The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-1507-2017·Announced 2017-03-29

Ohmeda Infant Warmers Recalled Due to Power Cord Overheating Risk

Ohmeda Medical is recalling Giraffe and Panda infant radiant warmers because certain power cords may overheat, posing a fire or thermal injury risk.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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: The recall is classified as FDA Class II and involves a risk of fire and thermal injury, which aligns with the 'Severe' criteria for significant injury reports or structural defects.

Plain-English summary

Ohmeda Medical is recalling specific Giraffe Bedded Warmers and Panda Warmers. The recall involves a modification to the uninterruptible power supply for these infant radiant warmers, which provide infrared heat to neonates who cannot regulate their own body temperature.

The recall is necessary because certain power cords manufactured by Electric-Cord, referred to as 'Taller Bridge' power cords, could overheat. This overheating can occur where the power cord connects to the wall outlet and may result in fire, charring, smoke, or sparking, which could cause thermal injury.

The affected units were distributed worldwide, including in the United States (nationwide and Puerto Rico), the Bahamas, and internationally to the UK, Trinidad & Tobago, Taiwan, Spain, Panama, Netherlands Antilles, Mexico, Lebanon, Japan, Ireland, Honduras, El Salvador, Ecuador, Costa Rica, Colombia, Canada, Brazil, and Venezuela. A total of 5,993 units are affected, with 5,080 in the US and 913 outside the US. Users should stop using the affected power cords and contact Ohmeda Medical for instructions on the modification.

The recalled product

Product
Giraffe Bedded Warmer, Panda Warmer Modification to Giraffe and Panda Warmers (Giraffe and Panda Uninterruptible Power Supply) - Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology.…
Manufacturer
Ohmeda Medical
Category
Medical Device — Infant Radiant Warmers
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • See Attached Spreadsheat

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 11 recalled by Ohmeda Medical 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 11 products in this recall →

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