> ## Content Index
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# Alert on Hot/Cold Therapy Devices
- URL: https://www.fdaweb.com/alert-on-hot-cold-therapy-devices/
- Published: 2020-09-09T12:00:00.000Z
- Updated: 2026-09-14T16:28:06.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5147613

An FDA [safety alert](https://www.fda.gov/medical-devices/safety-communications/fda-reminds-users-about-importance-following-instructions-cold-therapy-mode-water-circulating?utm%5Fcampaign=2020-09-09%20CDRH%20Safety%20Comm%20Hot%2FCold%20Therapy&utm%5Fmedium=email&utm%5Fsource=Eloqua) warns patients and health care providers about the risk of injury that may happen to patients if the cold-therapy mode of [water-circulating hot/cold therapy devices](https://www.fda.gov/medical-devices/safety-communications/fda-reminds-users-about-importance-following-instructions-cold-therapy-mode-water-circulating?utm%5Fcampaign=2020-09-09%20CDRH%20Safety%20Comm%20Hot%2FCold%20Therapy&utm%5Fmedium=email&utm%5Fsource=Eloqua#description) is not used correctly. “Patients who use these devices may get injuries from the cold, such as temporary (transient) numbness or discoloration, or frostbite and cell death (necrosis), which may require skin grafts, muscle/skin flap reconstruction, or amputation,” the alert says. The notice is also intended to help remind health care providers and patients about important instructions for use, warnings, and precautions.