Mega Needle Driver, 8MM assembly of the da Vinci S IS1200 and da Vinci Si, IS2000. Manufactured by Intuitive Surgical, Sunnyvale, CA. EndoWrist Instruments, including scissors, scalpels, forceps, needle drivers and electrocautery are intended for endoscopic manipulation of tissue, including: grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery and suturing. Mega Needle Driver and Large Needle Driver instruments are part of the EndoWrist instrument family

Recall Insight

This FDA Devices action (record #Z-0520-2014) was formally reported on December 25, 2013, with the manufacturer initiating the action on November 15, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Intuitive Surgical, Inc. is listed as the recalling firm, operating out of Sunnyvale, CA. Federal records indicate 15, 236 UPDATED 12/19/13 to 11,235 units are affected, placing this recall in the million-unit bracket that typically triggers nationwide consumer alerts and retailer sweeps.

The documented reason for this recall is: Firm has become aware of the potential for detachment of the jaw insert for Large Needle Drivers and Mega Needle Drivers. Distribution data in the federal record shows the product reached: Worldwide Distribution - USA (nationwide and Puerto Rico) and Internationally to Finland, Belgium, Netherlands, UK, Czech Republic, Sweden, Germany, Austria, Switzerland, Norway, Denmark, South Korea, France, Ireland, a…. 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.