The Recall Desk
HighFDA (Devices)·Z-0616-2023·Announced 2022-12-21

DeRoyal Procedure Packs Recalled for Defective Steri Drape Components

DeRoyal procedure packs containing defective 3M Steri Drapes have been recalled and distributed across the United States.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device recall of procedure packs containing defective components. No reported illnesses or injuries. Meets the criterion for High severity as a risk-of-harm product where injury has not yet been reported.

Plain-English summary

DeRoyal Industries Inc is recalling DeRoyal CUSTOM NEURO PACK (REF 89-8392.09) procedure packs that contain recalled 3M Health Care Steri Drapes.

The affected packs were distributed to medical facilities across the United States, including 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 recall involves 12 kits with Lot Number 56614271, expiring April 1, 2026.

The 3M Health Care Steri Drapes are sterile components used in surgical procedures. These components have been recalled, which necessitates the recall of any DeRoyal CUSTOM NEURO PACK kits that contain them.

The recalled product

Product
DeRoyal CUSTOM NEURO PACK, REF 89-8392.09
Manufacturer
DeRoyal Industries Inc
Category
Medical Device — Surgical Procedure Kit
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 56614271 exp 4/1/2026

Distribution

Distribution scope not specified by the agency.

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