The FDA has posted 12 enforcement recalls of intravascular administration set devices since 2025, including 2 Class I (most serious) recalls. Most recent report: Sep 23, 2026.
Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall that does not e…
Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall.…
Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall.…
Due to discrepancies in specific attributes in the performance data for infusion sets, which may lead to inappropriate pump performance.
Specific lots of Discofix Stopcock Sets recalled due to an incorrect expiration date printed on the carton shipper label.
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 position.
Products may not have received adequate sterilization processing.
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 of enteral nutritional fluids or oral medication.
Due to engineering sample labeled "Not for Human Use" being inadvertently shipped it the U.S. market.
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 not being engaged and becoming un-attached.
Under circumstances involving exposure to particular chemicals and mechanical forces, the male luer connectors for the specified IV Administration and Extension sets may leak, crack, and/or break during use, which may r…
Needle free access device intended as accessory to vascular access used in hemodialysis or accessory to intravascular administration sets has a silicone seal which may bulge at the top, separate from the body, tear;…
Source: U.S. FDA openFDA device enforcement reports, updated continuously. Device type per the FDA's RES classification (“Set, Administration, Intravascular”). Informational only — verify against the FDA before acting.