MOLLI 2 Systems
In plain language
Stryker has updated the MOLLI 2 system Instructions for Use (IFU) following two medical device reports (MDRs) submitted to the FDA (June 5 2025). These reports involved patient injuries associated with MOLLI Marker dislodgement or dislocation due to magnetic attraction from magnetized surgical tools. The updated IFU now includes an additional warning that using magnetized surgical tools in close proximity to the marker during localization may lead to marker dislodgement.
What to do
- Stop using the product immediately.
- Check model or serial numbers if provided.
- Return, repair, or dispose of it as instructed.
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Affected products
Specific affected products are listed in the official notice.
Why this matters
Type II
Do I have this product?
This recall applies to specific products. Details are listed in the official notice.
Frequently Asked Questions
Why was this product recalled?
Type II
What should consumers do?
Stop using the product immediately. Check model or serial numbers if provided. Return, repair, or dispose of it as instructed.
Where was the product sold?
This product was sold in Canada. For specific retailers or distribution areas, please check the official recall notice linked on this page.
Is there a health risk?
Yes, there may be a health risk. Type II
When was this product recalled?
This product was recalled on January 23, 2026.