The Recall Desk
ModerateFDA (Devices)·Z-0592-2023·Announced 2022-12-21

DeRoyal BASIC NEURO PACK procedure kits recalled due to defective Steri Drape component

DeRoyal procedure kits containing recalled 3M Health Care Steri Drapes are being recalled. Affected units were distributed across multiple US states and are identifiable by Lot 57748706.

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 recall with no reported illnesses or injuries. While the procedure pack contains a defective component, without documented harm or specific details about the defect, this falls under the category of voluntary precautionary recalls.

Plain-English summary

DeRoyal BASIC NEURO PACK (REF 89-7258.13) is a procedure pack kit containing 3M Health Care Steri Drapes. The recall affects 216 units.

The procedure packs are being recalled because they contain 3M Health Care Steri Drapes that have been subject to a recall.

The affected kits were distributed to healthcare facilities in multiple U.S. 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.

Affected units can be identified by Lot Number 57748706, with an expiration date of November 1, 2026.

The recalled product

Product
DeRoyal BASIC NEURO PACK, REF 89-7258.13
Manufacturer
DeRoyal Industries Inc
Hazard
  • defective-component

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 57748706 exp 11/1/2026

Distribution

Distribution scope not specified by the agency.