The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0617-2023·Announced 2022-12-21

FDA Class II Recall of DeRoyal CUSTOM NEURO PACK, Voluntary

DeRoyal Industries Inc is voluntarily recalling the DeRoyal CUSTOM NEURO PACK (Lot 57745880) distributed across multiple U.S. states. The specific reason for the recall is not disclosed.

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 an FDA Class II recall with no reported illnesses, injuries, or deaths. The voluntary nature and absence of adverse event reports align with a moderate severity rating for a precautionary medical device recall.

Plain-English summary

DeRoyal Industries Inc is conducting a voluntary recall of the DeRoyal CUSTOM NEURO PACK, REF 89-8392.10. This is a FDA Class II medical device recall affecting approximately 12 kits. The recall was initiated on November 3, 2022.

The specific reason for the recall was not disclosed in the available information. No illnesses or injuries have been reported. Consumers should not use the recalled product and should contact the manufacturer for instructions on return or disposal.

The recalled product was distributed to healthcare facilities in the following states: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, and Mississippi.

The recalled product

Product
DeRoyal CUSTOM NEURO PACK, REF 89-8392.10
Manufacturer
DeRoyal Industries Inc
Category
Medical Device
Affected units
12

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)

  • Lot Numbers: Lot 57745880 exp 12/1/2026

Distribution

Distributed in 23 states:

Part of a larger recall action

This product is one of 156 recalled by DeRoyal Industries 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 156 products in this recall →

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