The Recall Desk
ModerateFDA (Devices)·Z-0698-2023·Announced 2022-12-21

FDA Class II Recall: DeRoyal NEURO PACK medical device kits

DeRoyal Industries recalled 270 NEURO PACK kits (REF 89-10682.02) distributed across 23 US states. The specific reason for the recall was not disclosed in the FDA notice.

What this means for you

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, firm-initiated FDA Class II medical device recall with no reported illnesses, injuries, or specific hazard disclosed in the source material.

Plain-English summary

DeRoyal Industries, Inc. issued a voluntary recall of 270 kits of the DeRoyal NEURO PACK (REF 89-10682.02), a medical device classified as FDA Class II. The recall affected units distributed across 23 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 FDA notice does not specify the reason for the recall. The affected lot numbers are: Lot 56225794 (expiration 12/1/2023), Lot 56619110 (expiration 9/1/2023), Lot 57227898 (expiration 4/11/2024), and Lot 57927051 (expiration 5/1/2024). The recall was initiated on November 3, 2022, and remains ongoing.

Consumers and healthcare facilities with affected NEURO PACK kits should contact DeRoyal Industries for instructions on product handling or replacement. Additional information is available through the FDA online recall database using recall number Z-0698-2023.

The recalled product

Product
DeRoyal NEURO PACK, REF 89-10682.02
Manufacturer
DeRoyal Industries Inc
Category
Medical Device — Neurological Equipment
Affected units
270

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 (4)

  • Lot Numbers: Lot 56225794 exp 12/1/2023
  • Lot 56619110 exp 9/1/2023
  • Lot 57227898 exp 4/11/2024
  • Lot 57927051 exp 5/1/2024

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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