Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
DeRoyal Sterile Custom Sterile Custom Surgical Kits containing 3M DuraPrep 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 Sterile Custom Surgical Kits containing 3M DuraPrep (TM) Surgical Solution, Catalog No. 8630, Lot Nos: 2016-09EE or 2016-09EF, or 2016-09EG, or Catalog No. 863, Lot No. 2016-08DC: TOTAL JOINT PACK A&B, REF 89-5720.04; PACEMAKER PACK, REF 89-6717.03
Quantity: N/A
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