ICU Medical has recalled over 14 million needle-free access devices after reports of fluid leaks and potential exposure to biological contaminants. The recall affects devices distributed worldwide, including in 50 states and multiple countries. Users must stop using these devices immediately and follow recall instructions from the manufacturer.
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; may result in fluid leaks, occluded fluid flow, inability to inject/withdraw blood product, delayed/interrupted therapy, exposure to biological contaminants, air infused into the body
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact ICU Medical, Inc. or your healthcare provider for instructions. Notification method: Letter
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
The Tego Connector is a needle-free access device used in hemodialysis and other intravascular procedures. Healthcare providers and patients rely on these devices to manage vascular access safely and effectively.
The silicone seal in the Tego Connector may malfunction, leading to fluid leaks and exposure to biological contaminants. This defect can disrupt essential medical therapies and pose serious health risks to patients.
This recall is not part of a broader industry pattern.
Patients may experience delayed or interrupted therapy, which can affect their health outcomes. The urgency of addressing this recall is high due to the potential for serious complications.
Serial numbers and UDI codes can typically be found on the packaging or the device itself, usually near the base or on the label.
Expect a timeline of approximately 4-6 weeks for processing refunds or replacements once initiated.
Keep records of all communications regarding the recall, including emails and phone call notes, along with your device's model number and purchase information.
The recall includes Tego Connectors with reference numbers 011-D1000, 01C-D1000, 055-D1000, D1000, and LAT-D1000. ICU Medical distributed approximately 14,684,607 units globally. These devices were sold in the U.S. and various international markets.
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet instant alerts for recalls that affect you. Free forever.
ICU Medical recalled 64,290 Pulsator Arterial Blood Sampling Kits due to a potential crack in the syringe collar. This defect may cause blood leakage and delayed sampling. The recall affects models sold nationwide since December 2025.
ICU Medical recalled 64,290 spinal tray syringes on December 19, 2025, due to potential cracks in the syringe collar. The cracks may cause blood leakage and delays in blood draws or fluid delivery. Affected syringes were distributed nationwide across 13 states.
ICU Medical recalled its Plum Solo and Duo Infusion pumps on December 15, 2025, after reports of programming errors. The pumps can fail to flush properly after piggyback therapy, posing a serious risk to patients. Healthcare providers must stop using these devices immediately and follow recall instructions.
ICU Medical recalled Plum Duo Precision IV Pumps on December 15, 2025, after issues with programmed flush volumes could lead to violations. The recall affects models 400020403 in the U.S. and 400021003 in the Philippines. Users must stop using the device immediately and follow manufacturer instructions.
ICU Medical recalled the Plum Duo Infusion Pump on December 15, 2025, after reports of malfunctioning flush programming. The recall affects models 400020401 and 400021001 sold worldwide. This issue may pose a high risk to patient safety.
ICU Medical recalled 423 units of the Plum Duo Infusion System on December 15, 2025. Defective primary speakers may fail to produce audible alarms and alerts. This poses a high hazard risk to patients reliant on the device for medication administration.
ICU Medical recalled LifeShield Drug Library Management software on November 24, 2025. A software issue limits concentration precision to one decimal place, risking incorrect drug dosages. Users should stop using the product immediately and follow recall instructions.
ICU Medical recalled the LifeShield Infusion Safety Software Suite v2.2 on November 24, 2025. The software fails to operate as expected for migrated libraries, risking medication delivery errors. The recall affects seven customers across several states, including California and New York.