FDA Issues Voluntary Recall of DeRoyal BASIC NEURO PACK Medical Device Kits
DeRoyal Industries has voluntarily recalled 304 kits of the BASIC NEURO PACK (REF 89-7523.16) across 23 states. The recall is ongoing.
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 voluntary recall initiated by the manufacturer with no reported illnesses, injuries, or hospitalizations. Under the rubric, voluntary recalls without reported adverse health events are classified as Moderate.
Plain-English summary
DeRoyal Industries Inc. has voluntarily initiated a recall of the BASIC NEURO PACK, REF 89-7523.16. The recall affects 304 kits distributed across 23 states. The specific reason for the recall has not been disclosed in the FDA notification.
The affected lot numbers are Lot 57227388 (expiration 5/1/2026) and Lot 57466371 (expiration 11/1/2026). The product has been distributed to healthcare facilities in 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.
Healthcare providers and facilities that have received this product should stop using the affected lots and contact DeRoyal Industries for instructions on return or replacement. Patients who have received medical care involving this product should consult with their healthcare provider if they have concerns.
The recalled product
- Product
- DeRoyal BASIC NEURO PACK, REF 89-7523.16
- Manufacturer
- DeRoyal Industries Inc
- Affected units
- 304
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 57227388 exp 5/1/2026
- Lot 57466371 exp 11/1/2026
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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