Aspira Pleural Drainage Catheter May Fail to Drain Fluid
Merit Medical Systems is recalling 524 units of the Aspira Pleural Drainage Catheter Insertion Tray due to a defect where valve assemblies may not open, preventing fluid drainage. Affected units were distributed worldwide including across the US, France, UK, and Mexico.
What this means for you
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 recall of a medical device with a functional defect that prevents normal operation. While no illnesses or injuries have been reported, the hazard—inability to drain fluid from a pleural catheter—poses a risk of serious harm in a critical medical context. Per the severity rubric, this constitutes a risk-of-harm product where injury has not yet been reported, warranting a High severity rating.
Plain-English summary
Merit Medical Systems, Inc. is recalling the Aspira Pleural Drainage Catheter Insertion Tray 15.5F (Reference 4992507, Version A). The recall affects 524 units with lot numbers I2548172, I2568218, I2553914, I2614174, I2638785, and I2559299.
The device has a potential defect in its valve assemblies. Specifically, the valve assemblies may not open properly, which prevents fluid from draining through the catheter.
These catheter insertion trays were distributed worldwide to healthcare facilities in the United States (all states), France, United Kingdom, Mexico, and Puerto Rico.
Healthcare providers who have received these devices should stop using the affected lot numbers immediately. Facilities should check their inventory and contact Merit Medical Systems for information on replacement or return of the recalled units.
The recalled product
- Product
- Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992507, Version A, Sterile EO, Rx Only
- Manufacturer
- Merit Medical Systems, Inc.
- Hazard
- valve-malfunction
- drainage-failure
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 (7)
- Lot # I2548172
- I2568218
- I2553914
- I2614174
- I2638785
- I2559299
- UDI-DI: 00884450394915
Distribution
Distributed nationwide across the United States.
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