Aspira Pleural Drainage Catheter Insertion Tray recalled due to valve failure
Merit Medical Systems recalls the Aspira Pleural Drainage Catheter Insertion Tray due to a potential valve failure that could prevent fluid drainage. The recall affects approximately 1054 units distributed nationwide and internationally.
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: FDA Class II medical device recall with functional defect (valve failure preventing drainage) but no reported injuries, illnesses, or hospitalizations. Qualifies as risk-of-harm product without reported injury per rubric criterion.
Plain-English summary
Merit Medical Systems, Inc. has recalled the Aspira Pleural Drainage Catheter Insertion Tray 15.5F (REF: 4992509, Version A, Sterile EO) due to a potential defect in the valve assembly.
The recalled device carries a risk that valve assemblies will not open properly, which could prevent fluid from draining as intended. This is a Class II recall issued by the FDA.
The recall affects approximately 1054 units with lot numbers I2614171, I2559314, I2546596, I2614170, I2538442, I2564679, I2548181, and I2623231. The product was distributed nationwide across all US states, Puerto Rico, and internationally to France, the United Kingdom, and Mexico. This is a prescription-only medical device.
Healthcare providers and facilities that have received this product should discontinue use and contact the manufacturer for instructions on device replacement or proper handling. Patients or healthcare professionals who have used these units and have concerns should consult with their healthcare provider.
The recalled product
- Product
- Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF: 4992509, Version A, Sterile EO, Rx Only
- Manufacturer
- Merit Medical Systems, Inc.
- Hazard
- valve-malfunction
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 (9)
- Lot # I2614171
- I2559314
- I2546596
- I2614170
- I2538442
- I2564679
- I2548181
- I2623231
- UDI-DI: 00884450394946
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03
- SevereAbiomed Automated Impella Controller recalled for motor control and pump failure risks
FDA (Devices) · 2026-06-03
- HighGE APEXPRO and CARESCAPE Telemetry Systems Risk Loss of Patient Monitoring
FDA (Devices) · 2026-06-03
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03