Agency classClass IIOur severity:Severe FDA (Devices)·Z-1505-2017·Announced 2017-03-29

Ohmeda Medical Recalls Giraffe Incubators Due to Power Cord Overheating

Ohmeda Medical is recalling Giraffe Incubators because certain power cords may overheat, posing a risk of fire or thermal injury.

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 involves a risk of fire and thermal injury, which aligns with the rubric criterion for 'significant injury/property-damage reports' or high-risk hazards, warranting a Severe classification.

Plain-English summary

Ohmeda Medical is recalling approximately 5,993 Giraffe Incubators, including 5,080 units in the United States and 913 units outside the US. The recall is due to a defect in certain power cords manufactured by Electric-Cord, referred to as 'Taller Bridge' power cords.

The affected power cords could overheat where they connect to the wall outlet. This overheating could result in fire, charring, smoke, or sparking, which could cause thermal injury. The devices are infant incubators used to provide heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology.

The recall covers units distributed worldwide, including the US (nationwide and Puerto Rico), Bahamas, UK, Trinidad & Tobago, Taiwan, Spain, Panama, Netherlands Antilles, Mexico, Lebanon, Japan, Ireland, Honduras, El Salvador, Ecuador, Costa Rica, Colombia, Canada, Brazil, and Venezuela. Consumers and healthcare facilities should stop using the affected power cords and contact Ohmeda Medical for instructions on replacement or repair.

The recalled product

Product: Giraffe Incubator Ohmeda Medical 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. They achieve this by providing an enclosed temperature…
Manufacturer: Ohmeda Medical
Category: Medical Device — Infant Incubator
Hazard: fire
burn-injury
overheating

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 →

Same manufacturer · Ohmeda Medical

See all →

High
Giraffe Omnibed Infant Incubator Recalled for Inadequate Cleaning Instructions
FDA (Devices) · 2019-10-16
High
Ohmeda Medical Recalls Rotating IV Poles Due to Fall Risk
FDA (Devices) · 2018-04-04
Severe
Ohmeda-Ohio CarePlus Incubator Recall Due to Power Cord Overheating Risk
FDA (Devices) · 2017-03-29
Severe
Ohmeda Infant Warmer System Recalled Due to Overheating Power Cords
FDA (Devices) · 2017-03-29
Severe
Ohmeda Infant Radiant Warmers Recalled for Power Cord Overheating Risk
FDA (Devices) · 2017-03-29

Same hazard · fire