Product Wiki · Recalls · Health Canada — Medical Devices

MicroMyst applicator and extended tip applicators — recall 77582

Health Canada — Medical Devices · Canada · 2025-06-11 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
77582
Date of alert
2025-06-11
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
General hospital and personal use
Product type
Medical devices
Reported risk: The decision to conduct a recall of the MicroMyst applicator and extended tip applicators was based on internal investigation that demonstrated an incomplete bioburden assessment and an incomplete sterilization location transfer documentation to ensure the effectiveness of the sterilization process. The investigation also identified that the extended tip applicators, exclusively, could potentially contain out-of-specification levels of endotoxin. Recall start date: June 2, 2025
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/micromyst-applicator-and-exten

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.