FDA-Device2026-06-24Class IPROCESSING DEFECT
Datex-Ohmeda Giraffe Infant Resuscitation System recalled for oxygen delivery malfunction risk
OTHERNationwide distribution
Datex-Ohmeda Giraffe resuscitator recalled for oxygen delivery risk
A component in certain Giraffe Stand-alone Infant Resuscitation Systems can loosen during maintenance, causing the device to deliver oxygen at the wrong concentration. Infants may receive too much or too little oxygen, risking serious harm.
- Check if your Giraffe system has service blender model M1091607-R installed
- If affected, verify the blender component serial number against the provided list
- Contact Datex-Ohmeda or your hospital biomedical team for inspection or repair
- Do not use the device if you suspect the blender knob is loose
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.
Sold states
Pending
Affected count
550 (367 US; 183 OUS)
Manufactured in
3114 N Grandview Blvd, Waukesha, WI, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2357-2026More Datex-Ohmeda Inc recalls
- FDA-Device2026-06-24Datex-Ohmeda Giraffe and Panda warmers recalled for oxygen delivery malfunction risk
- FDA-Device2026-06-24Datex-Ohmeda Panda Infant Warmer recalled for oxygen delivery error risk
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