Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2622-2023·Announced 2023-09-27

COOLIEF RF Generator recalls due to F100 and F101 fault complaints

Avanos Medical is recalling 24 COOLIEF RF Generator units that have produced F100 and F101 faults. Units were distributed to 17 U.S. states and Brazil.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: FDA Class II recall with customer complaints of device faults but no reported injuries, hospitalizations, or deaths mentioned in source material. Does not meet criteria for Severe or higher classification.

Plain-English summary

Avanos Medical, Inc. is recalling 24 COOLIEF RF Generator units due to customer complaints of F100 and F101 faults. The COOLIEF RF Generator is an 80-watt radiofrequency device with four independent RF channels and a touch screen interface used in medical lesioning procedures.

The manufacturer has received an increase in complaints regarding these faults. The affected units were distributed to 17 U.S. states: Arizona, California, Georgia, Iowa, Indiana, Kansas, Louisiana, Minnesota, North Carolina, New Mexico, New York, Ohio, Oregon, Texas, Virginia, and Vermont, as well as to Brazil.

Devices with the following serial number codes are affected: STZ22277-006 through STZ22277-029 and STZ22318-001.

The recalled product

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…
Manufacturer: Avanos Medical, Inc.
Category: Medical Device — Radiofrequency Generator
Hazard: device-malfunction
Affected units: 24

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

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

Distribution

Distributed in 16 states:

Same manufacturer · Avanos Medical, Inc.

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Same hazard · device malfunction