Omnicycle Elite
Medical device recall Z-1837-2013. Published in FDA’s Enforcement Report on Aug 7, 2013.
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 Aug 7, 2013. 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
- 1001 units 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?
An anomaly in the firmware that may cause Omnicycle Elite to operate at a speed other than what was previously set when in reverse mode.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Omnicycle Elite; US Importer and Distributor: Accelerated Care Plus, Reno NV. Manufactured by Medica Medizintechnik GmbH, Hochdorf, Germany. The product is indicated for powered exercise equipment intended for medical purposes.
1001 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Model number A000-533: Serial numbers: 1034-000-00-09033104 1034-000-00-09033107 1034-000-00-09033108 1034-000-00-09033119 1034-000-00-09033120 1034-000-00-09033121 1034-000-00-09033122 1034-000-00-09033132 1034-000-01-09073002…
Every code shown here, 1,992 characters
Model number A000-533: Serial numbers: 1034-000-00-09033104 1034-000-00-09033107 1034-000-00-09033108 1034-000-00-09033119 1034-000-00-09033120 1034-000-00-09033121 1034-000-00-09033122 1034-000-00-09033132 1034-000-01-09073002 1034-000-01-09073005 1034-000-01-09073018 1034-000-01-09073021 1034-000-01-09073030 1034-000-01-09073123 1034-000-01-09073129 1034-000-01-09073130 1034-000-01-09073134 1034-000-01-09073136 1034-000-01-09073142 1034-000-01-09073146 1034-000-01-09073147 1034-000-01-09090034 1034-000-01-09101119 1034-000-01-09101126 1034-000-01-09101127 1034-000-01-09102107 1034-000-01-09104132 1034-000-01-09105032 1034-000-01-09105039 1034-000-01-09152114 1034-000-01-09152117 1034-000-01-09152120 1034-000-01-09152131 1034-000-01-09162027 1034-000-01-09162034 1034-000-01-09163094 1034-000-01-09163101 1034-000-01-09164098 1034-000-01-09164101 1034-000-01-09164114 1034-000-01-09171128 1034-000-01-09172011 1034-000-01-09172020 1034-000-01-09172021 1034-000-01-09172026 1034-000-01-09172028 1034-000-01-09172035 1034-000-01-09172041 1034-000-01-09172042 1034-000-01-09172046 1034-000-01-09172049 1034-000-01-09172053 1034-000-01-09172060 1034-000-01-09172064 1034-000-01-09172066 1034-000-01-09172070 1034-000-01-09172074 1034-000-01-09172083 1034-000-01-09201007 1034-000-01-09201105 1034-000-01-09201113 1034-000-01-09201118 1034-000-01-09201124 1034-000-01-09201125 1034-000-01-09201133 1034-000-01-09201135 1034-000-01-09201138 1034-000-01-09201139 1034-000-01-09261004 1034-000-01-09261006 1034-000-01-09261008 1034-000-01-09261009 1034-000-01-09261011 1034-000-01-09261017 1034-000-01-09261019 1034-000-01-09261033 1034-000-01-09261048 1034-000-01-09261060 1034-000-01-09261067 1034-000-01-09261077 1034-000-01-09261081 1034-000-01-09261090 1034-000-01-09261092 1034-000-01-09294043 1034-000-01-09294051 1034-000-01-09294052 1034-000-01-09294057 1034-000-01-09294059 1034-000-01-09294071 1034-000-01-09294072 1034-000-01-09294075 1034-000-01-09294078 1034-000-01-09294079…
FDA’s list runs to 19,710 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.
Nationwide Distribution.
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.
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 Jun 12, 2013.
- FDA classified it on Jul 31, 2013.
- FDA’s Enforcement Report published it on Aug 7, 2013.
- FDA terminated it on Oct 23, 2013.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Accelerated Care Plus Corporation, of Reno, NV.
- 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 19,710 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.