Merit Medical convenience kits recalled for syringe leaks and breakage
Merit Medical convenience kits containing recalled syringes have quality issues including leaks and breakage that may pose a risk to patient health. The recall affects 2,388 kits 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: This FDA Class II medical device recall involves quality defects (leaks and breakage) in syringes used during patient procedures. No illnesses or injuries have been reported, and the risk is theoretical, placing it at Score 3 (High) as a risk-of-harm product without reported injury.
Plain-English summary
Merit Medical Systems, Inc. is recalling convenience kits that contain plastic syringes manufactured by Jiangsu Shenli Medical Production Co. Ltd. The recalled syringes are affected by an FDA Safety Alert issued March 19, 2024, and have been identified with leaks, breakage, and other quality issues that may pose a risk to patient health.
The affected product is the Rapid Response Waste Management System Kit (Catalog Number BRC-BAL-INT-SL/B). The recall involves 2,388 kits that were distributed nationwide across all U.S. states, territories, and the District of Columbia.
Patients and healthcare providers who have received or used these kits should contact Merit Medical Systems, Inc. for instructions on what to do.
The recalled product
- Product
- Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Rapid Response Waste Management System Kit, REF BRC-BAL-INT-SL/B An endoscope and accessories is a device used to provide access, illumination, and allow…
- Manufacturer
- Merit Medical Systems, Inc.
- Affected units
- 2,388
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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