Agency classClass IOur severity:Severe FDA (Devices)·Z-2359-2026·Announced 2026-06-24

Panda freestanding warmer blender knobs may deliver wrong oxygen concentration

Panda Freestanding Warmers are being recalled because a loosening blender knob shaft can cause delivery of an oxygen concentration that does not match the setting.

The agency’s classification

FDA (Devices): Class I

Class I is 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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class I recall, which the rubric floors at Severe; no injury is reported in the source, so it does not escalate to Critical.

Plain-English summary

The Panda Freestanding Warmer, an infant radiant warmer, product identifier 2063568-001, is being recalled. Devices are impacted only if service blender M1091607-R was installed during the last preventative maintenance. The action covers 550 units, of which 367 are in the United States and 183 outside it.

The stated reason is that the blender knob shaft can loosen, which can affect the delivered oxygen concentration. According to the manufacturer, 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. The FDA classified the action as Class I, its most serious classification.

The recall notice lists distribution as pending. The warmers are installed in healthcare facilities rather than sold to consumers.

Facilities should identify affected units using the product identifier and the service blender UDI-DI 00813841020010 and follow the instructions issued by the manufacturer.

The recalled product

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.
Manufacturer: Datex-Ohmeda Inc
Category: Medical Device — Infant warmer
Hazard: loose-component
oxygen-concentration
hypoxia
hyperoxia
class-i

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 3 recalled by Datex-Ohmeda Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Same manufacturer · Datex-Ohmeda Inc

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