Official recall notice

FDA DeviceClass INotable

FDA Recall: Giraffe Stand-alone Infant Resuscitation System; Powered emergency ventilator (resuscitator) Produc

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 →
Share:

Related Recalls

2026-09-23 · FDA_DEVICE
FDA Recall: Aisys CS2 with Et Control, Datex-Ohmeda anesthesia system, Part Number 1011-9000-000
Datex-Ohmeda, Inc.
2026-09-23 · FDA_DEVICE
FDA Recall: Et Control, Software option for anesthesia gas machine to achieve and maintain targeted end tidal ox
Datex-Ohmeda, Inc.
2026-09-23 · FDA_DEVICE
FDA Recall: Aisys CS2, Datex-Ohmeda anesthesia system, Part Number 1011-9055-000
Datex-Ohmeda, Inc.
2026-09-23 · FDA_DEVICE
FDA Recall: Aisys, Datex-Ohmeda anesthesia system, Part Number 1011-9050-000
Datex-Ohmeda, Inc.
Giraffe Stand-alone Infant Resuscitation System Recall (Jun 2026) | WatchRecall