Official recall record
MOLLI 2 Systems
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2026-01-23
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
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
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.
Verify at the source:
Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
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