The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0673-2023·Announced 2022-12-21

DeRoyal NEURO PACK medical device recalled by manufacturer across United States

DeRoyal Industries has voluntarily recalled 162 NEURO PACK neurological medical device kits distributed across 23 U.S. states. The 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: This is a Class II FDA medical device recall initiated voluntarily by the manufacturer with no reported illnesses or injuries mentioned in the source documentation. Voluntary precautionary recalls are classified as Moderate severity.

Plain-English summary

DeRoyal Industries Inc. has recalled the NEURO PACK, Reference Number 89-10171.03, a medical device kit. A total of 162 kits were distributed across 23 U.S. states including 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 recall was initiated voluntarily by the firm on November 3, 2022, and remains ongoing as of December 21, 2022. Customers were notified through multiple channels including email, fax, letter, press release, telephone contact, and direct visit. The specific reason for the recall has not been disclosed in available documentation.

Consumers who received NEURO PACK kits bearing Lot Numbers 55790353 (expiration April 1, 2026) or 56387785 (expiration May 1, 2026) should follow instructions provided by DeRoyal Industries Inc. For specific guidance on the recall, affected customers should contact the manufacturer using information from their original notification.

The recalled product

Product
DeRoyal NEURO PACK, REF 89-10171.03
Manufacturer
DeRoyal Industries Inc
Category
Medical Device — Neurological Device
Affected units
162

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 (2)

  • Lot Numbers: Lot 55790353 exp 4/1/2026
  • Lot 56387785 exp 5/1/2026

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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