Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
TX1 Tissue Removal System. TX1 Procedure Pack P/N 554-1003-001 (outer box) Recalled by Tenex Health Inc Due to The sterile barrier in the packaging may be...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Tenex Health Inc directly.
Affected Products
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.
Quantity: 9,927 units
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Tenex Health Inc
Tenex Health Inc has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report