Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
NORMOFLO Irrigation Fluid Warmer Models H-1100 and H-1129 Recalled by Smiths Medical ASD Inc. Due to There is potential for harmful levels of aluminum...
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 Smiths Medical ASD Inc. directly.
Affected Products
NORMOFLO Irrigation Fluid Warmer Models H-1100 and H-1129
Quantity: 913
Why Was This Recalled?
There is potential for harmful levels of aluminum leaching when using lower flow rates with certain solutions and blood products and longer duration of use.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Smiths Medical ASD Inc.
Smiths Medical ASD Inc. has 169 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report