The Recall Desk
SevereFDA (Devices)·Z-2357-2026·Announced 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.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class I recall, which the rubric floors at Severe; no injury is reported in the source, so it does not escalate to Critical.

Plain-English summary

The Giraffe Stand-alone Infant Resuscitation System, a powered emergency ventilator, product identifiers 2082663-001, 2082663-002 and M1241424, is being recalled. Product is impacted only if service blender M1091607-R was installed during the period identified in the recall notice. The action covers 550 units, of which 367 are in the United States and 183 outside it.

The stated reason is that the blender knob shaft can loosen, which can affect the delivered oxygen concentration. According to the manufacturer, 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 FDA classified the action as Class I, its most serious classification.

The recall notice lists distribution as pending. The systems are installed in healthcare facilities rather than sold to consumers.

Facilities should identify affected units using the product identifiers and the service blender UDI-DI 00813841020010 and follow the instructions issued by the manufacturer.

The recalled product

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
Datex-Ohmeda Inc
Category
Medical Device — Infant resuscitation system
Hazard

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 3 recalled by Datex-Ohmeda Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Related recalls

Same manufacturer · Datex-Ohmeda Inc

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Same hazard · loose component

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