Public recall detail

MOLLI 2 Systems

2026-01-23

medium
Recall Safety notice
Quick summary

Quick summary: MOLLI 2 Systems. Date: 2026-01-23.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: MOLLI 2 Systems. Date: 2026-01-23.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandSTRYKER ENDOSCOPY, A DIV. OF STRYKER CORP. DBA STRYKER ENDOSCOPY
ProductMOLLI 2 Systems
IssueMedical devices - Labelling and packaging
Recall classType II
IdentificationRA-81524

Affected products

ProductMOLLI OncoPen
LotVarious
ModelMP2015A
Serial numberVarious
DescriptionMOLLI OncoPen
ProductMOLLI 2 Tablet
LotVarious
ModelMT2001
Serial numberVarious
DescriptionMOLLI 2 Tablet
ProductMOLLI 2 Wand
LotVarious
ModelMP2001
Serial numberVarious
DescriptionMOLLI 2 Wand
ProductMOLLI Introducer And MOLLI Marker
LotVarious
ModelMS-00009
Serial numberVarious
DescriptionMOLLI Introducer And MOLLI Marker
ProductMOLLI Introducer And MOLLI Marker
LotVarious
ModelMM1000
Serial numberVarious
DescriptionMOLLI Introducer And MOLLI Marker

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.

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceGeneral public Healthcare Industry
CategoryHealth products - Medical devices - General hospital and personal use Health products - Medical devices - General and plastic surgery
CompaniesStryker Endoscopy, A Div. Of Stryker Corp. Dba Stryker Endoscopy 5900 Optical Court, San Jose, California, United States, 95138
Recall date2026-01-15
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-81524
Background{}
CompaniesStryker Endoscopy, A Div. Of Stryker Corp. Dba Stryker Endoscopy 5900 Optical Court, San Jose, California, United States, 95138
AudiencesGeneral public Healthcare Industry
Source updated2026-01-23

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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