DeRoyal Spinal Fusion Packs Recalled Due to Affected Sterile Drapes
DeRoyal Industries is recalling 27 kits of its Spinal Fusion Pack due to inclusion of recalled 3M Health Care Steri Drapes. The affected lots were distributed across 23 U.S. states.
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: FDA Class II precautionary recall without reported illnesses or injuries. The product contains 3M Health Care Steri Drapes subject to a separate recall, but no patient harm has been reported.
Plain-English summary
DeRoyal Industries Inc is recalling 27 kits of its Spinal Fusion Pack (Model REF 89-7515.12) in response to an upstream recall of components supplied within the pack.
The recalled product contains 3M Health Care Steri Drapes that have been subject to a separate recall. The affected kits with lot numbers 56254211 (expiring 6/1/2026) and 56841212 (expiring 9/1/2026) 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.
Healthcare facilities that received the affected procedure packs should stop using them and contact DeRoyal Industries Inc for replacement or further instructions.
The recalled product
- Product
- DeRoyal SPINAL FUSION PACK, REF 89-7515.12
- Manufacturer
- DeRoyal Industries Inc
- Hazard
- Affected units
- 27
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 (2)
- Lot Numbers: Lot 56254211 exp 6/1/2026
- Lot 56841212 exp 9/1/2026
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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