FDA Medical devices recall ·
BYTE Aligner System recall
- Recall number
- Z-0750-2025
- Date
- (initiated November 4, 2024)
- Company / brand
- Straight Smile, LLC
3301 N Thanksgiving Way, Lehi, UT, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 5,324,178 devices
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
BYTE All-Day Aligner System Catalog Number: PRS-0063 UDI-DI code: 00850017524163 Lot Numbers: U.S. 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 1553-2206830171 1553-2207770561 1553-2992105981 1553-3788082031 1553-4691850681 1553-4819545741 1553-6209164371 1553-6356195311 1553-8127560541 1554-1370747371 1554-1428423581 1554-2656842861 1554-5042086951 1554-7281718421 1554-8288641491 1554-8707038231 1555-3544992291 1555-3614935151 1555-3806544901 1555-3834122151 1555-3919827611 1555-6333750931 1555-7778547971 1555-8144440311 1555-9646933391 1556-0762886881 1556-1355725571 1556-22304658
Distribution
Worldwide - U.S. Nationwide distribution including in the states of CO, KS, MI, IL, GA NY, MN, IN, PA, TX, NJ, MS, RI, SD, FL, KY, CA, OR, WI, WY, MA, NC, WA, AR, UT, OH, SC, NM, CT, TN, LA, NE, AL, MO, VA, MD, IA, OK, NV, DE, VT, AZ, RI, HI, WV, NH, MT, AK, ID, Puerto Rico, ME and the countries of Australia.
States: Alaska Alabama Arkansas Arizona California Colorado Connecticut Delaware Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Maine Michigan Minnesota Missouri Mississippi Montana North Carolina Nebraska New Hampshire New Jersey New Mexico Nevada New York Ohio Oklahoma Oregon Pennsylvania Puerto Rico Rhode Island South Carolina South Dakota Tennessee Texas Utah Virginia Vermont Washington Wisconsin West Virginia Wyoming
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0750-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.