The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0642-2023·Announced 2022-12-21

Medical device NEURO PACK subject to nationwide voluntary recall

DeRoyal Industries has issued a voluntary recall of 45 kits of the NEURO PACK medical device. The specific reason for the recall was not disclosed by the manufacturer.

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: Voluntary recall of a Class II medical device with no reported adverse events or disclosed hazard. The source lists only a placeholder reason (XXX), consistent with a precautionary firm-initiated recall.

Plain-English summary

DeRoyal Industries Inc is recalling 45 kits of the NEURO PACK medical device (Reference 89-9253.09, Lot 57760211, expiration 3/1/2025). This Class II device recall was initiated voluntarily by the manufacturer on November 3, 2022. The specific reason for the recall was not disclosed in the available source documentation.

The recalled kits were distributed to healthcare facilities across 23 U.S. 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 manufacturer notified affected recipients through multiple channels including email, fax, letter, press release, telephone, and in-person facility visits.

Healthcare providers and medical facilities in the affected states that received this product should contact DeRoyal Industries Inc to determine whether they have received recalled units and for guidance on appropriate next steps. As of the most recent report date in December 2022, the recall status remains ongoing.

The recalled product

Product
DeRoyal NEURO PACK, REF 89-9253.09
Manufacturer
DeRoyal Industries Inc
Category
Medical Device
Affected units
45

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 57760211 exp 3/1/2025

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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