Microline Renew Fenestrated Control Tip Grasper, Single Patient Use, Product Number: 3222 The ReNew Fenestrated Grasper Forceps Tips are intended to cut, grasp, and dissect various abdominal tissue for use in endoscopic, including laproscopic surgical procedures where instruments are introduced onto the body through a cannula.

Recall Insight

This FDA Devices action (record #Z-1635-2014) was formally reported on May 28, 2014, with the manufacturer initiating the action on April 14, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Microline Surgical is listed as the recalling firm, operating out of Beverly, MA. Federal records indicate 540 units units are affected.

The documented reason for this recall is: Grasper jaw may break when force is applied to the jaw Distribution data in the federal record shows the product reached: Worldwide Distribution - US including the states of TX, IL, TN and NY, and the country of Chile.. 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 and NHTSA 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.