CLASS II ONGOING Device recall · Reported 23 Sep 2026 · FDA Enforcement Report

Aisys CS2, Datex-Ohmeda anesthesia system recalled

Datex-Ohmeda is recalling Aisys CS2, Datex-Ohmeda anesthesia system, distributed nationwide in the US. The recall was initiated on 30 Jul 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-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 recalled140 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-3190-2026
FDA event ID: 99649
Recalling firm: Datex-Ohmeda, Madison, WI
Classification: Class II
Status: Ongoing
Recall initiated: 30 Jul 2026
FDA classified: 16 Sep 2026
Reported: 23 Sep 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

30 Jul 2026	Recall initiated by company
16 Sep 2026	Classified by FDA	+48 days
23 Sep 2026	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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

Where it was distributed

Worldwide - US Nationwide distribution.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

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

Where was it sold?

Worldwide - US Nationwide distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 29 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

3 other products · FDA event 99649

This product is part of a recall event; the main page for the event is Aisys CS2 with Et Control, Datex-Ohmeda anesthesia system recalled.

Reported	Class	Recall	Company	Reason	Where
23 Sep 2026	CLASS II	Aisys CS2 with Et Control, Datex-Ohmeda anesthesia system recalled	Datex-Ohmeda	Device Malfunction	Nationwide
23 Sep 2026	CLASS II	Et Control recalled by Datex-Ohmeda	Datex-Ohmeda	Device Malfunction	Nationwide
23 Sep 2026	CLASS II	Aisys, Datex-Ohmeda anesthesia system recalled	Datex-Ohmeda	Device Malfunction	Nationwide

More recalls from Datex-Ohmeda

All 30

Reported	Class	Recall	Company	Reason	Where
23 Sep 2026Device	CLASS II	Aisys, Datex-Ohmeda anesthesia system recalled	Datex-Ohmeda	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS II	Et Control recalled by Datex-Ohmeda	Datex-Ohmeda	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS II	Aisys CS2 with Et Control, Datex-Ohmeda anesthesia system recalled	Datex-Ohmeda	Device Malfunction	Nationwide
24 Jun 2026Device	CLASS I	Panda Freestanding Warmer, Infant Radiant Warmer Product recalled	Datex-Ohmeda	Device Malfunction	WI
24 Jun 2026Device	CLASS I	Giraffe Warmer with Integrated Resuscitation System (iRes) recalled	Datex-Ohmeda	Device Malfunction	WI

Other Other Medical Devices recalls

All 13,817

Reported	Class	Recall	Company	Reason	Where
23 Sep 2026Device	CLASS II	Convenience kits Cataract Pack DYNJ59881A recalled by Medline Industries	Medline Industries	Sterility	Nationwide
23 Sep 2026Device	CLASS II	Percutaneous Insertion Kit (PIK), dilator set recalled	Maquet Cardiopulmonary	Sterility	Nationwide
23 Sep 2026Device	CLASS II	Blood Culture Collection Venipuncture Kit 20/Cs recalled	Medical Action Industries Inc. 306	Sterility	Nationwide
23 Sep 2026Device	CLASS II	CADD Yellow Medication Cassette Reservoir with NRFit connector US recalled	ICU Medical	Packaging Defects	Nationwide
23 Sep 2026Device	CLASS II	Aisys, Datex-Ohmeda anesthesia system recalled	Datex-Ohmeda	Device Malfunction	Nationwide