Datex-Ohmeda Panda Freestanding Warmer 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 has initiated a Class I recall of 550 Panda Freestanding Warmer units due to a risk of incorrect oxygen concentration delivery.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 3, 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 is recalling Panda Freestanding Warmer, Infant Radiant Warmer units 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 Panda Freestanding Warmer, Infant Radiant Warmer (product identifier 2063568-001) 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 affected service blender components listed in the recall. The recall number is Z-2359-2026. Distribution pattern is pending.
What You Should Do
Consumers with affected devices should follow guidance from the recalling firm regarding the issue.
Why This Matters
This Class I recall involves a device that may deliver incorrect oxygen levels, posing a serious health risk to patients.
Source
FDA recall Z-2359-2026
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 (1,201 characters here).
Similar severity timing
Same severity (high) notices issued closest in time to August 3, 2026.
Frequently Asked Questions
Common questions about this FDA recall.