211 APWF00212 APWF00213 APWF00384 APWF00227 APWE01872 APWF00232 APWF00443 APWF00363 APWF00364 APWF00198 APWF00108 APWF00109 APWF00110
- Quantity
- 475 units
- Classification
- Class II
- Aisys CS2, Datex-Ohmeda anesthesia system, Part Number 1011-9055-000
- FDA recall number
- Z-3190-2026
- Codes, lots and dates
- 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
- Quantity
- 140 units
- Classification
- Class II
- Aisys CS2 with Et Control, Datex-Ohmeda anesthesia system, Part Number 1011-9000-000
- FDA recall number
- Z-3191-2026
- Codes, lots and dates
- Serial Numbers: ANAS01357 ANAP00609 ANAQ00988 ANAS00586 ANAR00543 ANAP01088 ANAM00443
- Quantity
- 7 units
- Classification
- Class II
- 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
- FDA recall number
- Z-3192-2026
- Codes, lots and dates
- 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 801078342-5 801078342-6 801078342-7 801078342-8 801078342-9 801102924 801108227 801113705 801114965 801084897 801003006 801004394 801071735 801016238 801050584 801051585 801064585 801013238 801013095 801043259 801088072 801014199 801006762 801052860 801023283 801110573 801064058 801080036 801126195 801064184-1 801064184-2 801059320-1 801059320-2 801091614 801028252 801051344 801030002 800988180 801111226 801028748 801054482 801090144 801083490 801105951 107945491 801101919 801121340 801038810 801053994 801105562 801119480 801049728 801078062-1 801078062-2 801089690-1 801089690-2 801115703-1 801115703-2 801016353 801019099 801041178 801052685 801081089 801126428 800998007-1 800998007-2 801078509-1 801078509-2 801118676-1 801118676-2 801096089 801101334-1 801101334-2 801100493 801039330 801041393 801055432 801119046 801115340 801040296 801111527 801009694 801030435 801061340 801068616 801044691 800992967 801000463 801000846 801013160 801019318 801050351 801058964 801072530 801084650 801123546 801132989 801107094 801073112 801028803-1 801082191 801069983 801117417 801015409 801052571 801015260 801072302-1 801072302-2 801085278 801025248 108226503-1 801051355 801027603 801109512 800997483 801081637 801042760 107906045-1 108053916-1 108053916-2 108224454-1 801086379 801135413 801013416 801028564 801127004 801008246 801012604 801027426 801074100 801088290 310236371 310236376 310240041 310240042 310240043 310242155 310241679 107918076 107919759 310236689 310241141 310241142 310241658 310241953 310234680 310236385 310236881 310237046 310241289 801093641 801034872-1 801034872-2 801034872-3 801048558-1 801048558-2 81544624 81546632-1 81546632-2 81546632-3 81546632-4 81546632-5 81550679-1 81550679-2 81550679-3 81550679-4 81551858-1 81551858-2 81551858-3 801085315 70527837 801059221 70526890 20033613 20034085 20034430-1 20034430-2 20034430-3 70508471 70525803-1 70525803-2 801053404 800992445 801056524 801072691 801036894 801123908 801060720 801003319 801119746 801019081 801085003 801007902 801053051 801061826 801000673-1 801000673-2 801071631-1 801071631-2 801071631-3 801011825 108073330-1 801074634-1 801074634-2 800998014-1 800998014-2 801066810 801027126 801057455 801086239 801109955 801067617-1 801067617-2 801067617-3 801043199 800999253-1 800999253-2 801065015-1 801065015-2 81550411-1 81550411-2 81547645 81548286 81548650 81549748 81546813-1 81546813-2 801105752 81547967 81545881 39047961 107841136 107861401 107941857 107978351 107978475 108105559 81552791-1 81552791-2 801105767 801111863 81553009 81545887 81548567 81550067 81552682-1 81552682-2 81552682-3 108189840 81552497 801014486 801068830 801068831 801044090 801049548 800989605 801007031 801022388 801040963 801094621 801105680 800988523-1 800988523-2 81550139-1 81550139-2 81550139-3 81550139-4 81550139-5 81546491 81552328 801087814 800991563-1 800991563-2 800991563-3 800991563-4 800991563-5 801088958-1 801088958-2 107851114 108186429 81552638 81546199 81549183-1 81549183-2 81549183-3 801131977 801000718 320035726 81552996-1 81552996-2 81551978 81544458 81546083 81552327 801106164 801064461 801112471 801118143 801005425-1 801005425-2 801005425-3 801049573 81552775 81545621-1 81545621-2 801085518-1 801085518-2 801085518-3 801085518-4 801085518-5 81548295 81549346 81546934-1 81546934-2 81546934-3 81546934-4 81546934-5 81548096-1 81548096-2 81548096-3 81549668-1 81549668-10 81549668-2 81549668-3 81549668-4 81549668-5 81549668-6 81549668-7 81549668-8 81549668-9 81550123-1 81550123-2 81550123-3 81550123-4 81550123-5 323010347 801095588-1 801095588-2 800989609 801014580 801027881 801050682 801050687-1 801050687-2 801083571-1 801083571-2 801105662-1 801105662-2 99019578 107906890 81550828 81551765 99019574 800991680 801080524 800997072 800998893 801050798 801081436 108207332 801009250 801041678 801079409
- Quantity
- 410 units
- Classification
- Class II
Exactly as the agency lists them
Identifiers and details
- FDA event ID
- 99649
- Initiated
- Voluntary: Firm initiated
- Status
- Ongoing
- Firm location
- Madison, WI, United States
Why it was recalled
The reason the FDA lists: “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.”
Where it was sold
Nationwide. Distribution as the FDA records it: “Worldwide - US Nationwide distribution.”
What to do
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Official notice: FDA Enforcement Report record (event 99649, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.
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FAQ
About this recall
Is Datex-Ohmeda Aisys, Datex-Ohmeda anesthesia system, Part Number 1011-9050-000 recalled?
Yes. Datex-Ohmeda, Inc. recalled it on July 30, 2026; FDA published it September 23, 2026 (Class II). Only the lots, dates or models listed on this page are included.
Why was it 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.
What should I do if I have it?
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Where was it sold?
Nationwide.
Recalls
More recalls
Source: recall records published by the U.S. Food and Drug Administration (openFDA Enforcement Reports), the USDA Food Safety and Inspection Service, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, collected twice a day. Product names, lot codes, dates and model numbers are shown exactly as the agency lists them; the agency's notice is the authority. 77.today is not affiliated with any of these agencies.