Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
THERMI250 Radiofrequency System. Intended to provide heating for the purpose Recalled by Bios S.r.l. Due to In some systems, the unit continues to emit...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Bios S.r.l. directly.
Affected Products
THERMI250 Radiofrequency System. Intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions.
Quantity: 167 units
Why Was This Recalled?
In some systems, the unit continues to emit RF energy after the PAUSE button is pressed.
Where Was This Sold?
This product was distributed to 25 states: AZ, AR, CA, FL, GA, ID, IL, KS, LA, MA, MI, MS, MO, NV, NJ, NM, NY, OH, OR, PA, SD, TX, WA, WV, WI
About Bios S.r.l.
Bios S.r.l. has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report