DeRoyal BASIC NEURO PACK Medical Device Recall with Unspecified Reason
DeRoyal Industries is recalling 288 BASIC NEURO PACK medical device kits distributed across 23 U.S. states. The reason for the recall is not specified in available 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: FDA Class II voluntary recall with no reported hospitalizations, injuries, or illnesses. The manufacturer initiated this precautionary recall, and the specific hazard is not documented in available sources, limiting severity assessment.
Plain-English summary
DeRoyal Industries Inc is recalling its BASIC NEURO PACK (Reference 89-7523.15), a medical device kit. A total of 288 kits are affected, 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 FDA classified this as a Class II recall initiated voluntarily by the manufacturer on November 3, 2022. However, the specific reason for the recall is not documented in the available FDA sources.
The affected product lots are: Lot 56611821 (expiration August 1, 2026) and Lot 56881417 (expiration September 1, 2026). The recall status is ongoing as of the most recent update.
The recalled product
- Product
- DeRoyal BASIC NEURO PACK, REF 89-7523.15
- Manufacturer
- DeRoyal Industries Inc
- Affected units
- 288
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 56611821 exp 8/1/2026
- Lot 56881417 exp 9/1/2026
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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