DeRoyal Spinal Fusion Packs Recalled for Containing Affected 3M Steri Drapes
DeRoyal procedure kits for spinal fusion are being recalled because they contain 3M Health Care Steri Drapes that have been recalled by 3M. The affected 16 kits were distributed to healthcare facilities in 23 US 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: Class II medical device recall involving surgical procedure packs used in spinal procedures; no reported illnesses or injuries, but surgical products that could impact patient safety if defective meet the criteria for high severity.
Plain-English summary
DeRoyal Industries Inc. is recalling DeRoyal SPINAL FUSION PACK (REF 89-7515.13), a surgical procedure kit used in spinal fusion procedures. The recall affects 16 kits with lot number 57197182, with an expiration date of February 1, 2026.
The kits are being recalled because they contain 3M Health Care Steri Drapes that have been subject to recall by 3M. This recall is being conducted as a precautionary measure to address the recalled drapes contained within these procedure packs.
The affected procedure packs have been distributed to healthcare facilities in 23 US 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 89-7515.13
- Manufacturer
- DeRoyal Industries Inc
- Hazard
- Affected units
- 16
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 57197182 exp 2/1/2026
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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