Giraffe Warmer and Panda Warmer Recall

Source: FDA · United States

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 Giraffe Warmer and Panda Warmer with Integrated 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, medical-devices.

What Happened

Datex-Ohmeda Inc initiated a voluntary recall of certain Giraffe Warmer with Integrated Resuscitation System (iRes) and Panda Warmer with Integrated Resuscitation System (iRes) devices. The 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.

Which Products Are Affected

The recall affects Giraffe Warmer with Integrated Resuscitation System (iRes) and Panda Warmer with Integrated Resuscitation System (iRes) with product identifiers M1118179 and M1112198. Impacted devices are only those where service blender M1091607-R was installed during the last Preventative Maintenance. The UDI-DI of the service blender component is 00813841020010. A total of 550 units are affected (367 US; 183 OUS). Affected devices were installed with specific serial numbers of the service blender components as listed in FDA records. The recall number is Z-2358-2026. Distribution pattern is pending.

What You Should Do

Consumers with affected devices should follow instructions provided in the firm's notification letter. Contact Datex-Ohmeda Inc at the address 3114 N Grandview Blvd, Waukesha, WI 53188-1615 for further information.

Why This Matters

This Class I recall involves a potential risk of hypoxia or hyperoxia due to incorrect oxygen concentration delivery in neonatal warming devices.

Source

FDA recall Z-2358-2026, event ID 99036. https://www.fda.gov

Original source: FDA Official Notice ↗

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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.

Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Datex-Ohmeda Inc is recalling 550 units of Giraffe Warmer and Panda Warmer with Integrated Resuscitation System due to a blender knob shaft issue that may affect oxygen concentration.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "high" severity. Take precautions and monitor for updates.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.