Official recall record
MicroMyst applicator and extended tip applicators
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2025-06-11
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
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
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.
Record last checked against the registry on 2026-05-31.