Recall Z-2359-2026— Datex-Ohmeda Inc

Name: FDA recall Z-2359-2026
Creator: U.S. Food and Drug Administration
Published: 2026-05-08

Class I · Ongoing

Class I FDA medical device recall by Datex-Ohmeda Inc, initiated 2026-05-08. It names one FDA 510(k) clearance: K123309. Product: 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: 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..

Recalling firm: Datex-Ohmeda Inc
Classification: Class I
Status: Ongoing
Initiated: 2026-05-08
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K123309 — GIRAFFE AND PANDA WARMERSOhmeda Medical·cleared 2013-02-05

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.