Severity
Moderate
FDA Devices recall · Reported June 27, 2012
Non-Invasive Monitoring Systems Inc (NIMS) is voluntarily recalling promotional materials which contain unsubstantiated direct and indirect claims.
Non-Invasive Monitoring Systems, Inc. recalled USA-002 Rev A brochure is a two sided tri-fold printed marketing brochure describing the … - a moderate-severity action.
USA-002 Rev A brochure is a two sided tri-fold printed marketing brochure describing the … was recalled by Non-Invasive Monitoring Systems, Inc. in June 27, 2012. Reason: Non-Invasive Monitoring Systems Inc (NIMS) is voluntarily recalling promotional materials which contain unsub…. Check the official notice for the remedy. Verify recall #Z-1820-2012 with the FDA Devices before acting.
The recall
Non-Invasive Monitoring Systems, Inc. issued this moderate-severity FDA Devices recall-Non-Invasive Monitoring Systems Inc (NIMS) is voluntarily recalling promotional materials which contain unsub….
Sourced from official FDA Devices enforcement records. Verify recall #Z-1820-2012 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-1820-2012) was formally reported on June 27, 2012, with the manufacturer initiating the action on May 7, 2012. It is classified under Moderate severity (Class II), with a current status of Terminated. Non-Invasive Monitoring Systems, Inc. is listed as the recalling firm, operating out of Miami, FL. Federal records list the affected scope as USA-002 Rev A brochure: 91.
The documented reason for this recall is: Non-Invasive Monitoring Systems Inc (NIMS) is voluntarily recalling promotional materials which contain unsubstantiated direct and indirect claims. Distribution data in the federal record shows the product reached: Nationwide Distribution. 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, 3 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.
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. 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.
Severity
Moderate
Affected scope
USA-002 Rev A brochure: 91
Related Recalls
6
3 from same agency
USA-002 Rev A brochure is a two sided tri-fold printed marketing brochure describing the approved labeling indications for use, precautions and general operational information of the Exer-Rest device, Models AT3800 and AT4700. Brochure: "EXER-REST***A patented, FDA registered, Acceleration Therapeutics device delivering Whole Body Periodic Acceleration to the user for symptomatic relief of a wide range of complaints***Whole Body Periodic Acceleration (WBPA)***WBPA is accomplished utilizing the Ever-Rest device to move the body repetitively head to foot at approximately 140 times a minute. This repetitive motion adds pulses to your natural vascular pulse with each acceleration and deceleration of the body. These additional pulses act on the inner lining of blood vessels (endothelium) throughout the body, a process called pulsatile shear stress, to promote the release of beneficial substances (mediators). These mediators, such as nitric oxide, provide a wide range of health benefits that originate from the user's own body.***Nitric Oxide (NO) is released from endothelial cells that line the arterial walls. NO signals vascular smooth muscle to relax, thereby increasing blood flow throughout the circulation.***NiMS 4400 Biscayne Blvd., Miami, FL 33137 P 305.575.4200 F 305357534201***info@nims-inc.com www.nims-inc.com***NIMS, Acceleration Therapeutics and Exer-Rest are registered trademarks of Non-Invasive Monitoring Systems, Inc.***USA-002 Rev A***" Printed marketing brochure
Non-Invasive Monitoring Systems Inc (NIMS) is voluntarily recalling promotional materials which contain unsubstantiated direct and indirect claims.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1820-2012 |
| Date reported | June 27, 2012 |
| Date initiated | May 7, 2012 |
| Recalling firm | Non-Invasive Monitoring Systems, Inc. |
| Firm location | Miami, FL |
| Affected scope | USA-002 Rev A brochure: 91 |
| Distribution | Nationwide Distribution |
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.
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.
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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 June 27, 2012. 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 July 2026.