TX1 Tissue Removal System. TX1 Procedure Pack P/N 554-1003-001 (outer box), TX1 MicroTip P/N 554-1002-001 (inner tray). For use with the TX System Console as an ultrasonic surgical aspirator of soft tissue.

Recall Insight

This FDA Devices action (record #Z-1552-2014) was formally reported on May 14, 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. Tenex Health Inc is listed as the recalling firm, operating out of Lake Forest, CA. Federal records indicate 9,927 units units are affected.

The documented reason for this recall is: The sterile barrier in the packaging may be compromised due to cracks in the thermoform tray that may occur during transport of the product in extreme cold weather conditions, in conjunction with mechanical impact. Distribution data in the federal record shows the product reached: Worldwide Distribution - USA (Nationwide) and Internationally to Panama and Singapore.. 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.