Merit Medical Convenience Kits With Recalled Syringes Pose Quality Defect Risks
Merit Medical convenience kits containing recalled syringes are subject to a nationwide recall due to quality defects including leaks and breakage that may pose risks to patient health.
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 an FDA Class II medical device recall involving identified quality defects (leaks, breakage) in syringes used for clinical fluid withdrawal. No illnesses or injuries have been reported, and the stated risk is theoretical rather than documented, placing this at the High level per the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Merit Medical Systems, Inc. is recalling various medical convenience kits that contain plastic syringes affected by an FDA safety alert issued on March 19, 2024. The recalled kits include multiple models identified in the FDA recall notice.
Quality defects including leaks, breakage, and other issues have been identified in the recalled syringes. These defects may pose a risk to patient health, particularly given that these kits are used to withdraw and collect fluids from the body.
The recall affects approximately 138,471 units with U.S. nationwide distribution across all states and the District of Columbia. Detailed product model numbers and lot codes are provided in the FDA recall notice Z-2565-2024.
Healthcare providers and individuals with recalled kits should immediately stop using the affected products and contact Merit Medical Systems, Inc. for instructions on obtaining replacements.
The recalled product
- Product
- Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K10/K10-PI (Custom Waste Management Kit), REF: K10T-05815 K10T-05816 K10-04722C K10-03591KP K10-05530 K10-04291AP K10-04386CP K10T-05227 K10-05120P…
- Manufacturer
- Merit Medical Systems, Inc.
- Affected units
- 138,471
Distribution
Part of a larger recall action
This product is one of 23 recalled by Merit Medical Systems, 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.
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