Madison, WI, United States
Datex-Ohmeda, Inc. recalls
6 recalls recorded since 2018, most recently on 30 July 2026. 4 are listed as ongoing. Status and classification are as published by the FDA.
Recalls6
Ongoing (FDA)4
Terminated or completed2
Class I (FDA)3
Ongoing Class II Medical devices
- Recall started
- 30 July 2026
- Reason
- 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.
- Distribution
- Worldwide - US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-3191-2026, Z-3192-2026, Z-3190-2026, Z-3189-2026
- Aisys CS2 with Et Control, Datex-Ohmeda anesthesia system, Part Number 1011-9000-000
- 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
- Aisys CS2, Datex-Ohmeda anesthesia system, Part Number 1011-9055-000
- Aisys, Datex-Ohmeda anesthesia system, Part Number 1011-9050-000
Ongoing Class I Medical devices
- Recall started
- 8 May 2026
- Reason
- Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver an oxygen concentration that does not match the intended concentration set by the user, potentially resulting in hypoxia or hyperoxia in the patient.
- Distribution
- Pending
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2357-2026, Z-2358-2026, Z-2359-2026
- Giraffe Stand-alone Infant Resuscitation System; Powered emergency ventilator (resuscitator) Product identifiers: 2082663-001, 2082663-002, M1241424 Product impacted only if service blender M1091607-R was installed d
- Giraffe Warmer with Integrated Resuscitation System (iRes), Panda Warmer with Integrated Resuscitation System (iRes) Product Identifiers: M1118179, M1112198 Impacted only if service blender M1091607-R was installed duri
- Panda Freestanding Warmer, Infant Radiant Warmer Product Identifiers: 2063568-001 Impacted only if service blender M1091607-R was installed during the last Preventative Maintenance.
Ongoing Class I Medical devices
- Recall started
- 12 July 2024
- Reason
- Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Aland Islands, ALBANIA, Algeria, Argentina, Australia, Austria, Azerbaijan, BAHAMAS, Bahrain, Bangladesh, BARBADOS, BELARUS, Belgium, Benin, Bermuda, Bolivia, BONAIRE, Bosnia and Herzegovina, Brazil, Brunei, Bulgaria, Cambodia, Cameroon, Ca
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0083-2025, Z-0075-2025, Z-0080-2025, Z-0082-2025, Z-0081-2025, Z-0074-2025, Z-0078-2025, Z-0079-2025, Z-0076-2025, Z-0084-2025, Z-0077-2025
- Aisys CS2 with Et Control. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in th
- Aespire 100. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administrati
- Avance CS2 and Avance CS2 Pro. These anesthesia gas machines are intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualifie
- Aisys CS2. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration
- Aisys. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of
- Aespire 7100, 7100 (Variant), and Aespire 7100 S/5 Protiva configurations. These anesthesia gas machines are intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only b
- Avance. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of
- Amingo. OUS only.
- and 3 more product lines
Ongoing Class I Medical devices
- Recall started
- 29 December 2023
- Reason
- GE HealthCare has become aware of elevated levels of formaldehyde when the EVair or EVair 03 (Jun-Air) optional compressors are used with the CARESCAPE R860 or Engstr¿m Carestation/Pro ventilators, respectively. These elevated results were observed in preliminary testing that was conducted at an elevated room temperature of 40oC (104oF), at the lowest possible flow condition of 2 L/min (worstcase, minimum bias flow with no additional ventilation), and all of the gas being supplied from the compressor (i.e., FiO2 of 21% / no supplemental oxygen). GE HealthCare is continuing to evaluate the root cause for these elevated levels of formaldehyde. While these test conditions are not representative of typical clinical use conditions,GE HealthCare is taking this action to further reduce the potential for patient exposure.
- Distribution
- Worldwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0775-2024, Z-0776-2024, Z-0774-2024
- EVair 03 (Jun-air) air compressor, model numbers: 1609000 and 1609002
- EvAir CPRSR Kit Upgrade: a) DISS/CEE 7/7 230V 50/60 HZ, Model Number M1230849; b) DISS/NEMA 5-15 115V 60 HZ, Model Number M1230847; c) NIST/BS 1363 230V 50/60 HZ, Model Number M1230849; d) NIST/BS 546 230V 50/60
- EVair air compressor, model numbers: M1230849 and M1230847
Terminated Class II Medical devices
- Recall started
- 28 June 2018
- Terminated
- 22 February 2019
- Reason
- The Neonatal Flow Sensor Cable may be missing the connector housing exposing the wires in the cable.
- Distribution
- Worldwide Distribution: US (nationwide) to: Washington, DC and countries of: Algeria, Bangladesh, Brazil, Chile, China, Colombia, Germany, Greece, Guatemala, Honduras, India, Indonesia, Iran, Iraq, Italy, Kenya, Lebanon, Malaysia, Maldives, Mexico, Morocco, Myanmar, Nepal, Netherlands, Nigeria, Pa
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2738-2018
- The Neonatal Flow Sensor Cable used on devices CARESCAPE R860, ENGSTROM CARESTATION, ENGSTROM PRO and contained in Neonatal Software Upgrade Kit 2080496-010. The CARESCAPE R860 ventilator is designed to provide mecha
Terminated Class II Medical devices
- Recall started
- 8 December 2017
- Terminated
- 29 April 2021
- Reason
- Potential for the display processor to experience an unexpected failure.
- Distribution
- Worldwide Distribution - USA (nationwide) Distribution to the states of : AL, AZ, CA, GA, ID, IL, IN, MS, NC, NJ, NK, NV, OH, OK, RI, TX, and WI., and to the countries of : Albania, Argentina, Australia, Bahrain, Bangladesh, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2266-2018
- CARESCAPE R860 ventilators with software version 10SP05 Product Usage: The CARESCAPE R860 ventilator is designed to provide mechanical ventilation or support to neonatal, pediatric, and adult patients weighing 0.25 k
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.