Medical connector recalled due to manufacturing housing gap defect
ICU Medical is recalling MicroClave Clear Neutral Connectors used in intravascular catheters due to a manufacturing defect that creates a visible gap between housing parts.
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 a Class II medical device with a structural manufacturing defect that poses risk of improper function in a critical care application. The source does not report illnesses or injuries, meeting the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
ICU Medical, Inc. is recalling MicroClave Clear Neutral Connectors, bidirectional connectors used as accessories to intravascular catheters placed in veins or arteries. Approximately 5,795,989 units of affected connectors were distributed across all US states, territories, and to over 26 countries internationally.
The recall is due to a manufacturing defect resulting in a visible gap between the connector's top and bottom housing.
The affected units can be identified using the specific product numbers, lot numbers, and UDI codes provided in the official FDA recall notice.
The recalled product
- Product
- MicroClave Clear Neutral Connector. A bidirectional connector used as an accessory to an intravascular catheter placed in the vein or artery.
- Manufacturer
- ICU Medical, Inc.
- Affected units
- 5,795,989
Distribution
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 →Related recalls
Same manufacturer · ICU Medical, Inc.
See all →- HighICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- HighICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- HighICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- ModerateICU Medical Recalls IV Administration Sets with Drip Chamber Specks
FDA (Devices) · 2026-09-23
- ModerateICU Medical Recalls Oncology Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
Same hazard · manufacturing defect
See all →- ModerateBoston Scientific Recalls NaviFlex LW Pusher and Advx Panc. Stent
FDA (Devices) · 2026-10-21
- ModerateCook Williams Cystoscopic Injection Needles Recalled for Manufacturing Defect
FDA (Devices) · 2026-10-21
- ModerateNeuronetics Recalls NeuroStar Advanced Therapy Systems Due to Non-Conforming Cables
FDA (Devices) · 2026-10-21
- HighBeak & Skiff Alcohol Antiseptic Sanitizer recalled for acetaldehyde contamination
FDA (Drugs) · 2026-10-14
- ModerateCustom Interventional Pain Management Recalls Mastisol Skin Adhesive Trays
FDA (Devices) · 2026-10-07
Similar recalls
- HighICU Medical Recalls CLAVE Neutron Connectors Due to Manufacturing Defect
FDA (Devices) · 2020-10-28
- HighICU Medical Recalls NanoClave Connectors Due to Manufacturing Defect
FDA (Devices) · 2020-10-28
- SevereICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaking
FDA (Devices) · 2014-01-15
- HighICU Medical Recalls NanoClave Needleless Connectors Due to Potential Leaking
FDA (Devices) · 2014-01-15
- HighICU Medical Recalls NanoClave Sets Due to Potential Seal Defect
FDA (Devices) · 2020-10-28
- HighICU Medical Recalls NanoClave Needleless Connectors Due to Potential Leaks
FDA (Devices) · 2014-01-15