Reported Sep 27, 2023 · Completed
COOLIEF RF Generator is an 80-watt Radio-Frequency (RF) Generator with four independent RF channels, allowing all RF…
Avanos Medical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Avanos Medical, Inc. · 5405 Windward Pkwy · Alpharetta, GA · 30004-3894
Is this the product you have?
- 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.
- Lot codes and dates
STZ22277-006STZ22277-007STZ22277-008STZ22277-009STZ22277-010STZ22277-011STZ22277-012STZ22277-013STZ22277-014STZ22277-015STZ22277-016STZ22277-017STZ22277-018STZ22277-019STZ22277-020STZ22277-021STZ22277-022STZ22277-023STZ22277-024STZ22277-025STZ22277-026STZ22277-027STZ22277-028STZ22277-029STZ22318-001
- Amount recalled
- 24 units
Where it was sold
Why it was recalled
Avanos has received an increase in complaints from customers for COOLIEF RF Generators producing F100 and F101 faults.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Avanos Medical, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.