9372HD Digital Capture (ver. 1.1.0 + w/ 9263 endoPortal),

Recall Insight

This FDA Devices action (record #Z-0292-2021) was formally reported on November 4, 2020, with the manufacturer initiating the action on September 22, 2020. It is classified under Moderate severity (Class II), with a current status of Terminated. Pentax of America Inc is listed as the recalling firm, operating out of Montvale, NJ. Federal records indicate 39 total units are affected.

The documented reason for this recall is: There is an intermittent software issue that could affect the systems, in which an exam video for one patient (Patient A) might be copied to another patient (Patient B). This does not occur at the time the user performs… Distribution data in the federal record shows the product reached: US Nationwide and Canada. 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 6 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.