The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1819-2012·Announced 2012-06-27

NIMS Recalls Exer-Rest Brochures for Unsubstantiated Claims

Non-Invasive Monitoring Systems is voluntarily recalling 3,665 Exer-Rest marketing brochures nationwide because they contain unsubstantiated health claims.

The agency’s classification

FDA (Devices): Class II

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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II and involves a voluntary precautionary action regarding labeling/claims without reported injuries, fitting the Moderate severity criteria.

Plain-English summary

Non-Invasive Monitoring Systems, Inc. (NIMS) is voluntarily recalling the US-001 Rev A brochure, a two-sided tri-fold printed marketing document for the Exer-Rest device (Models AT3800 and AT4700). The recall involves 3,665 units that were distributed nationwide.

The recall was initiated because the promotional materials contain unsubstantiated direct and indirect claims. The source text does not specify the exact nature of the unsubstantiated claims or report any associated illnesses or injuries.

Consumers who possess these brochures should stop using them for informational purposes regarding the device's indications or precautions. The source text does not provide specific instructions for disposal or return, nor does it list a specific contact number for consumer inquiries beyond the general company information printed on the brochure.

The recalled product

Product
US-001 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. Ever-Rest US Brochure US-001 Rev A. Brochure…
Manufacturer
Non-Invasive Monitoring Systems, Inc.
Category
Medical Device — Marketing Materials
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Brochure US-001 Rev A

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Non-Invasive Monitoring Systems, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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