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Set, Administration, Intravascular

FDA product code FPA · Class 2 · General Hospital

9,819

Registered devices

368,061

Adverse events

1,089

Recalls

1,175

510(k) clearances

Devices with this code

IMED — BQ PLUS MEDICAL CO., LTD.MiniMed™ Silhouette™ — Unomedical A/S IMED — BQ PLUS MEDICAL CO., LTD.Codan — Codan US Corporation Alaris, SmartSite — BD Switzerland Sàrl Centurion — CENTURION MEDICAL PRODUCTS CORPORATION Centurion — CENTURION MEDICAL PRODUCTS CORPORATION EXEL Huber Infusion Set — Exel International Alaris, SmartSite — BD Switzerland Sàrl Alaris, SmartSite — BD Switzerland Sàrl Medex — ICU MEDICAL, INC.FRESENIUS KABI — Codan US Corporation Tandem Mobi Autosoft 30 Kit — Tandem Diabetes Care, Inc.Merit Medical® — Merit Medical Systems, Inc.MaxZero — BD Switzerland Sàrl SafeDAY™ — B. BRAUN MEDICAL INC.Codan — Codan US Corporation Codan — Codan US Corporation Smart Port CT — Angiodynamics, Inc.GCB Medical Supply — GCB MEDICAL LLC Medcomp — Jiangsu Caina Medical Co.,Ltd VYGON — Vygon Corporation Port Access Needle — Bard Access Systems, Inc.CADD — ICU MEDICAL, INC.

Recent recalls

Date	Firm	Reason
2026-08-19	BD SWITZERLAND SARL	Due to discrepancies in specific attributes in the performance data for infusion sets, which may lead to inappropriate pump performance.
2026-08-04	B Braun Medical Inc	Specific lots of Discofix Stopcock Sets recalled due to an incorrect expiration date printed on the carton shipper label.
2026-06-30	Baxter Healthcare Corporation	Baxter received customer reports of air bubbles in the drip chamber and tubing when a pressure cuff is in use or when the tubing is flushed at the fully open po
2026-06-16	BD SWITZERLAND SARL	Due to mechanical issue with internal sterilization equipment resulting in potential underdosing of product during processing, which may have resulted in produc
2026-06-05	Medela Inc	May contain incorrect connectors and will not attach or misconnect to ENFit connections and is thus incompatible. Issue could lead to slight delay in delivery o
2026-06-04	BD SWITZERLAND SARL	Due to engineering sample labeled "Not for Human Use" being inadvertently shipped it the U.S. market.
2026-05-12	ICU Medical, Inc.	Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride
2026-05-12	ICU Medical, Inc.	Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride
2026-05-12	ICU Medical, Inc.	Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride
2026-02-17	Molded Products Inc	Molded Products, Inc. is voluntarily conducting a medical device recall of the MPC-130 See Luer Cap Set based on a confirmed complaint of the threaded sleeve no

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