The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-1502-2017·Announced 2017-03-29

Ohmeda Giraffe Incubator Recall Due to Power Cord Overheating Risk

Ohmeda Medical is recalling Giraffe Incubators 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 high-risk hazards.

Plain-English summary

Ohmeda Medical is recalling Giraffe Incubators, which are infant incubators designed to provide a controlled temperature environment for neonates who cannot regulate their own body heat. The recall involves 5,993 units distributed worldwide, including 5,080 in the United States and Puerto Rico, and 913 in other countries such as the UK, Canada, and Brazil.

The recall is due to a defect in certain power cords manufactured by Electric-Cord, referred to as 'Taller Bridge' power cords. These cords may overheat where they connect to the wall outlet, which could result in fire, charring, smoke, or sparking. Such conditions could cause thermal injury to patients or staff.

Healthcare facilities should stop using the affected incubators and contact Ohmeda Medical for instructions on how to proceed. The source text does not specify a deadline or a specific method for consumers to report the issue, but immediate cessation of use is implied by the safety hazard.

The recalled product

Product
Giraffe Incubator The Giraffe Incubator is an infant incubator. Incubators provide heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Incubators provide an enclosed temperature controlled environment
Manufacturer
Ohmeda Medical
Category
Medical Device — Infant Incubator
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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