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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.

Class I
Recalling firm
Datex-Ohmeda Inc
Reason for recall
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 pattern
Pending
State
WI
Status
Ongoing
Recall number
Z-2358-2026
Recall initiated
May 8, 2026
View on openFDA