Avanos Medical, Inc. 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Avanos Medical, Inc.
Lot Codes / Batch Numbers
STZ22277-006, STZ22277-007, STZ22277-008, STZ22277-009, STZ22277-010, STZ22277-011, STZ22277-012, STZ22277-013, STZ22277-014, STZ22277-015, STZ22277-016, STZ22277-017, STZ22277-018, STZ22277-019, STZ22277-020, STZ22277-021, STZ22277-022, STZ22277-023, STZ22277-024, STZ22277-025, STZ22277-026, STZ22277-027, STZ22277-028, STZ22277-029, STZ22318-001
Products Sold
STZ22277-006, STZ22277-007, STZ22277-008, STZ22277-009, STZ22277-010, STZ22277-011, STZ22277-012, STZ22277-013, STZ22277-014, STZ22277-015, STZ22277-016, STZ22277-017, STZ22277-018, STZ22277-019, STZ22277-020, STZ22277-021, STZ22277-022, STZ22277-023, STZ22277-024, STZ22277-025, STZ22277-026, STZ22277-027, STZ22277-028, STZ22277-029, STZ22318-001
Avanos Medical, Inc. is recalling COOLIEF RF Generator is an 80-watt Radio-Frequency (RF) Generator with four independent RF channels, due to Avanos has received an increase in complaints from customers for COOLIEF RF Generators producing F100 and F101 faults.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Avanos has received an increase in complaints from customers for COOLIEF RF Generators producing F100 and F101 faults.
Recommended Action
Per FDA guidance
AVANOS issued an "URGENT MEDICAL DEVICE RECALL" notice to its consignees on 08/01/2023 via email. The notice explained the reason for the recall, the potential hazard, and requested the following actions: Identify and return the device in accordance with the instructions provided in the customer response form. Distributors were directed to notify their customers. Discontinue use of the COOLIEF* RF Generators identified below. Complete and return the attached CUSTOMER RESPONSE FORM to FieldActionCare@avanos.com Return the affected CRG(s) using the instructions provided in the attached CUSTOMER RESPONSE FORM. Our Customer Service team will work with you to provide a replacement COOLIEF* RF Generator. Avanos's goal is to minimize disruption of your facility while prioritizing the safety of your patients. If you have any questions, call 470-448-5591.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, CA, GA, IN, IA, KS, LA, MN, NM, NY, NC, OH, OR, TX, VT, VA
Page updated: Jan 10, 2026