DeRoyal SPINE PACK procedure kits recalled due to recalled Steri Drapes
DeRoyal SPINE PACK kits have been recalled because they contain 3M Health Care Steri Drapes components that have been previously recalled. Affected units should not be used.
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 without reported illnesses or injuries. The recall is precautionary in nature, initiated because the product contains a component that has been separately recalled.
Plain-English summary
DeRoyal SPINE PACK procedure kits (reference number 89-8361.10) have been recalled due to the inclusion of 3M Health Care Steri Drapes components that have been previously recalled.
Approximately 96 kits were distributed to healthcare facilities across 23 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. The affected lot is Lot 57745943, which has an expiration date of December 1, 2026.
Healthcare facilities and practitioners with this product should discontinue use immediately. Contact DeRoyal Industries Inc for information regarding the return or replacement of affected procedure packs.
The recalled product
- Product
- DeRoyal SPINE PACK, REF 89-8361.10
- Manufacturer
- DeRoyal Industries Inc
- Hazard
- Affected units
- 96
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 57745943 exp 12/1/2026
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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