CLASS II Device recall · Reported 27 Sep 2023 · FDA Enforcement Report

Coolief RF Generator is an 80-watt Radio-Frequency recalled

Avanos Medical is recalling Coolief RF Generator is an 80-watt Radio-Frequency (RF) Generator with four independent, distributed nationwide in the US. The recall was initiated on 1 Aug 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSTZ22277-006, 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

Quantity recalled24 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2622-2023
FDA event ID: 92852
Recalling firm: Avanos Medical, Alpharetta, GA
Classification: Class II
Status: Completed
Recall initiated: 1 Aug 2023
FDA classified: 21 Sep 2023
Reported: 27 Sep 2023
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

1 Aug 2023	Recall initiated by company
21 Sep 2023	Classified by FDA	+51 days
27 Sep 2023	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Avanos has received an increase in complaints from customers for COOLIEF RF Generators producing F100 and F101 faults.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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.

Where it was distributed

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

Nationwide Arizona California Georgia Iowa Indiana Kansas Louisiana Minnesota North Carolina New Mexico New York Ohio Oregon Texas Virginia Vermont

Questions about this recall

Is Coolief RF Generator is an 80-watt Radio-Frequency (RF) Generator with four independent recalled?

Yes. Avanos Medical recalled Coolief RF Generator is an 80-watt Radio-Frequency (RF) Generator with four independent on 1 Aug 2023. The recall is Class II and its status is Completed. Recall number Z-2622-2023.

Why was it recalled?

Avanos has received an increase in complaints from customers for COOLIEF RF Generators producing F100 and F101 faults.

Which lots are affected?

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

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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