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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
- Affected units
- 216
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
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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