The Recall Desk
ModerateFDA (Devices)·Z-0600-2023·Announced 2022-12-21

FDA Issues Voluntary Recall of DeRoyal BASIC NEURO PACK Medical Device Kits

DeRoyal Industries has voluntarily recalled 304 kits of the BASIC NEURO PACK (REF 89-7523.16) across 23 states. The recall is ongoing.

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: This is an FDA Class II voluntary recall initiated by the manufacturer with no reported illnesses, injuries, or hospitalizations. Under the rubric, voluntary recalls without reported adverse health events are classified as Moderate.

Plain-English summary

DeRoyal Industries Inc. has voluntarily initiated a recall of the BASIC NEURO PACK, REF 89-7523.16. The recall affects 304 kits distributed across 23 states. The specific reason for the recall has not been disclosed in the FDA notification.

The affected lot numbers are Lot 57227388 (expiration 5/1/2026) and Lot 57466371 (expiration 11/1/2026). The product has been distributed to healthcare facilities in 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 providers and facilities that have received this product should stop using the affected lots and contact DeRoyal Industries for instructions on return or replacement. Patients who have received medical care involving this product should consult with their healthcare provider if they have concerns.

The recalled product

Product
DeRoyal BASIC NEURO PACK, REF 89-7523.16
Manufacturer
DeRoyal Industries Inc
Category
Medical Device — Neurological Surgical Supply
Affected units
304

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 57227388 exp 5/1/2026
  • Lot 57466371 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 →

Related recalls

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