DeRoyal Procedure Packs containing Smiths Medical NORMOFLO Irrigation… — Class I medical device recall Z-2499-2021
Terminated recall by Deroyal Industries, Inc. Lafollette, reported 2021-10-06, distributed in FL, SC. DeRoyal manufactured procedure packs containing a Smiths Medical NORMOFLO Irrigation Warming System which is r
| Recall number | Z-2499-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Deroyal Industries, Inc. Lafollette, La Follette, TN, United States |
| Recall initiated | 2021-09-02 |
| Classified | 2021-09-29 |
| Reported by FDA | 2021-10-06 |
| Terminated | 2023-12-18 |
| Distributed | FL, SC |
| Quantity | 2,880 units |
| Lot numbers | 46459298, 47042849, 47217717, 47461066, 47525103, 47696113, 48210787, 49049665, 49101769, 49215918, 49291064, 49351178, 49455989, 49683631, 50920251, 51081699, 51253374, 52004222, 52173376, 52658453, 52902866, 53216518, 53216841, 53331541, 53411946, 53598712, 53666480, 53784881, 53888656, 53964621, 54009801, 54246494, 54367035 |
| Expiration dates | 2021-10-01, 2021-11-01, 2021-12-01, 2022-01-01, 2022-02-01, 2022-03-01, 2022-04-01, 2022-04-10, 2022-05-01, 2022-07-01, 2022-08-01, 2022-09-01, 2022-10-01, 2022-11-01, 2023-01-01, 2023-03-01, 2023-08-01, 2023-10-01, 2024-02-01, 2024-09-01, 2025-01-01 |
Product
DeRoyal Procedure Packs containing Smiths Medical NORMOFLO Irrigation Warming Set
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2499-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.