BYTE Aligner System Recalled for Virtual-Only Approval Workflow Gaps
Straight Smile LLC is recalling BYTE Aligner systems due to a virtual-only clinical workflow that may not adequately screen patients with contraindications for aligner use. Approximately 5.3 million devices are affected.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses, injuries, or hospitalizations. The hazard is a workflow limitation that may be unsuitable for certain patients, representing a theoretical risk rather than documented harm. No specific contraindications or incidents are described in the source.
Plain-English summary
The BYTE Aligner System, manufactured by Straight Smile LLC, is a custom-made orthodontic appliance supplied as a series of aligners designed to correct tooth misalignment. The product includes the BYTE All-Day Aligner System and BYTE AT-Night Aligner System with catalog number PRS-0063. Approximately 5,324,178 devices are affected by this recall.
The FDA has classified this as a Class II recall. The company uses a virtual-only clinical workflow to assess patient impressions and approve candidates for aligner treatment. This workflow may not be suitable for patients who have certain contraindications that would make aligner therapy inappropriate. As a result, some patients with contraindications may have been approved for treatment when clinical assessment should have excluded them.
The affected devices have been distributed worldwide, including throughout all U.S. states, Puerto Rico, and Australia.
Patients currently using BYTE aligners should consult their orthodontist or dental provider to discuss whether their treatment remains appropriate for their individual circumstances. Healthcare providers should review patient selection protocols and determine whether any existing patients may need clinical re-evaluation to confirm suitability for continued aligner use.
The recalled product
- Product
- 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…
- Manufacturer
- Straight Smile, LLC
- Category
- Medical Device — Orthodontic
- Affected units
- 5,324,178
Distribution
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