Giraffe Stand-alone Infant Resuscitation System Recall
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Datex-Ohmeda Inc. is recalling 550 units of the Giraffe Stand-alone Infant Resuscitation System due to a blender knob shaft issue that may affect oxygen concentration.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 2, 2026 and geographically references United States. Its severity classification of "high" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
What Happened
Datex-Ohmeda Inc. initiated a voluntary Class I recall of the Giraffe Stand-alone Infant Resuscitation System because the blender knob shaft can loosen, affecting 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.
Which Products Are Affected
The recall affects the Giraffe Stand-alone Infant Resuscitation System (powered emergency ventilator/resuscitator) with product identifiers 2082663-001, 2082663-002, and M1241424. Products are impacted only if service blender M1091607-R was installed during the last preventative maintenance. A total of 550 units (367 US; 183 OUS) are affected. The UDI-DI of the service blender component is 00813841020010. Affected devices were installed with specific serial numbers of the service blender component as listed in FDA recall Z-2357-2026. Distribution pattern is pending.
What You Should Do
Consumers with affected devices should refer to the recall notice from Datex-Ohmeda Inc. for further instructions.
Why This Matters
The recall involves a Class I device where the hazard may result in hypoxia or hyperoxia.
Source
FDA recall number Z-2357-2026, initiated May 8, 2026, by Datex-Ohmeda Inc., Waukesha, WI.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,343 characters here).
Similar severity timing
Same severity (high) notices issued closest in time to August 2, 2026.
Frequently Asked Questions
Common questions about this FDA recall.