Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of DeRoyal IndustriesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Deroyal Industries, Inc. Lafollette with 12 device recalls. The most recent is a device recall dated Sep 2, 2021: DeRoyal Procedure Packs containing Smiths Medical NORMOFLO Irrigation Warming Set.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Sep 2, 2021 | DeRoyal Procedure Packs containing Smiths Medical NORMOFLO Irrigation Warming SetClass I · DeRoyal manufactured procedure packs containing a Smiths Medical NORMOFLO Irrigation Warming System which is recalled du | Device recalls |
| Feb 6, 2020 | Teleflex Pilling Aortic Punch, 4.0mm. Sterile, Rx Only, disposable. Included as part of Intl-Cardiac Surgery Kit - Product Usage: This deviClass II · The sterile packaging has the potential to be compromised. | Device recalls |
| Feb 4, 2020 | DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC Thyroid Pack 89-6302.14Class II · Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate cont | Device recalls |
| Feb 4, 2020 | DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC Ocular Plastics Pack 89-6498.13Class II · Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate cont | Device recalls |
| Feb 4, 2020 | DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Shoulder Pack 89-4751.08Class II · Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate cont | Device recalls |
| Feb 4, 2020 | DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Outpatient Major 89-3865.12;Class II · Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate cont | Device recalls |
| Feb 4, 2020 | DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Cystoscopy Pack 89-6071.15Class II · Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate cont | Device recalls |
| Feb 4, 2020 | DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC General Pack 89-6015.16Class II · Cardinal Health gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate cont | Device recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
