DeRoyal Spinal Fusion Procedure Packs Recalled for 3M Drape Issue
DeRoyal spinal fusion procedure packs containing recalled 3M Health Care Steri Drapes are being recalled. Affected kits were distributed to healthcare facilities 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 3/5 (High).
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: This Class II medical device recall involves sterile surgical supplies where potential hazards exist but no illnesses or injuries are reported in the source documentation. The classification reflects the risk associated with surgical kits used in spinal procedures.
Plain-English summary
DeRoyal Industries Inc. is recalling approximately 30 spinal fusion procedure packs (Reference 89-7515.14, Lot 57746997, expiration date 12/1/2026) because they contain 3M Health Care Steri Drapes that have been subject to recall.
The affected procedure packs 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 recalled product
- Product
- DeRoyal SPINAL FUSION PACK, REF 89-7515.14
- Manufacturer
- DeRoyal Industries Inc
- Category
- Medical Device — Surgical Kit
- Hazard
- Affected units
- 30
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 57746997 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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