Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
DeRoyal Procedure Packs containing Smiths Medical NORMOFLO Irrigation Warming Set Recalled by Deroyal Industries, Inc. Lafollette Due to DeRoyal manufactured procedure packs containing a Smiths Medical...
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. Lafollette directly.
Affected Products
DeRoyal Procedure Packs containing Smiths Medical NORMOFLO Irrigation Warming Set
Quantity: 2880 units
Why Was This Recalled?
DeRoyal manufactured procedure packs containing a Smiths Medical NORMOFLO Irrigation Warming System which is recalled due to the potential for aluminum ions leaching into warming fluids.
Where Was This Sold?
US distribution in Florida and South Carolina.
About Deroyal Industries, Inc. Lafollette
Deroyal Industries, Inc. Lafollette has 12 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report