Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
American Optisurgical's TX1 Tissue Removal System Console. The console is Recalled by American Optisurgical Inc Due to The recall has been initiated due to an...
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
American Optisurgical's TX1 Tissue Removal System Console. The console is a software unit that is indicated for use in surgical procedures.
Quantity: 194 units
Why Was This Recalled?
The recall has been initiated due to an overheating protection voltage suppressor on the redundant safety protection circuit board. Secondary to the recall, American Optisurgical, Inc. will be making a correction to add spacers between the valve and cassette to correct a small irrigation leak that can occur after the priming cycle. Use of this product may cause the device to lose power and stop wo
Where Was This Sold?
Worldwide distribution, US, including the states of United States: Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington Wisconsin, West Virginia and the countries of Singapore and the Philippines.
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