Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported May 16, 2018
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.
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 ha…
Ondamed Inc recalled Ondamed Biofeedback Device, Model No. 001-00-0101 The product is a battery powered bio… - a moderate-severity action.
Ondamed Biofeedback Device, Model No. 001-00-0101 The product is a battery powered bio… was recalled by Ondamed Inc in May 16, 2018. Reason: The firm was marketing the Ondamed System in the US without marketing clearance. As a corrective action, the …. Check the official notice for the remedy. Verify recall #Z-1782-2018 with the FDA Devices before acting.
The recall
Ondamed Inc issued this moderate-severity FDA Devices recall-The firm was marketing the Ondamed System in the US without marketing clearance. As a corrective action, the ….
- Moderate
- severity level
- 585 units
- affected scope
- Class II
- classification
- May 16, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1782-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1782-2018) was formally reported on May 16, 2018, with the manufacturer initiating the action on July 7, 2017. It is classified under Moderate severity (Class II), with a current status of Terminated. Ondamed Inc is listed as the recalling firm, operating out of New Windsor, NY. Federal records list the affected scope as 585.
The documented reason for this recall is: 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… Distribution data in the federal record shows the product reached: Worldwide Distribution - USA (nationwide) and to the counties of : Canada and Taiwan.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,861 medical devices recalls on record
Of 88,001 recalls with an agency hazard classification, 19,020 are high severity, 64,468 moderate, and 4,513 low. A further 16,157 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
585
Related Recalls
6
6 from same agency
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1782-2018 |
| Date reported | May 16, 2018 |
| Date initiated | July 7, 2017 |
| Recalling firm | Ondamed Inc |
| Firm location | New Windsor, NY |
| Affected scope | 585 |
| Distribution | Worldwide Distribution - USA (nationwide) and to the counties of : Canada and Taiwan. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1782-2018) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Ondamed Inc. Units affected: 585.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 16, 2018. Severity: Moderate. Recall number: Z-1782-2018.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - USA (nationwide) and to the counties of : Canada and Taiwan..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1782-2018) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nationwide recalls with similar severity or category timing
Two federal-filing-derived peer sets for this notice, both outside the same recalling firm and filing state so the neighborhoods are not firm or geographic containment.
Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
Showing 5 of 40909 other recalls in this category.
FDA Devices Moderate
FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature and into the chambers of the heart, Mate…
Boston Scientific Corporation · 2026-07-29
FDA Devices Moderate
FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Cathe…
Boston Scientific Corporation · 2026-07-29
FDA Devices Moderate
Halyard STANDARD LINE INSERTION PACK. Model/Catalog Number: PVHM234-01. Convenience kit.
AVID Medical, Inc. · 2026-07-29
FDA Devices Moderate
Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT
Penumbra, Inc. · 2026-07-29
FDA Devices Moderate
SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System
Alphatec Spine, Inc. · 2026-07-29
Compare this recall with FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access… →
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported May 16, 2018. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.