Health Canada's sampling and evaluation program has determined that the Mombella Mini Mushroom Soothing Teether is a pacifier and does not meet the requirements of the Pacifiers Regulations . Specifically, t he guard or shield of the pacifier can block the airway of the user, posing a suffocation hazard to young babies and children. As of December 23, 2022, the company has received no reports of injuries or incidents in Canada. For tips on safe pacifier use, see Health Canada's web page Is Your Child Safe? and click on Pacifiers.