Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1820-2012·Announced 2012-06-27

NIMS Recalls Exer-Rest Brochures for Unsubstantiated Claims

Non-Invasive Monitoring Systems, Inc. is voluntarily recalling 91 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: This is a voluntary precautionary recall for minor labeling and marketing errors (unsubstantiated claims) with no reported injuries or illnesses, fitting the Moderate severity criteria.

Plain-English summary

Non-Invasive Monitoring Systems, Inc. (NIMS) is voluntarily recalling 91 copies of the USA-002 Rev A marketing brochure for the Exer-Rest device, Models AT3800 and AT4700. The recalled brochures are two-sided, tri-fold printed materials that describe the device's indications for use and operational information.

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

The affected brochures were distributed nationwide. Consumers who possess these specific brochures should stop using them for informational purposes regarding the device's health benefits.

The recalled product

Product: 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…
Manufacturer: Non-Invasive Monitoring Systems, Inc.
Category: Medical Device — Marketing Materials
Hazard: mis-labeling

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 USA-002 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 →

Same manufacturer · Non-Invasive Monitoring Systems, Inc.

See all →

Moderate
NIMS Recalls Exer-Rest Brochures for Unsubstantiated Claims
FDA (Devices) · 2012-06-27

Same hazard · mis labeling