NuMe 9005Recalls & reported problems
Align Technology, Inc. · Sequential Aligner · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00816063020233), received between Jul 23, 2019 and Jul 23, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (1 report).
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
Device problems
- Patient-Device Incompatibility1
Patient problems
- Diarrhea1
- Dizziness1
- Fatigue1
- Fever1
- Swelling1
- Vomiting1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 23, 2019Patient-Device Incompatibility
AFTER ABOUT FOUR HOURS I BEGAN TO EXPERIENCE SEVERE NAUSEA, EXTREME DIZZINESS. I REMOVED THE PRODUCT (FOR VOMIT AND CLEAN) AND AFTER 4/5 HRS I STARTED FEELING BETTER. NOT HAVING ASSOCIATED THE PROBLEM TO THE DEVICE, I WORE IT AGAIN AND AFTER 4 HRS THE SAME SYMPTOMS RECURRED AND IN ADDITION: VOMITING, SWELLING OF THE TONGUE, DIARRHEA, FEVER RESOLVED WITH 60MG OF DEFLAZACORT FOR TWO DAYS. WITH CONSEQUENT STRONG ASTHENIA, LACK OF APPETITE. THE SYMPTOMS SUBSIDED 24 HRS AFTER THE PRODUCT WAS REMOVED. FDA SAFETY REPORT ID# (B)(4).
Patient problems: Diarrhea; Dizziness; Fatigue; Fever; Swelling; Vomiting
MAUDE report 8821898 ↗
Other Aligner, Sequential devices
- Byte Day Alignes HBYTETrayStraight Smile LLC · Aligner, Sequential1 recall6,719 reports
- Byte Night Aligners NBYTETrayStraight Smile LLC · Aligner, Sequential1 recall6,053 reports
- sequential aligner 100-0352Access Dental Lab, LLC · Aligner, Sequential322 reports
- Invisalign System - Comprehensive 9000Align Technology, Inc. · Aligner, Sequential239 reports
- SureSmile® 1000Orametrix, Inc. · Aligner, Sequential134 reports
- REFINEMENT CORRECTION KIT 100-0012Access Dental Lab, LLC · Aligner, Sequential120 reports
- Candid Aligner FA-0001Candid Care CO. · Aligner, Sequential54 reports
- 3M™ Clarity™ 359-8363m Unitek Corporation · Aligner, sequential1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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