Merit Medical Convenience Kits Recalled Due to Defective Syringes
Merit Medical convenience kits containing recalled plastic syringes have quality issues including leaks and breakage that may pose risks during vascular and cardiac procedures. Approximately 5,700 affected kits were distributed nationwide.
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: FDA Class II medical device recall for quality-defective syringes (leaks and breakage) used in high-risk vascular and cardiac interventional procedures. No illnesses or injuries have been reported, and the hazard is potential rather than realized. This meets the rubric criterion for High: risk-of-harm products where injury has not yet been reported.
Plain-English summary
Merit Medical Systems, Inc. has recalled various medical convenience kits that contain plastic syringes manufactured by Jiangsu Shenli Medical Production Co. Ltd. The recalled kits include Custom Procedure Kits used for angiography and angioplasty procedures. Approximately 5,700 kits have been affected.
The FDA identified quality issues with the plastic syringes, including leaks and breakage. These defects may pose a risk to patient health, particularly during vascular and cardiac interventional procedures where device reliability is critical.
The affected kits were distributed nationwide across all U.S. states. Healthcare facilities that received these kits should discontinue use immediately and contact Merit Medical Systems for instructions regarding replacement or return.
This recall was prompted by an FDA Safety Alert issued on March 19, 2024, regarding concerns with plastic syringes from this manufacturer.
The recalled product
- Product
- Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Custom Procedure Kit (Angiography/Angioplasty kit), REF: OPT0242-00 S1279-01 S2953 S2960 S6002 To support various vascular or cardiac diagnostic and…
- Manufacturer
- Merit Medical Systems, Inc.
- Affected units
- 5,700
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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