Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Aquas PowerFlow Tube Set - Product Usage: The device delivers Recalled by Genicon, Inc. Due to The product design incorporating a motor driven impeller...
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 Genicon, Inc. directly.
Affected Products
Aquas PowerFlow Tube Set - Product Usage: The device delivers sterile irrigation fluids to surgical sites during laparoscopic procedures and to evacuate blood, tissue debris, and smoke from the surgical site
Quantity: 10808 units
Why Was This Recalled?
The product design incorporating a motor driven impeller pump powered by one 9V alkaline battery inside the hand-piece did not receive proper premarket clearance from US FDA and lacks a 510(k).
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Genicon, Inc.
Genicon, Inc. has 18 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report