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Datex-Ohmeda Inc recalls Giraffe Stand-alone Infant Resuscitation System; Powered emergency ventilator (resuscitator) Product identifiers: 20826
Recalled June 24, 2026 · FDA recall Z-2357-2026 · 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 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 during the last Preventative Maintenance
Manufacturer(s)
Datex-Ohmeda Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →