Justright Surgical, JustRight 5mm Reload, REFJR-REL25-2.0, Sterile, EO, Rx Only It is a replacement cartridge used when more than one firing is required during a surgery.

Recall Insight

This FDA Devices action (record #Z-2691-2014) was formally reported on October 1, 2014, with the manufacturer initiating the action on August 27, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Justright Surgical, LLC is listed as the recalling firm, operating out of Boulder, CO. Federal records indicate 3 cases containing 36 units units are affected.

The documented reason for this recall is: JustRight Surgical is recalling specific lots of JustRight 5mm Stapler and Reload products because they may deliver poor distal staple formation, past the end of the knife cut. Distribution data in the federal record shows the product reached: Distributed in the states of Colorado, California and New York.. 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.