Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
DeRoyal Sterile Custom Surgical Kits containing 3M DuraPrep (TM) Surgical Recalled by DeRoyal Industries Inc Due to Custom Sterile Surgical kits contain 3M DuraPrep (TM)...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact DeRoyal Industries Inc directly.
Affected Products
DeRoyal Sterile Custom Surgical Kits containing 3M DuraPrep (TM) Surgical Solution, Catalog No. 8630, Lot Nos: 2016-09EE: TOTAL KNEE A & B, REF 89-4561.11; TOTAL HIP A & B, REF 89-4562.12; PODIATRY TRAY, REF 89-3101.04; KNEE SCOPE PACK, REF 89-7744.03; KNEE PACK, REF 89-8194.02; BEACH CHAIR PACK, REF 89-8439.01; TOTAL JOINT, REF 50-12160.17; BACK TRAY, REF 50-12602.09; PACEMAKER PACK, REF 89-8381.01;
Quantity: 355 units
Why Was This Recalled?
Custom Sterile Surgical kits contain 3M DuraPrep (TM) Surgical Solution, Catalog Number 8630, Lot Number 2016-09EE which was recalled due to unintended exposure to the sterilant during package sterilization.
Where Was This Sold?
This product was distributed to 7 states: AR, FL, MN, NJ, OH, OK, SC
About DeRoyal Industries Inc
DeRoyal Industries Inc has 225 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report