PRE2001: Prevena Incision Management Customizable System Box Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.

Recall Insight

This FDA Devices action (record #Z-1139-2014) was formally reported on March 12, 2014, with the manufacturer initiating the action on January 30, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. KCI USA, INC. is listed as the recalling firm, operating out of San Antonio, TX. Federal records indicate 20,850 units total units are affected.

The documented reason for this recall is: Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing Distribution data in the federal record shows the product reached: USA Nationwide Distribution. 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 12 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.