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All product recalls associated with Olympus Corporation of the Americas.
Total Recalls
144
Past Year
29
Class I (Serious)
0
Most Recent
Oct 2025
Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.
The Single Use Distal Cover MAJ-2315 may cause mucosal injury and/or become detached from the endoscope during use. Consequences of a detached cover could include the risk of aspiration, inhalation, or obstruction that will require urgent removal, and/or burns from an uncovered distal end.
Product non-conformance pertaining to the angle of the needle does not meet manufacturing specifications and remained unbent, resulting to slight resistance experienced during needle advancement and retraction.
Product non-conformance pertaining to the angle of the needle does not meet manufacturing specifications and remained unbent, resulting to slight resistance experienced during needle advancement and retraction.