Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
OsteoMed OsteoPower Power Console: -OsteoMed OsteoPower Power Console 2 REF Recalled by Osteomed, LLC Due to Due to consoles not in compliance with the...
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 Osteomed, LLC directly.
Affected Products
OsteoMed OsteoPower Power Console: -OsteoMed OsteoPower Power Console 2 REF 450-0021-00 -OsteoMed D-Power Control Console 2 REF 450-0021-01 -Power Control Console 2 REF ECOS-450-0021-00 -OsteoMed OsteoPower Power Console 2i REF 450-0005-00 -OsteoMed D-Power Control Console 2i REF 450-0005-01 -Power Control Console 2i REF ECOS-450-0005-00 OsteoMed Footswitches: -OsteoMed BMF Footswitch REF 450-0390 -D-Bi-Directional Master Footswitch REF 450-0380 -D-Uni-Directional Footswitch II REF 450-0350 -D-Bi-Directional Footswitch II REF 450-0360 -D-Uni-Directional Master Footswitch REF 450-0370
Quantity: 533 consoles and 586 footswitches
Why Was This Recalled?
Due to consoles not in compliance with the latest electrical safety standards IEC 60601 and as a result shocked a patient.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Osteomed, LLC
Osteomed, LLC has 15 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report