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Health Canada Medical devices

Single Use Distal Cover

Issued May 5, 2023
Issue
Olympus has become aware that the single use distal cover MAJ-2315 may cause mucosal injury, become cracked and/or detach from the endoscope during use. Olympus redesigned the distal cover and has observed a decrease in the referenced complaints. Olympus is initiating a medical device recall for distal covers with the original design. Recall start date: April 21, 2023
Hazard description
Performance
Product
Product name
Single Use Distal Cover
Reference
ID
RA-73600