Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
BYTE Aligner System REF PRS-0063 BYTE All-Day Aligner System BYTE Recalled by Straight Smile, LLC Due to Virtual-only clinical workflow utilized for dental aligners and...
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 Straight Smile, LLC directly.
Affected Products
BYTE Aligner System REF PRS-0063 BYTE All-Day Aligner System BYTE AT-Night Aligner System A custom-made orthodontic appliance, typically supplied in series intended to be worn in succession and self-changed every few weeks, designed to influence the shape and/or function of the stomatognathic system to correct malocclusions.
Quantity: 5,324,178 devices
Why Was This Recalled?
Virtual-only clinical workflow utilized for dental aligners and impression to approve patients for aligner devices may not be suitable for patients who have certain contraindications.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Straight Smile, LLC
Straight Smile, LLC has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report