The Recall Desk
ModerateFDA (Devices)·Z-0496-2022·Announced 2022-01-19

Electri-Cool II Portable Cold Therapy Unit Recalled for Operating Instruction Labeling Update

Gentherm Medical is recalling 484 Electri-Cool II cold therapy units (Model 767) distributed worldwide to provide updated labeling with revised operating instructions for Cold Therapy pads.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II medical device recall limited to a labeling and instruction update with no reported injuries or illnesses. The recall addresses the need to clarify operating instructions, consistent with minor labeling errors or voluntary precautionary recalls.

Plain-English summary

Gentherm Medical, LLC has initiated a recall of 484 Electri-Cool II Portable Cold Therapy Units, Model Number 767 (Part Number 86193), to provide updated labeling with revised instructions for operating the device with Cold Therapy pads.

The recall affects units with serial numbers 164-76703084 through 213-76703694. These units were distributed worldwide, including the United States and the countries of Canada, Chile, Hong Kong, Korea, and the United Arab Emirates.

Owners of affected units should review the updated labeling and follow the revised operating instructions for proper use of the device with Cold Therapy pads. Consumers with questions about the recall should contact Gentherm Medical, LLC.

The recalled product

Product
Electri-Cool II Portable Cold Therapy Unit, Model Number 767, Part Number 86193
Manufacturer
Gentherm Medical, LLC
Category
Medical Device — Cold Therapy Equipment
Hazard
  • labeling-inadequacy
  • operating-instruction-clarification

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

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

Distribution

Distributed nationwide across the United States.

Related recalls

Same category