The Recall Desk

FDA (Devices) recall action 99036

Datex-Ohmeda Inc recalled 3 products on 2026-06-24

The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2026-06-24
Critical
0
Units
—

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

1–3 of 3

  • SevereFDA (Devices)··2026-06-24

    Giraffe infant resuscitation system may deliver wrong oxygen concentration

    Giraffe Stand-alone Infant Resuscitation Systems are being recalled because a loosening blender knob shaft can cause delivery of an oxygen concentration that does not match the setting.

    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
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2026-06-24

    Panda freestanding warmer blender knobs may deliver wrong oxygen concentration

    Panda Freestanding Warmers are being recalled because a loosening blender knob shaft can cause delivery of an oxygen concentration that does not match the setting.

    Product
    Panda Freestanding Warmer, Infant Radiant Warmer Product Identifiers: 2063568-001 Impacted only if service blender M1091607-R was installed during the last Preventative Maintenance.
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2026-06-24

    Giraffe and Panda warmer blender knobs may deliver wrong oxygen concentration

    Giraffe and Panda Warmers with Integrated Resuscitation System are being recalled because a loosening blender knob shaft can cause delivery of an unintended oxygen concentration.

    Product
    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.
    Category
    Distribution
    0 states