The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1576-2021·Announced 2021-05-19

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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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

Distributed nationwide across the United States.

The notice also names 39 states specifically:

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 →

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