Gentherm Medical, LLC: Medical Device Recall in 2022 - (Recall #: Z-0496-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

Electri-Cool II Portable Cold Therapy Unit, Model Number 767, Part Number 86193

Product Classification:

Class II

Date Initiated: November 22, 2021

Date Posted: January 19, 2022

Recall Number: Z-0496-2022

Event ID: 89193

Reason for Recall:

This recall has been initiated to provide a labeling update with revised instruction how to operate the unit with Cold Therapy pads.

Status: Terminated

Product Quantity: 484 devices

Code Information:

UDI- 10613031861938; Affected Serial Numbers are: (164-76703084 Through 213-76703694)

Distribution Pattern:

Worldwide distribution - US Nationwide and the countries of Canada, Chile, Hong Kong, Korea, UAE.

Voluntary or Mandated:

Voluntary: Firm initiated