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Datex-Ohmeda Inc recalls Giraffe Warmer with Integrated Resuscitation System (iRes), Panda Warmer with Integrated Resuscitation System (iRes) Pro
Recalled June 24, 2026 · FDA recall Z-2358-2026 · Datex-Ohmeda
Hazard
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. · FDA Class I
Units
550 (367 US; 183 OUS)
Sold at
Pending
Description
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.
Product
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 during the last Preventative Maintenance.
Manufacturer(s)
Datex-Ohmeda Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →