CLASS II ONGOING Device recall · Reported 23 Sep 2026 · FDA Enforcement Report
Et Control recalled by Datex-Ohmeda
Datex-Ohmeda is recalling Et Control, 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
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-3192-2026
- 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
- Medical Software
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
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
Where it was distributed
Worldwide - US Nationwide distribution.
Questions about this recall
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.
Which lots are affected?
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
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 99649This 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 |
|---|---|---|---|---|---|
| CLASS II | Aisys CS2 with Et Control, Datex-Ohmeda anesthesia system recalled | Datex-Ohmeda | Device Malfunction | Nationwide | |
| CLASS II | Aisys CS2, Datex-Ohmeda anesthesia system recalled | Datex-Ohmeda | Device Malfunction | Nationwide | |
| 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 |
|---|---|---|---|---|---|
| Device | CLASS II | Aisys, Datex-Ohmeda anesthesia system recalled | Datex-Ohmeda | Device Malfunction | Nationwide |
| Device | CLASS II | Aisys CS2, Datex-Ohmeda anesthesia system recalled | Datex-Ohmeda | Device Malfunction | Nationwide |
| Device | CLASS II | Aisys CS2 with Et Control, Datex-Ohmeda anesthesia system recalled | Datex-Ohmeda | Device Malfunction | Nationwide |
| Device | CLASS I | Panda Freestanding Warmer, Infant Radiant Warmer Product recalled | Datex-Ohmeda | Device Malfunction | WI |
| Device | CLASS I | Giraffe Warmer with Integrated Resuscitation System (iRes) recalled | Datex-Ohmeda | Device Malfunction | WI |
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| Device | CLASS II | Philips IQon Spectral CT recalled by Philips North America | Philips North America | Device Malfunction | MA |