Reported Jan 1, 2025 · Ongoing

BYTE Aligner System REF PRS-0063 BYTE All-Day Aligner System BYTE AT-Night Aligner System A custom-made orthodontic…

Straight Smile, LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Straight Smile, LLC · 3301 N Thanksgiving Way · Lehi, UT · 84043-4128

Is this the product you have?

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.

Lot codes and dates: BYTE
All-Day Aligner System Catalog NumberPRS-0063
UDI-DI code00850017524163
Lot NumbersU.S.
2,032 of 2,032 codes
17732803613
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
1550-5987393421
1550-7942491181
1550-8978597191
1551-1922835701
1551-3703690751
1551-4047563861
1551-4819077851
1551-4826159631
1551-6464211451
1551-6492468971
1551-9010332821
1551-9847531111
1552-0753888851
1552-4909407241
1552-6104081791
1552-6878824261
1552-8348951001
1552-9637841291
1553-2183553251
Amount recalled: 5,324,178 devices

Where it was sold

Why it was 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.

This product could cause temporary or reversible health problems — stop using it.

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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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