Mouthguard, Prescription
FDA adverse event reports and recall history for mouthguard, prescription (product code MQC), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 580
- Deaths
- 0
- Injuries
- 570
- Malfunctions
- 7
Reports per year
Source: FDA adverse event reports by year received, 2011–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2024-01-03Open, ClassifiedLabeling mix-ups
KeySplint Hard Clear - Indicated for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints, repositioners, and retainers Item No.: 4220011
Keyprint Keysplint Hard Clear 1 kg resin bottles were inadvertently packaged with the wrong Instructions for Use. Keysplint Hard Clear were placed inside a zip lock bag along with KeySplint Soft Instructions for Use (IFU).
- Open, ClassifiedProcess control
KeyPrint Soft- bottle, 32.5 oz (1kg). Resin for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints and repositioners. Model (Ref) #: 4220005
Product label intended for the European community was distributed to the USA market via their US distribution organization
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