WECK Visistat 35R Disposable Skin Stapler, Ref 528135, Rx Only, Sterile EO, Visistat is indicated for the external skin closure of lacerations on the outer layer of the dermis for a wide range of general, thoracic, obstetric, gynecological, orthopedic, cardiovascular, urological, and plastic surgical procedures

Recall Insight

This FDA Devices action (record #Z-2108-2017) was formally reported on May 24, 2017, with the manufacturer initiating the action on March 24, 2017. It is classified under Moderate severity (Class II), with a current status of Completed. Teleflex Medical is listed as the recalling firm, operating out of Research Triangle Park, NC. Federal records indicate 3594 eaches units are affected.

The documented reason for this recall is: Some boxes are labeled as containing Visistat Wide devices, when they in fact they contained Visistat Regular device. Distribution data in the federal record shows the product reached: Worldwide Distribution - US including CA, FL, GA, IL, IN, KS, KY, ME, MD, MA, MI, NJ, NY, NC, OH, OR, RI, TX, UT, VA, and Internationally to Australia, Belgium and France. 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 9 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.