# FDA recall Z-2622-2023

> **Avanos Medical, Inc.** · Class II · device recall initiated 2023-08-01.

## 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.

## Distribution

US Distribution to states of:  AZ, CA, GA, IA, IN, KS, LA, MN, NC, NM, NY, OH, OR, TX, VA, VT, and OUS International distribution to country of:  BRAZIL

## Key facts

- **Recall number:** Z-2622-2023
- **Recalling firm:** Avanos Medical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Completed
- **Initiation date:** 2023-08-01
- **Report date:** 2023-09-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Alpharetta, GA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2622-2023

## Citation

> AI Analytics. FDA recall Z-2622-2023. Retrieved 2026-07-02 from https://api.ai-analytics.org/recall/Z-2622-2023. Source: US FDA. Licensed CC0.

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