Official recall record
EdgeOne Fire (Sterile)
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2024-11-28
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
The manufacturer US Endodontics, LLC., has recalled certain lots of sterile EdgeOne Fire GlidePath distributed between May 03, 2024 through May 17, 2024. This recall is initiated as during an evaluation of internal validations, it was identified that the devices in question were irradiated above the established max dose. Recall Start Date: November 22, 2024
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
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