Recall MonitorHealth Products
MicroMyst applicator and extended tip applicators
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - General hospital and personal use
Product: MicroMyst applicator and extended tip applicators
Issue: Medical devices - Sterility
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
Products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Extended Tip Applicator - Single Use Applicator 15 Cm | More than 10 numbers, contact manufacturer. | 205115 |
| MicroMyst Applicator | More than 10 numbers, contact manufacturer. | 205000DS |
| Extended Tip Applicator - Single Use Applicator 8 Cm | More than 10 numbers, contact manufacturer. | 205108 |
Issue
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