Integra Selector Kit Sterile single use device A bi-lumen, sterile single use accessory used for the Selector Integra Ultrasonic Surgical Aspirator system. One of the tubing lumen transmits irrigation fluid from the console to the handpiece of the system, and the other tubing lumen transmits aspirated fluid and tissue back to the system console. The aspirator is intended to be used to facilitate the removal of cellular and other unwanted soft tissue. The system provides selective tissue disinte

Recall Insight

This FDA Devices action (record #Z-0491-2015) was formally reported on December 10, 2014, with the manufacturer initiating the action on September 29, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Integra LifeSciences Corp. is listed as the recalling firm, operating out of Plainsboro, NJ. Federal records indicate 6,358 tubing kits units are affected.

The documented reason for this recall is: Some specific lots of Selector Tubing may potentially leak irrigation fluid during use if not placed on the Selector handpiece in a specific manner. Distribution data in the federal record shows the product reached: Worldwide Distribution - USA (nationwide) and Internationally to Algeria, Australia, Bulgaria, Canada, Germany, Great Britain, Greece, Hungary, Indonesia, Israel, Italy, Japan, Mexico, Portugal, Spain, Sweden, Thailand,…. 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.