Ondamed Biofeedback Device Model 001-00-0101 Recall: Unapproved Marketing
Ondamed recalls a battery-powered biofeedback device (Model 001-00-0101) sold without FDA marketing clearance. The company has issued an upgrade to improve safety and compliance.
Lower-risk 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.
Contact the company
What happened, in plain English
Ondamed is recalling a specific biofeedback device model that was sold in the U.S. without proper regulatory approval. The company has since updated the device to add safety features like heart rate and blood oxygen monitoring. Read more at govinfonow.com/recall/73455-ondamed-biofeedback-device-model-001-00-0101-recall-unapproved-marketing.
Source Summary by GovInfoNow · govinfonow.com/recall/73455-ondamed-biofeedback-device-model-001-00-0101-recall-unapproved-marketing · Updated September 21, 2026 · FDA enforcement record: FDA #Z-1782-2018
Cite this page
“Ondamed Biofeedback Device Model 001-00-0101 Recall: Unapproved Marketing.” GovInfoNow, updated September 21, 2026. https://govinfonow.com/recall/73455-ondamed-biofeedback-device-model-001-00-0101-recall-unapproved-marketing. Based on FDA recall #Z-1782-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1782-2018%22&limit=1).
Why it’s dangerous
The device was sold without FDA marketing clearance, meaning it did not meet safety and performance standards. However, the company has since released an upgrade to add critical safety features like heart rate and blood oxygen monitoring.
Who’s affected
Users of the Ondamed Biofeedback Device Model 001-00-0101, particularly those with prescription use for relaxation training or muscle re-education. The risk is low as the device was not marketed with clearance.
How to tell if you have this one
Check for the model number 001-00-0101 on the device. The product was sold in the U.S. with specific serial numbers listed in the recall notice.
- Brand
Ondamed- Category
Medical device
What to do — step by step
Check for Model Update
The company has issued an upgrade for the device that includes direct readout and audio signals for heart rate, and visual patient readout of blood oxygen content SpO2.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide Distribution - USA (nationwide) and to the counties of : Canada and Taiwan.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 2.8 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Do I need to stop using this device?
No, the company has provided an upgrade to improve safety. You can continue using the device after applying the update.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1782-2018 (July 7, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1782-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 21, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.