FDA Medical devices recall ·
Et Control, Software option for anesthesia gas machine to achieve and… recall
- Recall number
- Z-3192-2026
- Date
- (initiated July 30, 2026)
- Company / brand
- Datex-Ohmeda, Inc.
3030 Ohmeda Dr, Madison, WI, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 410 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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
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 you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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 8
Distribution
Worldwide - US Nationwide distribution.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-3192-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.