Public recall detail

EdgeOne Fire (Sterile)

2024-11-28

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Recall Safety notice
Quick summary

Quick summary: EdgeOne Fire (Sterile). Date: 2024-11-28.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: EdgeOne Fire (Sterile). Date: 2024-11-28.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandUS Endodontics
ProductEdgeOne Fire (Sterile)
IssueMedical devices - Sterility
Recall classType II
IdentificationRA-76601

Affected products

ProductEdgeOne Fire (Sterile)
Lot032924052 032924061
ModelSEOFGP21
Serial number032924052 032924061
DescriptionEdgeOne Fire (Sterile)

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

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare Industry
CategoryHealth products - Medical devices - Dental
CompaniesUS Endodontics 2809 W. Walnut St., Johnson City, Tennessee, United States, 37604
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-76601
Background{}
CompaniesUS Endodontics 2809 W. Walnut St., Johnson City, Tennessee, United States, 37604
AudiencesHealthcare Industry
Source updated2024-11-28

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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