FDA Class II Recall: DeRoyal NEURO PACK medical device kits
DeRoyal Industries recalled 270 NEURO PACK kits (REF 89-10682.02) distributed across 23 US states. The specific reason for the recall was not disclosed in the FDA notice.
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: Voluntary, firm-initiated FDA Class II medical device recall with no reported illnesses, injuries, or specific hazard disclosed in the source material.
Plain-English summary
DeRoyal Industries, Inc. issued a voluntary recall of 270 kits of the DeRoyal NEURO PACK (REF 89-10682.02), a medical device classified as FDA Class II. The recall affected units 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 FDA notice does not specify the reason for the recall. The affected lot numbers are: Lot 56225794 (expiration 12/1/2023), Lot 56619110 (expiration 9/1/2023), Lot 57227898 (expiration 4/11/2024), and Lot 57927051 (expiration 5/1/2024). The recall was initiated on November 3, 2022, and remains ongoing.
Consumers and healthcare facilities with affected NEURO PACK kits should contact DeRoyal Industries for instructions on product handling or replacement. Additional information is available through the FDA online recall database using recall number Z-0698-2023.
The recalled product
- Product
- DeRoyal NEURO PACK, REF 89-10682.02
- Manufacturer
- DeRoyal Industries Inc
- Affected units
- 270
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 (4)
- Lot Numbers: Lot 56225794 exp 12/1/2023
- Lot 56619110 exp 9/1/2023
- Lot 57227898 exp 4/11/2024
- Lot 57927051 exp 5/1/2024
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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