ENDOPLUS; Precision Laparoscopic Instruments; REF 345VA; Description 5 mm Traumatic Grasper S/A, Standard; Non-sterile; Manufactured by Endoplus; 750 Tower Rd., Suite A, Mundelein, IL 60060 USA. Intended for grasping, dissecting, retraction, clamping in conjunction with the laparoscopic during laparoscopic surgery.

Recall Insight

This FDA Devices action (record #Z-2265-2013) was formally reported on October 2, 2013, with the manufacturer initiating the action on July 15, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Endoplus, Inc. is listed as the recalling firm, operating out of Mundelein, IL. Federal records indicate 9 units units are affected.

The documented reason for this recall is: Multiple complaints reporting that the moveable jaw has broken during laparoscopic procedures. Distribution data in the federal record shows the product reached: Distributed in the states of FL, TX, and VA.. 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.