DeRoyal recalls procedure packs with Smiths Medical NORMOFLO Irrigation Warming Sets due to potential aluminum ions leaching into warming fluids. Affected units include specific lot numbers from 2021-2025.
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.
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Contact the company
📍Recalling firmDeroyal Industries, Inc. Lafollette1501 E Central Ave · La Follette, TN 37766-2892
“DeRoyal Procedure Packs Recall: Aluminum Ions Leaching Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61850-deroyal-procedure-packs-recall-aluminum-ions-leaching-risk. Based on FDA recall #Z-2499-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2499-2021%22&limit=1).
The FDA announced on Sept. 2, 2021, that Deroyal Industries, Inc. Lafollette is recalling DeRoyal Procedure Packs containing Smiths Medical NORMOFLO Irrigation Warming Sets due to the potential for aluminum ions leaching into warming fluids. The recall affects 2,880 units distributed in Florida and South Carolina.
The Smiths Medical NORMOFLO Irrigation Warming System included in the packs has the potential for aluminum ions to leach into warming fluids. The FDA classified this as a Class I recall.
Context
GovInfoNow's records show Deroyal Industries, Inc. Lafollette has two other recalls on record since Feb. 4, 2020. On Feb. 6, 2020, the company recalled Deroyal Teleflex Pilling Aortic Punches due to compromised sterile packaging risk. Also on Feb. 4, 2020, DeRoyal Sterile Custom Kits with Cardinal Health Gowns were recalled due to unknown bioburden and particulate contamination. Other recent recalls of similar products include Medline medical procedure kits with Strykeflow 2 irrigation leak risk (Dec. 16, 2025), ICU Medical Hotline Fluid Warming Set Recall for leakage risk (June 24, 2026), and DeRoyal Covaderm Plus Dressing Recall for sterility risk (May 18, 2026).
How to tell if you have this one
Check for DeRoyal Procedure Packs labeled with Smiths Medical NORMOFLO Irrigation Warming Sets. Affected units have specific lot numbers listed in the recall notice, such as Lot 46459298 through Lot 54367035.
Brand
DeRoyal
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Labels
Look for DeRoyal Procedure Packs with Smiths Medical NORMOFLO Irrigation Warming Sets and check the lot numbers listed in the recall notice.
Where it went and when
Where it was distributed
Distributed in Florida and South Carolina.
Listed by the agency
Not listed
FDA distribution: “US distribution in Florida and South Carolina.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Florida, South Carolina.
Recall timeline
FDA terminated this recall 2.3 years after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
4FDA terminated the recall
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-2499-2021 (September 2, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2499-2021 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.