Lower riskMedical device recall · FDA · Published August 6, 2021
Smiths Medical NORMOFLO Irrigation Warming Sets: Aluminum Leaching Risk
Smiths Medical recalls NORMOFLO Irrigation Warming sets (models IR-40, IR-500, IR-600, IRI-600, IRI-600B, IR-700) due to potential aluminum leaching with blood products and longer use. Consumers should check their product codes.
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.
Take action
Contact the company
📍Recalling firmSmiths Medical ASD Inc.6000 Nathan Ln N · Minneapolis, MN 55442-1690
✎ GovInfoNow plain-language explainer
Smiths Medical is recalling NORMOFLO Irrigation Warming administration sets (models IR-40, IR-500, IR-600, IRI-600, IRI-600B, IR-700) because using them with certain blood products or longer durations may cause harmful aluminum levels. This could pose health risks if the sets are used incorrectly. Read more at govinfonow.com/recall/62035-smiths-medical-normoflo-irrigation-warming-sets-aluminum-leaching-risk.
“Smiths Medical NORMOFLO Irrigation Warming Sets: Aluminum Leaching Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62035-smiths-medical-normoflo-irrigation-warming-sets-aluminum-leaching-risk. Based on FDA recall #Z-2377-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2377-2021%22&limit=1).
The FDA announced on August 6, 2021, that Smiths Medical ASD Inc. is recalling NORMOFLO Irrigation Warming administration sets due to potential aluminum leaching hazards. The agency issued recall number Z-2377-2021 for the voluntary Class I recall affecting approximately 519,250 units distributed nationwide and internationally.
How to tell if you have it
Brand: Smiths Medical
Product: NORMOFLO Irrigation Warming administration set (disposable)
Distribution: US Nationwide and PR; Austria, Australia, Belgium, Switzerland, Canada, Germany, Spain, Finland, France, United Kingdom, Greece, Hong Kong, Hungary, Ireland, Italy, Kuwait, Luxembourg, Netherlands, New Zealand, Panama, Poland, Portugal, Sweden, Turkey, Venezuela, South Africa
The hazard
The recall cites the potential for harmful levels of aluminum leaching when using lower flow rates with certain solutions and blood products over longer durations. The FDA classified this as a Class I recall, indicating the highest degree of danger.
Context
GovInfoNow's records show Smiths Medical ASD, Inc. has 73 other recalls on record since June 5, 2017. Recent Smiths Medical recalls include CADD-Solis Infusion Pumps (April 10, 2025) involving thermal damage and false alarm risks, and a CADD Solis HSPCA Pump recall (April 10, 2025) regarding wireless connection alarms. Other recent recalls of similar products include Medline medical procedure kits with Strykeflow 2 irrigation leak risk (December 16, 2025), B Braun Medical Blood Set Recall for medication backflow risk (October 29, 2025), and ICU Medical Hotline Fluid Warming Set Recall for leakage risk (June 24, 2026).
How to tell if you have this one
Check the product code on the set: IR-40, IR-500, IR-600, IRI-600, IRI-600B, or IR-700. These models were sold with specific product codes listed in the recall notice.
Brand
Smiths Medical
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class I
Status
Ongoing
Distribution
US Nationwide Distribution and PR OUS distribution in - Austria, Australia, Belgium, Switzerland, Canada, Germany, Spain, Finland, France, United Kingdom, Greece, Hong Kong, Hungary, Ireland, Italy, Kuwait, Luxembourg, Netherlands, New Zealand, Panama, Poland, Portugal, Sweden, Turkey, Venezuela, South Africa
Recall number
Product, codes & lots
Quantity
Z-2376-2021
NORMOFLO Irrigation Fluid Warmer Models H-1100 and H-1129; Model H-1100: Product Codes CON-H1100, H-1100, H-1100-ES-115V, H-1100-ES-230V, H-1100-FR-230V, H-1100-INT-230, H-1100-IT-230V, H-1100-NL-230V H-1100-SV-230V, H-1100-UK-230 Model H-1129: Product Code H-1129
913
Z-2377-2021
NORMOFLO Irrigation Warming administration set (disposable), Models IR-40, IR-500, IR-600, IRI-600, IRI-600B, IR-700; Model IR-40: Product Code IR-40 Model IR-500: Product Code IR-500 Model IR-600: Product Code IR-600 Model IRI-600: Product Code IRI-600 Model IRI-600B: Product Code IRI-600B Model IR-700: Product Code IR-700
519,250
Based on the official FDA remedy
What to do — step by step
Check Product Code
Look for the product code on the set: IR-40, IR-500, IR-600, IRI-600, IRI-600B, or IR-700.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “US Nationwide Distribution and PR OUS distribution in - Austria, Australia, Belgium, Switzerland, Canada, Germany, Spain, Finland, France, United Kingdom, Greece, Hong Kong, Hungary, Ireland, Italy, Kuwait, Luxembourg, Netherlands, New…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 40 days after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2377-2021 (August 6, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2377-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.