Ondamed Biofeedback Device Recalled for Lack of Marketing Clearance
Ondamed Inc is recalling 585 Ondamed Biofeedback Devices because they were marketed in the US without FDA clearance. Customers are advised to contact the firm for an available upgrade.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a moderate risk. The source text does not report any illnesses, injuries, or deaths, and the primary issue is regulatory non-compliance (lack of clearance) rather than a direct physical hazard like fire or shock.
Plain-English summary
Ondamed Inc is recalling 585 units of the Ondamed Biofeedback Device, Model No. 001-00-0101. The device is a battery-powered unit indicated for relaxation training and muscle re-education for prescription use. The recall was initiated because the firm was marketing the device in the United States without the required marketing clearance from the FDA.
The affected units were distributed nationwide in the US, as well as to Canada and Taiwan. The recall covers specific lot codes, including M011007, M011012, and numerous other codes listed in the official notice.
As a corrective action, the firm has revised the device design to comply with regulations. Customers have been notified that an upgrade is now available for the device. This upgrade includes the addition of direct readout and audio signals for heart rate, as well as a visual patient readout of blood oxygen content (SpO2).
The recalled product
- Product
- 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.
- Manufacturer
- Ondamed Inc
- Affected units
- 585
Distribution
Distributed nationwide across the United States.
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