Medical device neuro pack recalled voluntarily by DeRoyal Industries
DeRoyal Industries voluntarily recalled 159 kits of the NEURO PACK medical device. The specific reason for the recall was not disclosed in the FDA filing.
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 initiated by the manufacturer with no reported illnesses or injuries. The specific hazard was not disclosed in the source documentation, limiting severity assessment to the classification and voluntary precautionary nature of the recall.
Plain-English summary
DeRoyal Industries Inc has voluntarily recalled 159 kits of the DeRoyal NEURO PACK (REF 89-10171.06), a neurological medical device. The recall was initiated on November 3, 2022, and the FDA classified it as Class II.
The specific reason for the recall was not disclosed in the available source documentation. DeRoyal notified affected customers through multiple channels including email, fax, letter, press release, telephone, and direct visits.
The recalled devices were 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 affected lot numbers are Lot 57184744 (expires 5/1/2026) and Lot 57685899 (expires 3/1/2024).
Customers who have received these devices should contact DeRoyal Industries Inc for further instructions regarding the recalled product.
The recalled product
- Product
- DeRoyal NEURO PACK, REF 89-10171.06
- Manufacturer
- DeRoyal Industries Inc
- Affected units
- 159
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 57184744 exp 5/1/2026
- Lot 57685899 exp 3/1/2024
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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