OBRClass U
Mouthguard, Over-The-Counter
FDA adverse event reports and recall history for mouthguard, over-the-counter (product code OBR), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 1,005
- Deaths
- 0
- Injuries
- 127
- Malfunctions
- 865
Reports per year
412
813
77614
3115
1616
2417
2318
2919
1520
1021
622
523
1824
1325
1626
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
No recalls listed in the FDA device recall database for this entry.
Monitor mouthguard, over-the-counter automatically
DeviceWatch watches FDA adverse events and recalls for the products you care about, summarizes clinical narratives with AI and alerts you when a safety signal emerges.