Critical Alert
Datex-Ohmeda Inc Recalls Panda Freestanding Warmer
This is a Class I recall — the most serious type. There is a reasonable probability of serious health consequences or death.
Source: FDA
CriticalRecall #Z-2359-2026Medical Device
Datex-Ohmeda Inc Recalls Panda Freestanding Warmer
Datex-Ohmeda Inc · Class I — Most Serious
Product Description
Panda Freestanding Warmer, Infant Radiant Warmer Product Identifiers: 2063568-001 Impacted only if service blender M1091607-R was installed during the last Preventative Maintenance.
Reason for Recall
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.
FDA Classification
Class I — Most Serious
A situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Distribution
Pending
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
The FDA has classified this as a Class I recall — the most serious classification reserved for situations where there is a reasonable probability that use of, or exposure to, the product will cause serious adverse health consequences or death. Datex-Ohmeda Inc initiated this recall of medical device on May 8, 2026 affecting 550 (367 US; 183 OUS). Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The product was distributed in Pending. Consumers who have this product should stop using it immediately and contact the recalling firm.
Sources: FDA openFDA Enforcement Database
This recall appears in: Other Injury Hazards.