Official recall notice

FDA DeviceClass INotable

FDA Recall: Giraffe Warmer with Integrated Resuscitation System (iRes), Panda Warmer with Integrated Resuscitati

Recall date
2026-06-24
FDA class
Class I

Why it was recalled

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.

Recommended action

What to do

550 (367 US; 183 OUS)

Product 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.

Verify with the official notice →
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