Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
TX1 Tissue Removal System disposable handpieces. Product Usage: The TX1 Recalled by American Optisurgical Inc Due to American Optisurgical, Inc. is recalling certain lots of...
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 disposable handpieces. Product Usage: The TX1 Tissue Removal System is indicated 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: 1,436 units
Why Was This Recalled?
American Optisurgical, Inc. is recalling certain lots of TX1 Tissue Removal System disposable handpiece due to inventory being released into distribution without a cleared FDA 510(k) to cover recent product changes. Use of this product may lead to an underperformance of the device.
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