ICU Medical Recalls NanoClave Stopcock Due to Potential Leakage
ICU Medical is recalling specific lots of NanoClave Stopcocks because a small percentage of the devices may leak.
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 criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
ICU Medical, Inc. is recalling certain lots of the NanoClave Stopcock, Part No. A1000, Item No. 011-AC100. The recall involves 50 units from Lot No. 2781529. The NanoClave Stopcock is a single-use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration sets for administering fluids to patients through a cannula placed in a vein or artery.
The recall was initiated because a small percentage of the devices may leak. The affected products were distributed worldwide, including in the United States (specifically UT, TX, GA, WI, VT, NH, AL, OH, TN, IL, CA, KY, HI, and NC) and internationally to Canada, Belgium, India, Kuwait, and Australia.
Healthcare facilities and consumers should stop using the affected devices and contact ICU Medical for further instructions or a replacement.
The recalled product
- Product
- NanoClave Stopcock, Part No. A1000, Item No. 011-AC100 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the…
- Manufacturer
- ICU Medical, Inc.
- Hazard
- Affected units
- 50
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot No. 2781529
Distribution
Part of a larger recall action
This product is one of 50 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 50 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 · leakage
See all →- SevereDraeger VentStar Resus Neo Neonatal Breathing Circuit Recall
FDA (Devices) · 2026-10-07
- HighConvaTec Esteem Body Soft Convex Urostomy Pouches Recalled for Leakage
FDA (Devices) · 2026-08-26
- SevereStryker AHTO Tube Set Packaging Recalled for Handpiece Leaking
FDA (Devices) · 2026-08-12
- SevereMedtronic Perfusion Systems Recalls EOPA Elongated One-Piece Arterial Cannula Model 77522
FDA (Devices) · 2026-08-05
- HighICU Medical Recalls Hotline Fluid Warming Sets Due to Leakage Risk
FDA (Devices) · 2026-07-29
Similar recalls
- HighICU Medical NanoClave Stopcock Recalled for Potential Manufacturing Defect
FDA (Devices) · 2020-10-28
- HighICU Medical Recalls Clave Stopcock Due to Potential Manufacturing Defect
FDA (Devices) · 2020-10-28
- HighICU Medical Recalls NanoClave Stopcock Sets Due to Seal Defect
FDA (Devices) · 2020-10-28
- HighICU Medical Recalls NanoClave Connectors Due to Manufacturing Defect
FDA (Devices) · 2020-10-28
- HighICU Medical Recalls MicroClave Extension Sets Due to Leak Risk
FDA (Devices) · 2017-07-19
- HighICU Medical Recalls NanoClave Intravascular Administration Sets Due to Seal Defect
FDA (Devices) · 2020-10-28