Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Giraffe Omnibed - Product Usage: The OmniBed is a combination Recalled by Ohmeda Medical Due to GE Healthcare has become aware of a potential...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Ohmeda Medical directly.
Affected Products
Giraffe Omnibed - Product Usage: The OmniBed is a combination of an infant incubator and an infant warmer. The device can be operated as an incubator or as a warmer and can transition from one mode to the other on user s demand. It cannot be operated in both modes at the same time. Incubators and warmers 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 and warmers provide infrared heat in an open environment. They may also be used for short periods of time to facilitate the neonate s transition from the uterus to the external environment. This device may incorporate a Servo Controlled Oxygen Delivery System. This is indicated to provide stable oxygen concentration within the infant compartment at the value set by the operator (21-65%).
Quantity: N/A
Why Was This Recalled?
GE Healthcare has become aware of a potential safety issue that can occur if the canopy seals are not cleaned appropriately. Healthcare professionals reported buildup of debris around the edge of the canopy seal which can lead to a source of infection. Upon review, the Agency concluded that the cleaning and care guidelines provided by the firm were inadequate for effective cleaning of the device. In particular, the instructions do not instruct for removal of canopy seal prior to cleaning, which leads to the buildup of debris.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Ohmeda Medical
Ohmeda Medical has 13 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report