Invisalign Go Plus 9012Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00816063020431), received between Dec 20, 2023 and May 6, 2026 — classified as 6 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMay 6, 2026Adverse Event Without Identified Device or Use Problem

  THE TREATING DOCTOR REPORTED THAT THE PATIENT HAD SYMPTOMS OF ABSCESSES BETWEEN DIFFERENT TEETH, GRADE II TOOTH MOBILITY, SENSITIVITY, TENDERNESS TO PALPATION AND TOOTH LOSS (TOOTH #1.7). THE PATIENT DID NOT REPORT REQUIRING ANY MEDICAL INTERVENTION FOR THE REPORTED SYMPTOMS. THE PATIENT INDICATED BEING PRESCRIBED ANTIBIOTICS TO ALLEVIATE THE REPORTED SYMPTOMS. IT IS UNKNOWN IF ANY CLINICAL OR LABORATORY TESTS WERE PERFORMED. THE PATIENT IS CURRENTLY REPORTED TO BE GETTING BETTER.

  Patient problems: Abscess; Sensitivity of Teeth; Tooth Loss

  MAUDE report 25094531 ↗
• InjuryFeb 2, 2026Adverse Event Without Identified Device or Use Problem

  THE TREATING DOCTOR REPORTED THAT THE PATIENT REQUIRED EXTRACTION OF TOOTH UR4. IT IS UNKNOWN IF THE PATIENT REQUIRED ADDITIONAL MEDICAL INTERVENTION OR MEDICATIONS TO ALLEVIATE THE REPORTED EVENT. IT IS UNKNOWN WHETHER THE PATIENT DISCONTINUED THE ALIGNERS, AND THE PATIENT'S CURRENT CONDITION IS UNKNOWN.

  Patient problems: Tooth Loss

  MAUDE report 24240247 ↗
• InjuryAug 12, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE TREATING DOCTOR REPORTED THAT THE PATIENT REQUIRED AN URGENT TOOTH EXTRACTION (TOOTH 3.6) AND HAD SYMPTOMS OF PAIN ON THE VESTIBULAR GUM AND PAIN WHEN CHEWING. NO ADDITIONAL INFORMATION OR RECORDS ARE AVAILABLE AT THIS TIME.

  Patient problems: Tooth Loss

  MAUDE report 19968061 ↗
• InjuryMay 10, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE TREATING DOCTOR REPORTED THAT THE PATIENT HAD SYMPTOMS OF SWOLLEN LIPS AND SORE THROAT. THE TREATING DOCTOR REPORTED THAT THE PATIENT REQUIRED THE FOLLOWING MEDICAL INTERVENTION TO ALLEVIATE THE REPORTED SYMPTOMS: PATIENT VISITED THE HOSPITAL. THE PATIENT WAS PRESCRIBED WITH THE FOLLOWING MEDICATION: ADRENALINE INJECTION AND STEROID PILLS. THE TREATING DOCTOR REPORTED THAT THE PATIENT DISCONTINUED THE USE OF THE ALIGNERS ON 04-26-2024 AND IS CURRENTLY ASYMPTOMATIC.

  Patient problems: Sore Throat; Swelling/ Edema

  MAUDE report 19288211 ↗
• InjuryMay 8, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE TREATING DOCTOR REPORTED THAT THE PATIENT HAD SYMPTOMS OF TRAUMA TO TOOTH UR6 WHICH LED TO EXTRACTION. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Tooth Loss

  MAUDE report 19273794 ↗
• InjuryDec 20, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE TREATING DOCTOR REPORTED THAT THE PATIENT HAD SYMPTOM OF TOOTH EXTRACTION OF TOOTH 1.1 BECAUSE IT CRACKED DURING TREATMENT. IT IS UNKNOWN IF THE PATIENT REQUIRED ANY MEDICAL INTERVENTION TO ALLEVIATE THE REPORTED SYMPTOM. IT IS UNKNOWN IF THE PATIENT WAS PRESCRIBED ANY MEDICATION TO ALLEVIATE THE REPORTED SYMPTOM. THE TREATING DOCTOR REPORTED THAT THE PATIENT IS CONTINUING TO USE THE ALIGNERS AND IS CURRENTLY ASYMPTOMATIC.

  Patient problems: Tooth Fracture; Tooth Loss

  MAUDE report 18368421 ↗