STRADIS HEALTHCARE, Surg, Item No.40551TMS. oral surgery tray

Recall Insight

This FDA Devices action (record #Z-0487-2023) was formally reported on December 21, 2022, with the manufacturer initiating the action on November 2, 2022. It is classified under Moderate severity (Class II), with a current status of Ongoing. Stradis Medical, LLC dba Stradis Healthcare is listed as the recalling firm, operating out of Peachtree Corners, GA. Federal records indicate 6 units units are affected.

The documented reason for this recall is: Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit. Distribution data in the federal record shows the product reached: US nationwide distribution, 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 4 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.