Product Wiki · Recalls · Health Canada — Medical Devices

Single Use Distal Cover — recall 73600

Health Canada — Medical Devices · Canada · 2023-05-05 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
73600
Date of alert
2023-05-05
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Orthopaedics
Product type
Medical devices
Reported risk: 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
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/single-use-distal-cover

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