Recall archive / FDA device enforcement
BYTE Aligner System REF PRS-0063 BYTE All-Day Aligner System BYTE AT-Night Aligner System A custom-made orthodontic a... — FDA record Z-0750-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Nov 4, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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
- 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.
- Classification
- Class II
- Recalling firm
- Straight Smile, LLC
- Quantity
- 5,324,178 devices
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0750-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 1556-2230465841 1556-2330493811 1556-7458327891 1556-8306741391 1556-8975364901 1556-9136131491 1556-9683523151 1556-9785712361 1557-0633333971 1557-0786471341 1557-2521467831 1557-5035066281 1557-5376071891 1557-5533727181 1557-6908739091 1557-6947760051 1557-7793290501 1557-7798446801 1557-7849841961 1557-8153394341 1558-3110394071 1558-3129845601 1558-6256910061 1558-6278187251 1558-7110412931 1558-7199597371 1558-8205199651 1558-8219047301 1558-8399027481 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1578-0503341901 1578-0596128801 1578-0955711311 1578-1578858121 1578-1592793441 1578-1657068281 1578-1754835731 1578-1831566341 1578-2497323051 1578-2600051011 1578-3120102221 1578-3293397711 1578-3401199261 1578-3562124191 1578-3646050401 1578-3751992441 1578-4235471801 1578-4348583281 1578-4477608161 1578-4538012561 1578-5041226901 1578-5107054371 1578-5190665731 1578-5289166501 1578-5410284701 1578-5786962131 1578-5789768311 1578-6651393051 1578-6665106981 1578-6740019281 1578-8738931251 1578-9391833661 1578-9698530791 1578-9724599681 1578-9736795381 1578-9746635201 1578-9840867021 1579-0390503311 1579-0431047691 1579-0493456181 1579-0556242071 1579-0742823451 1579-1118481241 1579-1398825981 1579-1434461491 1579-1970935901 1579-2061409981 1579-2190303241 1579-2213301621 1579-2501199071 1579-2670118211 1579-2870116741 1579-3496546401 1579-3636802181 1579-5655863311 1579-5734533901 1579-6222947871 1579-6404483521 1579-6427173441 1579-6611502971 1579-7028567601 1579-7504967791 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1580-7825557341 1580-8562484831 1580-8779944941 1580-8824730491 1580-9053884161 1580-9440977061 1580-9516199941 1581-0017811991 1581-0020934081 1581-0361785161 1581-0402338371 1581-0405073201 1581-0628786221 1581-1088088471 1581-1130606661 1581-1153919401 1581-1410647711 1581-1461054331 1581-1997793031 1581-2020759791 1581-2066819871 1581-2311606341 1581-2490318531 1581-2659051501 1581-2777853931 1581-2810633441 1581-2920723741 1581-3366457571 1581-3370057591 1581-3612650721 1581-3687329151 1581-3815784191 1581-3865131621 1581-3949574971 1581-4000266701 1581-4546260391 1581-4646937771 1581-4826350741 1581-5176019761 1581-5232603161 1581-5256400051 1581-5313040671 1581-5636531291 1581-5677591561 1581-5957348361 1581-6172317661 1581-6177837551 1581-6284588571 1581-7038048401 1581-7056153801 1581-7113273501 1581-7161043271 1581-7185786151 1581-7193127421 1581-7735808641 1581-7801226511 1581-7844151001 1581-7916771001 1581-7939466041 1581-7944710071 1581-8073280261 1581-8179398301 1581-8258088791 1581-8325056521 1581-8662226281 1581-8797180651 1581-8854436391 1581-8960441421 1581-9263804871 1581-950218043... |
The agency lot list is longer than this excerpt. Read the complete list at the official source.
Match all identifying details in the current notice. A brand name alone is not enough.
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 below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- 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
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Jan 1, 2025
- Recall initiation date
- Nov 4, 2024
- Center classification date
- Dec 23, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.