Recall database

Aligner, Sequential recalls

Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.

Showing 1–2 of 2 recalls

Class IIOngoingZ-0750-2025

Straight Smile, LLC recalls BYTE Aligner System REF PRS-0063 BYTE All-Day Aligner System BYTE AT-Night Aligner…

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.

Sequential Aligner
Device Design

Straight Smile, LLCUTJan 1, 2025

Class IIOngoingZ-0743-2025

3M Company - Health Care Business recalls Clarity Precision Grip Attachments

Attachments may not mate with the tooth as intended in the digital treatment design.

Sequential Aligner
Software design (manufacturing process)

3M Company - Health Ca…MNJan 1, 2025