MEDICAL DEVICE RECALLCRITICAL

Giraffe Stand-alone Infant Resuscitation System

Datex-Ohmeda recalls Giraffe infant resuscitation systems over oxygen concentration risk.

What to do

Check if your Giraffe Stand-alone Infant Resuscitation System had service blender M1091607-R installed during the last preventative maintenance. If so, stop using the system and contact Datex-Ohmeda immediately for instructions on inspection and repair.

Recalled

2026-05-08

Listed

2026-06-18

Updated

2026-09-03

Recall No.

Z-2357-2026

Agency

FDA

Firm

Datex-Ohmeda Inc

Recall ID

99036

Status

ONGOING

Recall at a glance

Quantity recalled: 550 (367 US; 183 OUS)

Why it was recalled

Datex-Ohmeda is recalling the Giraffe Stand-alone Infant Resuscitation System because the blender knob shaft can loosen, affecting delivered oxygen concentration and potentially causing hypoxia or hyperoxia in patients. The affected systems are those where service blender M1091607-R was installed during the last preventative maintenance.

Is mine affected?

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

UDI-DI: 00813841020010, 12105790, 7979700385

Product	Recall #
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 Maintenance	Z-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

Timeline

2026-05-08Firm initiated recall
2026-06-18Publicly announced
2026-06-19Listed on Recall Canary
2026-09-03Summary updated

Official source

View on U.S. Food and Drug Administration →

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Editorial summary by Recall Canary · summary updated 2026-09-03 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification