ICU Medical Recalls 20mL Syringes Due to Potential Leakage Defect
ICU Medical is recalling specific lots of 20mL syringes with Spinning Spiros due to a molding defect that may cause leakage in the inactivated position.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a potential for small amounts of leakage, which is a functional defect but does not indicate reported serious injury or death, fitting the Moderate severity criteria for low-risk contamination or functional issues without reported harm.
Plain-English summary
ICU Medical, Inc. is recalling specific lots of REF CH2020 20mL Syringes with Spinning Spiros, Red Cap. These medical devices are used to provide access for the administration of fluids from a container to a patient's vascular system through a needle or catheter.
The recall is being issued due to a molding defect. This defect creates a potential for certain lots of spinning and non-spinning Sprios male luers to exhibit small amounts of leakage in the inactivated position.
The affected products were distributed worldwide, including nationwide in the United States and in Belgium, Canada, France, Italy, South Africa, Spain, and the United Kingdom. The specific lot numbers involved are 5109274 and 5125259. Users should check their inventory for these lot numbers and discontinue use if found.
The recalled product
- Product
- REF CH2020 20mL Syringe w/Spinning Spiros, Red Cap - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).
- Manufacturer
- ICU Medical, Inc.
- Category
- Medical Device — Syringes
- Hazard
Distribution
Part of a larger recall action
This product is one of 26 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 26 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 · leakage
See all →- HighConvaTec Esteem Body Soft Convex Urostomy Pouches Recalled for Leakage
FDA (Devices) · 2026-08-26
- SevereStryker AHTO Tube Set Packaging Recalled for Handpiece Leaking
FDA (Devices) · 2026-08-12
- SevereMedtronic Perfusion Systems Recalls EOPA Elongated One-Piece Arterial Cannula Model 77522
FDA (Devices) · 2026-08-05
- SevereABIOMED Introducer Kit 23 Fr heart pump accessory leakage risk
FDA (Devices) · 2026-07-22
- HighRapid Refill Continuous Injection System Recalled for Syringe Loosening Risk
FDA (Devices) · 2026-07-22