Safety & Regulatory
Important Safety Information
- Tortle® products are intended to be used only as directed.
- Always follow sizing instructions and fitting guidance.
- Inspect the product before each use.
- Discontinue use if the product becomes damaged.
- Consult your pediatrician if you have concerns regarding your child's head shape, positioning, or development.
Safe Sleep Guidance
- Follow all American Academy of Pediatrics (AAP) safe sleep recommendations.
- Place babies on their backs for sleep.
- Use only on a firm, flat sleep surface.
- Keep soft bedding, pillows, blankets, and toys out of the sleep area.
- Follow Tortle fitting instructions at all times.
FDA Clearance
Tortle® Corrective Beanies are FDA-cleared Class I medical devices intended to assist with infant head repositioning as described in product labeling. Tortle products should be used according to all instructions and are not intended to replace professional medical advice.
Medical Disclaimer
The information on this website is provided for educational purposes only and is not medical advice. Parents and caregivers should consult their healthcare provider regarding diagnosis, treatment, or concerns about plagiocephaly, torticollis, or any other medical condition.
Safety & Regulatory Information Tortle® is committed to product safety, regulatory compliance, and evidence-based infant care. Tortle Corrective Beanies are FDA-cleared Class I medical devices designed to assist with infant repositioning when used according to product instructions. Parents and caregivers should always follow safe sleep recommendations and consult their healthcare provider regarding medical concerns. This website is intended for educational purposes and does not provide medical advice. Always read and follow all product instructions before use.