Avanos Medical, Inc.: Medical Device Recall in 2023 - (Recall #: Z-2622-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: August 1, 2023

Date Posted: September 27, 2023

Recall Number: Z-2622-2023

Event ID: 92852

Reason for Recall:

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

Status: Completed

Product Quantity: 24 units

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated