Integra® Jarit® 450110RIRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10381780192701), received between Mar 6, 2026 and Mar 6, 2026 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (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

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 6, 2026Break

  A FACILITY REPORTED THE PRODUCT INSERTS FOR MOUTH GAG (450110RI) WAS TORN, DETACHED, AND WAS FROM THE ELASTIC. IT WAS REPORTED THAT THE SURGEON COMPLETED THE PROCEDURE. UPON REMOVING THE MOUTH GAG, THEY NOTICED THAT ONE OF THE PINS CONNECTING THE ELASTIC TO THE MOUTH GAG HAD TORN/DETACHED FROM THE ELASTIC AND WAS MISSING. THEIR TEAM CONDUCTED A SEARCH IN THE OPERATING ROOM AND INSIDE THE PATIENT¿S MOUTH, BUT THE MISSING PART WAS NOT FOUND. THE PHYSICIAN ALSO EXAMINED THE PATIENT¿S ORAL CAVITY AND DID NOT FIND THE MISSING PIN. ACCORDING TO ONE OF THE TEAMMATES, IT WAS IMPOSSIBLE FOR THE DETACHED PART TO HAVE PASSED THROUGH THE SUCTION. THE PATIENT WAS DISCHARGED HOME FEELING WELL AND WITH NO COMPLAINTS. THERE WAS NO DELAY, INJURY, OR DEATH REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 24531202 ↗