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Health Canada Medical devices

EdgeOne Fire (Sterile)

Issued November 28, 2024
Issue
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
Hazard description
Sterility
Product
Product name
EdgeOne Fire (Sterile)
Reference
ID
RA-76601