Class I

Medical Device Recall: Panda Freestanding Warmer, Infant Radiant Warmer Product Identifiers: 2063568-001 Impacted only if service blender M1091607-R was installed during the last Preventative Maintenance.

Datex-Ohmeda Inc · May 8, 2026

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.

Distribution

Pending

Quantity Affected

550 (367 US; 183 OUS)

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2359-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.