Reported Jan 19, 2022 · Terminated

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

Gentherm Medical, LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Gentherm Medical, LLC · 12011 Mosteller Rd Fl 3 · Blue Ash, OH · 45241-1528

Is this the product you have?

    • Electri-Cool II Portable Cold Therapy Unit
    • Model Number 767
    • Part Number 86193
Lot codes and dates
  • UDI- 10613031861938
  • Affected Serial Numbers are(164-76703084 Through 213-76703694)
Amount recalled
484 devices

Where it was sold

  • Nationwide

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated May 8, 2023 · Data as of Sep 19, 3:33 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.