CanadaMOLLI 2 Systems including MOLLI OncoPen (MP2015A), MOLLI 2 Tablet (MT2001), MOLLI 2 Wand (MP2001), and MOLLI Introducer and MOLLI Marker (MS-00009, MM1000) distributed by Stryker Endoscopy are affected. Stryker updated the Instructions for Use after two FDA medical device reports of patient injuries from MOLLI Marker dislodgement or dislocation caused by magnetic attraction from magnetized surgical tools; contact the manufacturer for additional information.
What's being recalled
Companies: Stryker Endoscopy, A Div. Of Stryker Corp. Dba Stryker Endoscopy, 5900 Optical Court, San Jose, California, United States, 95138.
How to identify it
Affected products: MOLLI OncoPen; Lot or serial number: Various; Model or catalogue number: MP2015A
Affected products: MOLLI 2 Tablet; Lot or serial number: Various; Model or catalogue number: MT2001
Affected products: MOLLI 2 Wand; Lot or serial number: Various; Model or catalogue number: MP2001
Affected products: MOLLI Introducer And MOLLI Marker; Lot or serial number: Various; Model or catalogue number: MS-00009
Affected products: MOLLI Introducer And MOLLI Marker; Lot or serial number: Various; Model or catalogue number: MM1000
The hazard
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
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)