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Giraffe Stand-alone Infant Resuscitation System Blender Knob
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MEDICAL DEVICE RECALLCRITICAL

Giraffe Stand-alone Infant Resuscitation System Blender Knob

Datex-Ohmeda recalls Giraffe Infant Resuscitation System over blender knob that may cause incorrect oxygen delivery.

What to do

Immediately stop using the affected device and contact Datex-Ohmeda for a free replacement of the blender knob assembly. Do not use the device until the repair is completed.

Posted
Updated
Recall No.
Z-2357-2026
Agency
Firm
Datex-Ohmeda Inc
Recall ID
99036
Status
ONGOING

Why it was recalled

Datex-Ohmeda is recalling the Giraffe Stand-alone Infant Resuscitation System because the blender knob shaft can loosen, causing the delivered oxygen concentration to differ from the user-set level. This may lead to hypoxia or hyperoxia in the infant patient. Only units where service blender M1091607-R was installed during the last preventive maintenance are affected.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

UPC: 00813841020010, 12105790, 7979700385

ProductRecall #
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.Z-2358-2026
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 MaintenanceZ-2357-2026
Panda Freestanding Warmer, Infant Radiant Warmer Product Identifiers: 2063568-001 Impacted only if service blender M1091607-R was installed during the last Preventative Maintenance.Z-2359-2026
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Editorial summary by Recall Canary · last updated 2026-07-28 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification