Agency classClass IIOur severity:High FDA (Devices)·Z-1568-2021·Announced 2021-05-19

ICU Medical Recalls Spinning Spiros Male Luers Due to Molding Defect

ICU Medical is recalling specific lots of Spinning Spiros Closed Male Luers because a molding defect 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 3/5 (High).

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: The recall involves a medical device with a functional defect (leakage) that poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

ICU Medical, Inc. is recalling specific lots of REF 20130-01 Spinning Spiros Closed Male Luer, 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 an administration set’s needle or catheter.

The recall is due to a molding defect that creates a potential for small amounts of leakage in the inactivated position. The affected lots are identified by Lot Numbers 5135750 and 5142982, with expiration dates of January 1, 2026.

The products were distributed worldwide, including nationwide in the United States and in Belgium, Canada, France, Italy, South Africa, Spain, and the United Kingdom. Healthcare facilities and users should stop using the affected lots and contact ICU Medical for further instructions.

The recalled product

Product: REF 20130-01 Spinning Spiros Closed Male Luer, Red Cap - Product Usage: provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or catheter (which is inserted into a vein)
Manufacturer: ICU Medical, Inc.
Category: Medical Device — IV Administration Set Component
Hazard: leakage
molding-defect

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 →

Same manufacturer · ICU Medical, Inc.

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Same hazard · leakage