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Health Canada Medical devices

Ensemble Lap Chole

Issued August 14, 2025
Issue
Medline Industries, LP, is issuing a recall for a pack that contains a ligating clip. This action is being taken because Medline substituted its previous licensed ligating clip with a new version that has not gone through the Health Canada regulatory review (i.e. not licensed). The substitute clip is approved and licensed for use in the united states but has not been licensed for use in Canada. Recall start date: July 23, 2025
Hazard description
Device compatibility
Product
Product name
Ensemble Lap Chole
Reference
ID
RA-77909