The Recall Desk
ModerateFDA (Devices)·Z-0595-2023·Announced 2022-12-21

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.

What this means for you

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
Category
Medical Device — Neurological Device
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

Distributed in 23 states:

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.

See all 156 products in this recall →

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