Ondamed Biofeedback Device — Class II medical device recall Z-1782-2018
Terminated recall by Ondamed Inc, reported 2018-05-16, distributed nationwide. The firm was marketing the Ondamed System in the US without marketing clearance. As a corrective action, the f
| Recall number | Z-1782-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ondamed Inc, New Windsor, NY, United States |
| Recall initiated | 2017-07-07 |
| Classified | 2018-05-10 |
| Reported by FDA | 2018-05-16 |
| Terminated | 2020-04-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, TW |
| Quantity | 585 |
| Model numbers | 001-00-0101 |
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.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1782-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.