Convenience kits by Merit Medical recalled for syringe defects
Merit Medical convenience kits containing defective syringes have been recalled nationwide. Identified quality issues including leaks and breakage may pose risks during cardiac and vascular 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: FDA Class II recall of medical devices used in critical cardiac and vascular procedures. Identified quality defects (leaks and breakage) present a risk of harm to patients. No illnesses or injuries have been reported, placing this at High rather than Severe severity.
Plain-English summary
Merit Medical Systems, Inc. has recalled convenience kits containing syringes manufactured by Jiangsu Shenli Medical Production Co. Ltd. The kits are used for cardiac and vascular diagnostic and interventional procedures.
The recalled syringes have been identified with quality issues including leaks and breakage. These defects may pose a risk to patient health. The recall was prompted by an FDA Safety Alert issued on March 19, 2024.
The affected kits were distributed nationwide to healthcare facilities across all U.S. states.
The recalled product
- Product
- Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K12T/12PI (Custom Pressure Monitoring Kit), REF: K12-03846 K12-04185A K12-03447 K12M-02489 K12-10056 K12-02489A K12-02097B K12-12335 K12-12192P…
- Manufacturer
- Merit Medical Systems, Inc.
- Affected units
- 34,197
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.
See all 23 products in this recall →Related recalls
Same manufacturer · Merit Medical Systems, Inc.
See all →- ModerateMerit Medical Systems Recalls Scout MD Delivery Systems Due to Deployment Issues
FDA (Devices) · 2026-10-21
- HighEmbosphere Microspheres Recalled Due to Packaging Sterility Concerns
FDA (Devices) · 2026-10-07
- HighSplashwire hydrophilic guide wire pouches have unsealed portions
FDA (Devices) · 2026-06-24
- ModeratePhilips Bridge Prep Kit catheter may experience resistance during advancement
FDA (Devices) · 2026-05-06
- ModeratePhilips Bridge Prep Kit catheter may experience resistance during advancement
FDA (Devices) · 2026-05-06
Same hazard · leakage
See all →- SevereDraeger VentStar Resus Neo Neonatal Breathing Circuit Recall
FDA (Devices) · 2026-10-07
- HighConvaTec Esteem Body Soft Convex Urostomy Pouches Recalled for Leakage
FDA (Devices) · 2026-08-26
- SevereStryker AHTO Tube Set Packaging Recalled for Handpiece Leaking
FDA (Devices) · 2026-08-12
- SevereMedtronic Perfusion Systems Recalls EOPA Elongated One-Piece Arterial Cannula Model 77522
FDA (Devices) · 2026-08-05
- HighICU Medical Recalls Hotline Fluid Warming Sets Due to Leakage Risk
FDA (Devices) · 2026-07-29
Similar recalls
- HighConvenience kits recalled for containing defective medical syringes
FDA (Devices) · 2024-09-25
- HighMedline Convenience Kits With Syringes Recalled for Quality Defects
FDA (Devices) · 2024-09-18
- HighMedline Medical Convenience Kits with Plastic Syringes Recalled Due to Leaks and Breakage
FDA (Devices) · 2024-09-18
- HighMedline Medical Convenience Kits with Defective Syringes Recalled
FDA (Devices) · 2024-09-18
- HighMedical Convenience Kits Recalled for Syringe Leaks and Breakage
FDA (Devices) · 2024-09-18
- HighMedical Convenience Kits with Defective Plastic Syringes Recalled
FDA (Devices) · 2024-09-04