Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Ondamed Biofeedback Device Recalled by Ondamed Inc Due to The firm was marketing the Ondamed System in...
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 Ondamed Inc directly.
Affected Products
Ondamed Biofeedback Device, Model No. 001-00-0101 The product is a battery powered biofeedback device that is indicated for relaxation training and muscle re-education and prescription use.
Quantity: 585
Why Was This Recalled?
The firm was marketing the Ondamed System in the US without marketing clearance. As a corrective action, the firm revised its device design to comply with regulations. The firm has notified customers that an upgrade for the device is now available, which includes the addition of direct readout and audio signals for heart rate, and visual patient readout of blood oxygen content SpO2.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Ondamed Inc
Ondamed Inc 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