PCF-H190L, EVIS EXERA III COLONOVIDEOSCOPE

Recall Insight

This FDA Devices action (record #Z-0419-2024) was formally reported on December 6, 2023, with the manufacturer initiating the action on October 16, 2023. It is classified under Moderate severity (Class II), with a current status of Ongoing. Aizu Olympus Co., Ltd. is listed as the recalling firm, operating out of Aizuwakamatsu. Federal records indicate 24 incorrectly repaired units units are affected.

The documented reason for this recall is: Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in loss of image, decreased suction, or im… Distribution data in the federal record shows the product reached: Domestic distribution to FL, KY, MA, NJ, NY, and PA. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 3 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.