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DeRoyal

DEROYAL INDUSTRIES, INC. · Model 301748 · UDI-DI 00749756720168

DTL Prescription
10
510(k) clearances
2,152
Adverse events (18 deaths)
59
Recalls
144
Facilities

Description

Lines, Pressure Monitoring

Recalls

DateFirmReason
2026-03-24Medline Industries, LPMedline has identified the presence of particulate within the fluid path of the Manifolds.
2026-03-24Medline Industries, LPMedline has identified the presence of particulate within the fluid path of the Manifolds.
2026-03-24Medline Industries, LPMedline has identified the presence of particulate within the fluid path of the Manifolds.
2026-02-27Medline Industries, LPMedline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection
2025-08-04Merit Medical Systems, Inc.Hemostasis valve has a manufacturing defect and when used the valve cap may remain depressed, leading to potential leakage, which may result in procedure inconvenience and/or hemor
2025-07-25Merit Medical Systems, Inc.Due to a manufacturing issue involving the silicone quad ring where the ring is deformed or otherwise damaged and may cause a foreign body in the fluid pathway.
2024-04-08MEDLINE INDUSTRIES, LP - NorthfieldMedical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that ma
2023-04-05Boston Scientific CorporationThe firm received complaints of the Insertion Tool component being occluded, resulting in the inability to pass a guidewire through the tool.
2023-04-05Boston Scientific CorporationThe firm received complaints of the Insertion Tool component being occluded, resulting in the inability to pass a guidewire through the tool.
2022-03-01Merit Medical Systems, Inc.A design change made to a hemostasis valve to improve manufacturability caused an internal gap between the rotator and the Y-body, where the guidewire can get caught, resulting in

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.