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Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

FDA product code DTL · Class 2 · Cardiovascular

1,384
Registered devices
2,152
Adverse events
59
Recalls
137
510(k) clearances

Devices with this code

Connector — LIVANOVA USA, INC.Merit® Manifold — Merit Medical Systems, Inc.DeRoyal — DEROYAL INDUSTRIES, INC.Cook — COOK INCORPORATEDAccess-9™ — Merit Medical Systems, Inc.NAMIC — NAVILYST MEDICAL, INC.NAMIC — MEDLINE INDUSTRIES, INC.MSI Precision Specialty Instruments — Med Saver, Inc.Demax — Beijing Demax Medical Technology Co., Ltd.Smart Connector — LIVANOVA USA, INC.DLP® — MEDTRONIC, INC.NAMIC — MEDLINE INDUSTRIES, INC.NAMIC — MEDLINE INDUSTRIES, INC.GUARDIAN — TELEFLEX INCORPORATEDNAMIC — ANGIODYNAMICS, INC.Medline Industries, Inc. — MEDLINE INDUSTRIES, INC.DeRoyal — DEROYAL INDUSTRIES, INC.Arterial Extensions 12" PVC Extension Tube — ARGON MEDICAL DEVICES, INC.Medline Industries, Inc. — MEDLINE INDUSTRIES, INC.Passage® — Merit Medical Systems, Inc.DeRoyal — DEROYAL INDUSTRIES, INC.Cook — COOK INCORPORATEDMedline Industries, Inc. — MEDLINE INDUSTRIES, INC.Stopcock — ARGON MEDICAL DEVICES, INC.

Recent 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 i
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 inconv
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 bee
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 c

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.