Merit Medical Peritoneal Drainage Catheter Insertion Tray Recalled for Valve Failure
Merit Medical Systems is recalling Aspira Peritoneal Drainage Catheter Insertion Trays because valve assemblies may fail to open, potentially preventing proper fluid drainage in affected lots.
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 a risk-of-harm medical device where the valve assembly may fail to open, preventing necessary fluid drainage in a peritoneal catheter procedure. No illnesses or injuries have been reported, and the hazard is stated as a potential defect rather than confirmed cases, limiting the score to 3 per the rubric criterion for theoretical hazards without reported injury.
Plain-English summary
Merit Medical Systems, Inc. is recalling the Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F (Reference Number 4992209, Version A, sterile, Rx only). The recall involves 670 units distributed worldwide.
The affected product has been distributed across the United States, Puerto Rico, France, the United Kingdom, and Mexico. The specific lot numbers involved in this recall are I2533611, I2546597, I2559292, I2548163, and I2578001. The UDI-DI is 00884450394908.
The catheter insertion tray is being recalled due to a potential defect in the valve assemblies. These valve assemblies may fail to open properly, which could prevent fluid from draining as intended. This is a Class II medical device recall.
Healthcare facilities, providers, and patients with affected trays should contact Merit Medical Systems, Inc. or the FDA for information regarding this recall and any available replacements or corrective actions.
The recalled product
- Product
- Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992209 Version A, Sterile EO, Rx Only
- Manufacturer
- Merit Medical Systems, Inc.
- Hazard
- valve-malfunction
- drainage-obstruction
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 (5)
- Lot # I2533611
- I2546597
- I2559292
- I2548163 & I2578001
- UDI-DI: 00884450394908
Distribution
Distributed nationwide across the United States.
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