Class I — Serious Health Hazard

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...

Date: September 2, 2021
Company: Deroyal Industries, Inc. Lafollette
Status: Terminated
Source: FDA (Device)

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.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report