ICU Medical, Inc. recalls
25 recalls.
- CADD Yellow Medication Cassette Reservoir with NRFit connector US Product Codes:... recall (ICU Medical, Inc.)
Medical deviceClass IIReported September 23, 2026 · Reservoirs may exhibit medication leakage at the joint between luer connector and tubing. Issue could result in delay or interruption of therapy, under... - IV Sets with drip chambers recall (ICU Medical, Inc.)
Medical deviceClass IIReported September 23, 2026 · Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl... - IV Sets with drip chambers recall (ICU Medical, Inc.)
Medical deviceClass IIReported September 23, 2026 · Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl... - IV Sets with drip chambers recall (ICU Medical, Inc.)
Medical deviceClass IIReported September 23, 2026 · Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl... - IV Sets with drip chambers recall (ICU Medical, Inc.)
Medical deviceClass IIReported September 23, 2026 · Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl... - Oncology sets with drip chambers recall (ICU Medical, Inc.)
Medical deviceClass IIReported September 23, 2026 · Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl... - Oncology sets with drip chambers recall (ICU Medical, Inc.)
Medical deviceClass IIReported September 23, 2026 · Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl... - IV Non-Dedicated Gravity Administration Sets with drip chambers recall (ICU Medical, Inc.)
Medical deviceClass IIReported September 23, 2026 · Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl... - Plum administration sets recall (ICU Medical, Inc.)
Medical deviceClass IIReported September 23, 2026 · Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl... - Hotline Fluid Warming Set recall (ICU Medical Inc.)
Medical deviceClass IIReported July 29, 2026 · ICU Medical became aware of an increased likelihood of leakage in specific Lots of L-70 HOTLINE Fluid Warming Sets due to potentially inadequate solvent... - ICU Medical Plum Solo Precision IV Pump recall (ICU Medical, Inc.)
Medical deviceClass IIReported July 22, 2026 · In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at... - ICU Medical Plum Duo Infusion Pump recall (ICU Medical, Inc.)
Medical deviceClass IIReported July 22, 2026 · In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at... - Plum Duo Precision IV Pump recall (ICU Medical, Inc.)
Medical deviceClass IIReported June 17, 2026 · Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and... - Plum Duo Infusion Pump recall (ICU Medical, Inc.)
Medical deviceClass IIReported June 17, 2026 · Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and... - Plum Solo Precision IV Pump recall (ICU Medical, Inc.)
Medical deviceClass IIReported June 17, 2026 · Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and... - Oncology Kit w/60" recall (ICU Medical, Inc.)
Medical deviceClass IIReported May 27, 2026 · Oncology sets/closed system transfer devices with extension sets may leak resulting in therapy delayed if noticed and corrected during setup, but if the leak... - ICU Medical Plum Solo Precision IV Pump recall (ICU Medical, Inc.)
Medical deviceClass IIReported January 28, 2026 · Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. The programmed... - ICU Medical Plum Duo Precision IV Pump recall (ICU Medical, Inc.)
Medical deviceClass IIReported January 28, 2026 · Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. The programmed... - ICU Medical Plum Duo Infusion Pump recall (ICU Medical, Inc.)
Medical deviceClass IIReported January 28, 2026 · Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. The programmed... - Tego Connector: REF: 011-D1000 recall (ICU Medical, Inc.)
Medical deviceClass IIReported January 28, 2026 · Needle free access device intended as accessory to vascular access used in hemodialysis or accessory to intravascular administration sets has a silicone seal... - Portex Spinal Tray recall (ICU Medical Inc.)
Medical deviceClass IIReported January 21, 2026 · Affected lots of syringes may have a crack on the syringe collar, which may lead to delayed or repeated blood draw/fluid delivery. This issue may also lead to... - Pulsator Arterial Blood Sampling Kit recall (ICU Medical Inc.)
Medical deviceClass IIReported January 21, 2026 · Affected lots of syringes may have a crack on the syringe collar, which may lead to delayed or repeated blood draw/fluid delivery. This issue may also lead to... - Plum Duo Infusion System recall (ICU Medical, Inc.)
Medical deviceClass IIReported January 21, 2026 · ICU Medical received one lot of defective primary speakers from our supplier that may fail to produce an audible sound. If the primary speaker in your Plum Duo... - LifeShield Drug Library Management recall (ICU Medical, Inc.)
Medical deviceClass IIReported December 31, 2025 · Software issue only allows Concentration Limits to be defined to one digit of precision past the decimal point (0.1) instead of three digits (0.001). If the... - LifeShield Drug Library Management recall (ICU Medical, Inc.)
Medical deviceClass IIReported December 31, 2025 · For certain customers, the Change Summary review option ceases to operate as expected for any migrated library after the migration has been completed. Users...