Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
COOLIEF RF Generator is an 80-watt Radio-Frequency (RF) Generator with Recalled by Avanos Medical, Inc. Due to Avanos has received an increase in complaints from...
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 Avanos Medical, Inc. directly.
Affected Products
COOLIEF RF Generator is an 80-watt Radio-Frequency (RF) Generator with four independent RF channels, allowing all RF channels to be activated individually or altogether. The system is controlled via a touch screen interface display that includes user controls, alarm messages, and on-screen selection of lesioning modalities.
Quantity: 24 units
Why Was This Recalled?
Avanos has received an increase in complaints from customers for COOLIEF RF Generators producing F100 and F101 faults.
Where Was This Sold?
This product was distributed to 16 states: AZ, CA, GA, IN, IA, KS, LA, MN, NM, NY, NC, OH, OR, TX, VT, VA
About Avanos Medical, Inc.
Avanos Medical, Inc. has 37 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report