CLASS II ONGOING Device recall · Reported 23 Sep 2026 · FDA Enforcement Report
Aisys CS2 with Et Control, Datex-Ohmeda anesthesia system recalled
Datex-Ohmeda is recalling Aisys CS2 with Et Control, 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
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-3191-2026
- 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 with Et Control, Datex-Ohmeda anesthesia system, Part Number 1011-9000-000
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: ANAS01357 ANAP00609 ANAQ00988 ANAS00586 ANAR00543 ANAP01088 ANAM00443
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| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Et Control recalled by Datex-Ohmeda | 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 | Et Control recalled by Datex-Ohmeda | 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 |
Other Other Medical Devices recalls
All 13,817| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Convenience kits Cataract Pack DYNJ59881A recalled by Medline Industries | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Percutaneous Insertion Kit (PIK), dilator set recalled | Maquet Cardiopulmonary | Sterility | Nationwide |
| Device | CLASS II | Blood Culture Collection Venipuncture Kit 20/Cs recalled | Medical Action Industries Inc. 306 | Sterility | Nationwide |
| Device | CLASS II | CADD Yellow Medication Cassette Reservoir with NRFit connector US recalled | ICU Medical | Packaging Defects | Nationwide |
| Device | CLASS II | Aisys, Datex-Ohmeda anesthesia system recalled | Datex-Ohmeda | Device Malfunction | Nationwide |