FDA recalls DeRoyal NEURO PACK medical device kits across 23 states
DeRoyal Industries Inc is recalling 60 NEURO PACK medical device kits (Lot 56927104, expires May 2026) distributed across 23 US states. The reason for recall was not provided in the source documentation.
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 medical device recall with no documented reports of illness, injury, or death. The specific hazard is not disclosed in the source documentation. Voluntary recalls without incident reports are classified as Moderate severity.
Plain-English summary
DeRoyal Industries Inc is recalling 60 units of the DeRoyal NEURO PACK (Reference 89-10171.05) medical device kits. The affected lot is Lot 56927104, with an expiration date of May 1, 2026.
The specific reason for this recall has not been disclosed in available documentation. This is a Class II recall that was voluntarily initiated by the firm on November 3, 2022.
The recalled kits were distributed across 23 US 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.
Persons who have received these kits should contact DeRoyal Industries Inc directly for guidance on handling the affected product. The firm's facility is located at 200 DeBusk Lane, Powell, Tennessee 37849-4703.
The recalled product
- Product
- DeRoyal NEURO PACK, REF 89-10171.05
- Manufacturer
- DeRoyal Industries Inc
- Category
- Medical Device
- Affected units
- 60
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 56927104 exp 5/1/2026
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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