Agency classClass IIOur severity:High FDA (Devices)·Z-1722-2022·Announced 2022-09-21

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.

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: 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.
Category: Medical Device — Intravascular Administration
Hazard: connector-defect
Affected units: 5,795,989

Distribution

Distributed in 53 states:

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 →

Same manufacturer · ICU Medical, Inc.

See all →

High
ICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
High
ICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
High
ICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
Moderate
ICU Medical Recalls IV Administration Sets with Drip Chamber Specks
FDA (Devices) · 2026-09-23
Moderate
ICU Medical Recalls Oncology Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23

Same hazard · connector defect