ICU Medical Recalls Intravascular Connectors for Manufacturing Defect
ICU Medical is recalling approximately 5.8 million MicroClave Clear Connectors used in IV administration due to a manufacturing defect that creates a visible gap between the connector housing.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall involving a manufacturing defect in a connector used in intravascular administration. Although no illnesses or injuries have been reported, the defect represents a potential risk of harm if the visible gap causes connector malfunction or failure during medical use. Per the severity rubric, risk-of-harm products where injury has not yet been reported are classified as High.
Plain-English summary
ICU Medical, Inc. is recalling MicroClave Clear Neutral Connectors and related connector variants used in intravascular administration sets. Approximately 5.8 million units are affected.
The connectors are being recalled due to a manufacturing defect that results in a visible gap between the connector's top and bottom housing.
The recalled connectors have been distributed throughout the United States, including all 50 states, Washington, D.C., Guam, and Puerto Rico, as well as internationally to Austria, Bahrain, Belgium, Canada, Colombia, Estonia, France, Germany, Ireland, Israel, Italy, Japan, Kuwait, Luxembourg, Malaysia, Peru, Poland, Saudi Arabia, Slovakia, Slovenia, Spain, Sweden, Thailand, Turkey, United Arab Emirates, the United Kingdom, and Vietnam.
The recalled product
- Product
- MicroClave Clear Neutral Connector; MicroClave Clear Connector; MicroClave Clear Neutral Connector, Approx Priming Volume: 0.04 mL. Accessory for Intravascular Administration Set
- Manufacturer
- ICU Medical, Inc.
- Hazard
- Affected units
- 5,795,989
Distribution
Part of a larger recall action
This product is one of 6 recalled by ICU Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 6 products in this recall →Related recalls
Same manufacturer · ICU Medical, Inc.
See all →- HighICU Medical Recalls Hotline Fluid Warming Sets Due to Leakage Risk
FDA (Devices) · 2026-07-29
- SevereICU Medical Plum Duo Infusion Pump Software Defect Affecting Drug Delivery
FDA (Devices) · 2026-07-22
- SevereICU Medical Plum Solo Precision IV Pump May Deliver Excess Medication
FDA (Devices) · 2026-07-22
- HighPlum Duo Precision IV pumps may not display soft limit alerts
FDA (Devices) · 2026-06-17
- HighPlum Solo Precision IV pumps may not display soft limit alerts
FDA (Devices) · 2026-06-17
Same hazard · connector defect
See all →- ModerateDonJoy IceMan CLASSIC3 Cold Therapy Unit Connector Defect
FDA (Devices) · 2026-05-20
- HighCustom tubing kits recalled because high pressure tubing may trap air
FDA (Devices) · 2025-08-20
- HighDesign Options Combined Spinal/Epidural Tray Recalled for Connector Defect
FDA (Devices) · 2025-02-05
- HighInfusion Pump Alaris System PC Unit 8015 Recalled for Bent Connector
FDA (Devices) · 2024-09-25
- HighAlaris EtCO2 Module Model 8300 Recalled Due to Bent Connector
FDA (Devices) · 2024-09-25