DeRoyal NEURO PACK medical device recalled voluntarily by manufacturer
DeRoyal Industries Inc initiated a voluntary recall of 93 kits of the DeRoyal NEURO PACK affecting 23 U.S. states. The recall affects three lot numbers with March 1, 2025 expiration.
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, firm-initiated Class II medical device recall without reported illnesses or injuries. Per the severity rubric, voluntary precautionary recalls are classified as Moderate (Score 2).
Plain-English summary
DeRoyal Industries Inc initiated a voluntary recall of the DeRoyal NEURO PACK (REF 89-9253.07) affecting 93 kits. The recalled product was distributed to medical facilities and providers in 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 recall affects the following lot numbers, all expiring March 1, 2025: Lot 56389334, Lot 56615629, and Lot 57003940. The firm initiated the recall on November 3, 2022, and the FDA classified it as a Class II recall on December 15, 2022.
The recall was initiated voluntarily by the manufacturer. Individuals in possession of affected product should contact DeRoyal Industries Inc at its Powell, Tennessee facility for guidance on next steps.
The recalled product
- Product
- DeRoyal NEURO PACK, REF 89-9253.07
- Manufacturer
- DeRoyal Industries Inc
- Category
- Medical Device
- Affected units
- 93
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 (3)
- Lot Numbers: Lot 56389334 exp 3/1/2025
- Lot 56615629 exp 3/1/2025
- Lot 57003940 exp 3/1/2025
Distribution
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.
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