The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2568-2024·Announced 2024-08-21

Merit Medical convenience kits recalled for syringe leaks and breakage risks

Merit Medical is recalling convenience kits containing syringes with quality defects including leaks and breakage. The recalled kits may pose a risk to patients undergoing vascular and cardiac procedures.

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 a risk-of-harm medical device recall where quality issues (leaks and breakage) in syringes used for critical vascular and cardiac procedures may pose a risk to patient health. No illnesses, injuries, or deaths have been reported, meeting the criteria for High severity as a risk-of-harm product without reported injury.

Plain-English summary

Merit Medical Systems, Inc. is recalling various convenience kits that contain plastic syringes manufactured by Jiangsu Shenli Medical Production Co. Ltd. These syringes have been identified with quality issues including leaks, breakage, and other defects. The recall affects approximately 103,369 kits across numerous product lines used in vascular and cardiac diagnostic and interventional procedures.

The recalled syringes are subject to an FDA Safety Alert issued March 19, 2024. The identified quality issues—including leaks, breakage, and other malfunctions—may pose a risk to patient health. Because these kits are used in critical vascular and cardiac procedures, equipment failures could compromise patient safety during medical interventions.

The recalled kits have been distributed nationwide throughout the United States, including all 50 states and the District of Columbia. Healthcare providers, hospitals, and medical facilities that have received these kits should cease use immediately. Patients may be affected if these recalled kits were used during their medical procedures.

Healthcare providers should contact Merit Medical Systems with any questions or to report adverse events. Individuals who have purchased these kits should not use them and should seek information on replacements or returns from the manufacturer. Any person who believes they have been harmed by use of these recalled syringes should seek immediate medical attention and report the incident to the FDA.

The recalled product

Product
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K22C (Vein Tray Angiography kit), REF: K09T-11796F K12T-01558G K12T-01558H K12T-01822 K12T-01852L K12T-02006J K12T-02054 K12T-02091G K12T-02102B…
Manufacturer
Merit Medical Systems, Inc.
Category
Medical Device — Vascular/Cardiac Kits
Hazard
Affected units
103,369

Distribution

Distributed nationwide across the United States.

The notice also names 51 states specifically:

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.

See all 23 products in this recall →

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