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
- Hazard
- Affected units
- 12
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
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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