Z-2622-2023Class II

COOLIEF RF Generator is an 80-watt Radio-Frequency (RF) Generator with four independent RF channels, allowing...

Name: Z-2622-2023 COOLIEF RF Generator is an 80-watt Radio-Frequency (RF) Generator with four independent RF channels, allowing...
Creator: Avanos Medical, Inc.
Published: 2023-08-01
License: https://open.fda.gov/license/

Halyard Health / initiated 2023-08-01 / Completed

FDA source

Avanos Medical, Inc. began a recall of 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... on 2023-08-01. FDA classified it as Class II and gives the reason as "Avanos has received an increase in complaints from customers for COOLIEF RF Generators producing F100 and F101 faults". As of 2026-09-10, the recall status on record is Completed.

Recall record

Recall number: Z-2622-2023
Classification: Class II
Status: Completed
Initiated: 2023-08-01
Posted: 2023-09-21
Recalling firm: Halyard Health
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.
Product code: GXD Generator, Lesion, Radiofrequency
Reason for recall: Avanos has received an increase in complaints from customers for COOLIEF RF Generators producing F100 and F101 faults.
FDA root cause: Process change control
Action: AVANOS issued an "URGENT MEDICAL DEVICE RECALL" notice to its consignees on 08/01/2023 via email. The notice explained the reason for the recall, the potential hazard, and requested the following actions: Identify and return the device in accordance with the instructions provided in the customer response form. Distributors were directed to notify their customers. Discontinue use of the COOLIEF* RF Generators identified below. Complete and return the attached CUSTOMER RESPONSE FORM to [email protected] Return the affected CRG(s) using the instructions provided in the attached CUSTOMER RESPONSE FORM. Our Customer Service team will work with you to provide a replacement COOLIEF* RF Generator. Avanos's goal is to minimize disruption of your facility while prioritizing the safety of your patients. If you have any questions, call 470-448-5591.
Quantity in commerce: 24 units
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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2622-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2622-2023	Class II	Completed	Voluntary: Firm initiated	2023-09-27	2023-09-21

Product code GXD

K192491Class IICoolief Radiofrequency Generator (CRG) SystemAvanos Medical, Inc. / cleared 2020-02-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)