Synergetics 25 gauge Soft Tip Cannula, packaged in 6 units per box. Catalog number: 30.08.25. Single-use 25 gauge cannula used in vitreoretinal surgery.

Recall Insight

This FDA Devices action (record #Z-0051-2014) was formally reported on October 30, 2013, with the manufacturer initiating the action on July 30, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Synergetics Inc is listed as the recalling firm, operating out of O Fallon, MO. Federal records indicate 48/6-cannula boxes units are affected.

The documented reason for this recall is: One lot of 25 gauge Soft-Tip Disposable Cannulas are co-mingled with 23 gauge cannulas; the product is labeled as 25 gauge cannulas. Distribution data in the federal record shows the product reached: Nationwide Distribution-USA including the states of MO, CO, KY, TN, NC, PA, IL CA, NY, IN, MI, LA, NJ and OH.. 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 13 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.