Endo Access XGATERecalls & reported problems
Tulsa Dental Products LLC · Endo Access -X Gates · Class 1
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI D716XGATE1), received between Nov 20, 2024 and Nov 20, 2024 — classified as 1 malfunction.
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.
Reports received per month
Most reported problems
Device problems
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 20, 2024Break; Break
C/N: 411578-1, XGATE, LOT: 1871660, 2 PACKS. CUSTOMER HAS BROKEN APPROXIMATELY 2 PACKS OF XGATES DURING USE. NO PATIENT INJURY. THEY DID NOT SAVE THE BROKEN INSTRUMENTS. REPLACING WITH 2 PACKS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20734733 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.