Recall Monitor
Health Products

MOLLI 2 Systems

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - General hospital and personal use, Health products - Medical devices - General and plastic surgery
Product: MOLLI 2 Systems
Issue: Medical devices - Labelling and packaging
What to do: Contact the manufacturer if you require additional information.
Audience: General public, Healthcare, Industry
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalogue number
MOLLI OncoPenVariousMP2015A
MOLLI 2 TabletVariousMT2001
MOLLI 2 WandVariousMP2001
MOLLI Introducer And MOLLI MarkerVariousMS-00009
MOLLI Introducer And MOLLI MarkerVariousMM1000

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.

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