# FDA recall Z-0750-2025

> **Straight Smile, LLC** · Class II · device recall initiated 2024-11-04.

## 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.

## 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.

## Key facts

- **Recall number:** Z-0750-2025
- **Recalling firm:** Straight Smile, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-11-04
- **Report date:** 2025-01-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lehi, UT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0750-2025

## Citation

> AI Analytics. FDA recall Z-0750-2025. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-0750-2025. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*