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Cardiac Catheterization Kit

FDA product code OES · Class 2 · Cardiovascular

15,270
Registered devices
481
Adverse events
92
Recalls
0
510(k) clearances

Devices with this code

Medline Industries, Inc. — MEDLINE INDUSTRIES, INC.CARDINAL HEALTH — Cardinal Health 200, LLCMedline Industries, Inc. — MEDLINE INDUSTRIES, INC.Halyard — AVID MEDICAL, INC.Medline Industries, Inc. — MEDLINE INDUSTRIES, INC.AVID TruCustom — AVID MEDICAL, INC.Halyard — AVID MEDICAL, INC.Medline Industries, Inc. — MEDLINE INDUSTRIES, INC.Medline Industries, Inc. — MEDLINE INDUSTRIES, INC.Medline Industries, Inc. — MEDLINE INDUSTRIES, INC.Halyard — AVID MEDICAL, INC.CARDINAL HEALTH — Cardinal Health 200, LLCAVID TruCustom — AVID MEDICAL, INC.Halyard — AVID MEDICAL, INC.CARDINAL HEALTH — Cardinal Health 200, LLCCARDINAL HEALTH — Cardinal Health 200, LLCMEDLINE INDUSTRIES, INC. — MEDLINE INDUSTRIES, INC.Medline Industries, Inc. — MEDLINE INDUSTRIES, INC.AVID TruCustom — AVID MEDICAL, INC.AVID TruCustom — AVID MEDICAL, INC.Medline Industries, Inc. — CENTURION MEDICAL PRODUCTS CORPORATIONHalyard — AVID MEDICAL, INC.Medline Industries, Inc. — MEDLINE INDUSTRIES, INC.Medline Industries, Inc. — MEDLINE INDUSTRIES, INC.

Recent recalls

DateFirmReason
2026-07-10Medline Industries, LPKits contain a potentially contaminated component which were recalled by the manufacturer
2026-06-17Windstone Medical Packaging, Inc.Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions (AMS) convenience kits containing Elevaris Lidocaine HC
2026-05-28Medline Industries, LPKits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injec
2026-05-28Medline Industries, LPKits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injec
2026-05-21Medline Industries, LPThe kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocai
2026-05-19AVID Medical, Inc.Defects in the silicone seal, which may result in "doming" of the silicone seal due to improper sealing, potentially leading to fluid occlusion or leakage.
2026-05-04Medline Industries, LPDuring an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularitie
2026-04-30AVID Medical, Inc.Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the manufacturer due to presence of particulates within fluid
2026-04-30AVID Medical, Inc.Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the manufacturer due to presence of particulates within fluid
2026-04-27Medline Industries, LPKits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for applicat

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