COOLIEF RF Generator is an 80-watt Radio-Frequency (RF)… recallZ-2622-2023 · Avanos Medical, Inc. · initiated Aug 1, 2023
Class II Completed All recalls posted in September 2023
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Avanos Medical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Avanos has received an increase in complaints from customers for COOLIEF RF Generators producing F100 and F101 faults.
FDA root cause category: Process change control
What the company is doing
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.
Recall details
- Recall number
- Z-2622-2023
- Recall class
- Class II
- Status
- Completed
- Initiated by the company
- Aug 1, 2023
- Posted by the FDA
- Sep 21, 2023
- Recalling firm
- Avanos Medical, Inc.
- Quantity
- 24 units
- Product code
- GXD
- FDA submissions
- K192491
- 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 description
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.
Code information (models, lots, serial numbers)
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
Other devices under the same FDA submission
2 devices cleared under K192491 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- COOLIEF* Cooled RF Advanced Generator CRG-ADVANCEDAvanos Medical, Inc. · Generator, lesion, radiofrequency6 reports
- COOLIEF* Cooled RF Advanced-R Generator CRG-ADVANCED-RAvanos Medical, Inc. · Generator, lesion, radiofrequency1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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