MOLLI 2 Systems
Last updated
Summary
Product
MOLLI 2 Systems
Issue
Medical devices - Labelling and packaging
What to do
Contact the manufacturer if you require additional information.
Affected products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| MOLLI OncoPen | Various | MP2015A |
| MOLLI 2 Tablet | Various | MT2001 |
| MOLLI 2 Wand | Various | MP2001 |
| MOLLI Introducer And MOLLI Marker | Various | MS-00009 |
| MOLLI Introducer And MOLLI Marker | Various | MM1000 |
Issue
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.
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General hospital and personal use
Health products - Medical devices - General and plastic surgery
Companies
| Stryker Endoscopy, A Div. Of Stryker Corp. Dba Stryker Endoscopy |
| 5900 Optical Court, San Jose, California, United States, 95138 |
Published by
Health Canada
Audience
General public
Healthcare
Industry
Recall class
Type II
Recall date
Identification number
RA-81524
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