Ondamed Biofeedback Device
Medical device recall Z-1782-2018. Published in FDA’s Enforcement Report on May 16, 2018.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on May 16, 2018. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 585 how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“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.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are 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.
585, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
M011007 M011012 M011013 M011021 M011022 M011026 M011027 M011028 M030202 M030204 M030205 M030211 M030211b (Dup) M030212 M030213 M030217 M030218 M030219 M030222 M030225 M030226 M030227 M030228 M030229 M030230 M030231 M030232 M030238 M030242…
Every code shown here, 1,995 characters
M011007 M011012 M011013 M011021 M011022 M011026 M011027 M011028 M030202 M030204 M030205 M030211 M030211b (Dup) M030212 M030213 M030217 M030218 M030219 M030222 M030225 M030226 M030227 M030228 M030229 M030230 M030231 M030232 M030238 M030242 M030244 M030246 M030247 M030248 M030249 M040201 M040202 M040203 M040204 M040207 M040208 M040209 M040210 M040218a M040218b M040218c M040219 M040220 M040221 M040221a M040222 M040223 M040224 M040225 M040226 M040237 M040238 M040242 M040243 M040245 M040246 M040248 M040248a M040253 M040254 M040255 M040260 M050400 M050413 M050414 M050415 M050416 M050419 M050419a M050420 M050421 M050423 M050425 M050426 M050428 M050430 M050431 M050431 M050432a M050436 M050438 M050439 M050440 M050447 M050447a M050453 M050456 M050457 M050458 M051101 M051102 M051103 M051105 M051110 M051111 M051112 M051113 M051114 M051115 M051116a M051120 M051121 M051124 M051125 M051133 M051134 M051135 M051136 M051138 M051142 M051143 M051146 M051147 M051154 M051155 M060701 M060702 M060703 M060704 M060706 M060707 M060713 M060714 M060715 M060716 M060717 M060718 M060719 M060720 M060727 M060728 M060729 M060730 M060731 M060732 M060733 M060734 M060739 M060740 M060741 M060742 M060744 M060747 M060748 M060748a M060749 M060750 M060751 M060752 M060753 M07003 M07004 M07005 M07006 M07008 M07009 M07011 M07012 M07013 M07014 M07015 M07016 M07017 M07018 M07021 M07026 M07027 M07028 M07029 M07030 M07031 M07032 M07033 M07040 M07040a M07041 M07041 M07042 M07043 M07046 M07047 M07048 M07049 M07051 M07053 M07059a M07060 M07062 M07065 M07066 M07067 M07068 M07069 M07070 M07071 M07072 M07075 M07076 M07078 M07079 M07080 M07082 M07083 M07084 M07085 M07086 M07088 M07090 M07091 M07092 M07093 M07094 M07095 M07096 M07097 M07123 M07128 M07132 M08002 M08003 M08003a M08004 M08007 M08008 M08010 M08011 M08012 M08013 M08014 M08015 M08018 M08019 M08020 M08022 M08023 M08024 M08026 M08027 M08029 M08030 M08037 M08038 M08039 M08040 M08041 M08042 M08043 M08044 M08048 M08049 M08050 M08051 M08051a M08052 M08053 M08054…
FDA’s list runs to 3,842 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide Distribution - USA (nationwide) and to the counties of : Canada and Taiwan.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Jul 7, 2017.
- FDA classified it on May 10, 2018.
- FDA’s Enforcement Report published it on May 16, 2018.
- FDA terminated it on Apr 24, 2020.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Ondamed Inc, of New Windsor, NY.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 3,842 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.