ICU Medical Recalls Sprios IV Adapters Due to Leakage Defect
ICU Medical is recalling specific lots of Sprios IV adapters 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 defect that poses a risk of harm (leakage) 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 REF 034-H2629 Sprios universal IV adapters. The recall is due to a molding defect that may cause small amounts of leakage in the inactivated position for certain lots of spinning and non-spinning Sprios male luers.
The affected product is distributed worldwide, including nationwide in the United States and in Belgium, Canada, France, Italy, South Africa, Spain, and the United Kingdom. The specific lot number is 5125301, with an expiration date of January 1, 2026.
Healthcare facilities and consumers should stop using the affected adapters and contact ICU Medical for further instructions or replacement.
The recalled product
- Product
- REF 034-H2629 Appx 1.0 ml, Adaptador universal para sistemas IV con Spiros" - 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 — IV Adapters
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.
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