COOLIEF RF Generator is an 80-watt Radio-Frequency — Class II medical device recall Z-2622-2023
Completed recall by Avanos Medical, Inc., reported 2023-09-27, distributed in AZ, CA, GA, IA, IN, KS, LA, MN…. Avanos has received an increase in complaints from customers for COOLIEF RF Generators producing F100 and F101
| Recall number | Z-2622-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Avanos Medical, Inc., Alpharetta, GA, United States |
| Recall initiated | 2023-08-01 |
| Classified | 2023-09-21 |
| Reported by FDA | 2023-09-27 |
| Distributed | AZ, CA, GA, IA, IN, KS, LA, MN, NC, NM, NY, OH, OR, TX, VA, VT |
| Countries outside the US | BR |
| Quantity | 24 units |
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.
Reason for recall
Avanos has received an increase in complaints from customers for COOLIEF RF Generators producing F100 and F101 faults.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2622-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.