Medical Device Recall: DeRoyal Custom Neuro Pack Kits
DeRoyal Industries is recalling 36 kits of the Custom Neuro Pack distributed across 23 US states. The specific reason for this voluntary Class II recall was not disclosed in the 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 recall with no reported illnesses, injuries, or deaths. The specific hazard was not disclosed in the source. Classified as voluntary and precautionary by the manufacturer.
Plain-English summary
The DeRoyal CUSTOM NEURO PACK, reference number 89-7353.17, has been recalled. The affected product consists of 36 kits with lot number 57678322, which expire on November 1, 2026.
DeRoyal Industries Inc initiated this voluntary Class II recall on November 3, 2022. The specific reason for the recall was not disclosed in the publicly available documentation. The affected kits were distributed to facilities in 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.
Healthcare facilities and providers who have received this product should contact DeRoyal Industries Inc for further instructions. The manufacturer initiated notification through multiple channels including email, fax, letter, press release, telephone, and direct contact.
The recalled product
- Product
- DeRoyal CUSTOM NEURO PACK, REF 89-7353.17
- Manufacturer
- DeRoyal Industries Inc
- Affected units
- 36
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 57678322 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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