BYTE Aligner System REF PRS-0063 BYTE All-Day Aligner System BYTE… — Class II medical device recall Z-0750-2025
Ongoing recall by Straight Smile, LLC, reported 2025-01-01, distributed nationwide. Virtual-only clinical workflow utilized for dental aligners and impression to approve patients for aligner dev
| Recall number | Z-0750-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Straight Smile, LLC, Lehi, UT, United States |
| Recall initiated | 2024-11-04 |
| Classified | 2024-12-23 |
| Reported by FDA | 2025-01-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU |
| Quantity | 5,324,178 devices |
| UPC / GTIN / UDI-DI | 00850017524163, 00850017524170 |
| Lot numbers | 1541-8760994451, 1543-1100754821, 1543-3414202891, 1543-3432526751, 1543-4235973091, 1543-6917440011, 1543-9520827111, 1544-3697240661, 1544-3701204981, 1544-5456199651, 1544-7224133161, 1544-9091272701, 1544-9711007881, 1545-1892023561, 1545-2829643331, 1545-8723173781, 1546-0149254981, 1546-1844697261, 1546-2431084621, 1546-4535565811, 1546-5302658721, 1547-4352731881, 1547-5049030711, 1548-0962989131, 1548-7930768331, 1548-8608483691, 1549-0109064461, 1549-3476145071, 1549-3914331141, 1549-5604271371, 1549-6288071031, 1549-7431308041, 1549-8157978931, 1549-9114511321, 1549-9463103781, 1550-0849217361, 1550-1755809801, 1550-1808153641, 1550-2472171981, 1550-2742615371 and 460 more |
| Model numbers | PRS-0063 |
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 of the stomatognathic system to correct malocclusions.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0750-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.