Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
TX1 Tissue Removal System Console. Model: TX1 TX1 Tissue Removal Recalled by American Optisurgical Inc Due to Two reasons for recall. 1. Incorrect pressure relief...
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 American Optisurgical Inc directly.
Affected Products
TX1 Tissue Removal System Console. Model: TX1 TX1 Tissue Removal System is an ultrasonic aspirator that emulsifies and removes soft tissue. The TX1 Console provides control over each mode of operation, as well as the user interface via LCD touchscreen and audible tones for confirmation of user selections. Indiciated for use in surgical procedures where fragmentation, emulsification, and aspiration of soft tissue are desirable, including General Surgery, Orthopedic Surgery, Laparoscopic Surgery and Plastic and Reconstructive Surgery.
Quantity: 5units
Why Was This Recalled?
Two reasons for recall. 1. Incorrect pressure relief valve installed inside console, leading to a remote chance of a risk to health. 2. Technical Specifications, under Irrigation, the Operating Pressure value is incorrect.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About American Optisurgical Inc
American Optisurgical Inc has 4 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report