Merit Medical Convenience Kits with Defective Syringes Recalled
Merit Medical convenience kits containing defective syringes are being recalled for leaks and breakage that may pose a risk 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: FDA Class II recall of medical device syringes with identified defects (leaks and breakage). These are risk-of-harm products used in invasive medical procedures, though no illnesses or injuries have been reported.
Plain-English summary
Merit Medical Systems, Inc. is recalling various Prelude Prestige convenience kits (catalog numbers PLP-2505/A, PLP-2514/A, and PLP-2516/A) that contain plastic syringes manufactured by Jiangsu Shenli Medical Production Co. Ltd. The syringes are used to introduce pacing and defibrillator leads into the venous vasculature.
The FDA identified leaks, breakage, and other quality issues with the syringes through a Safety Alert issued on March 19, 2024. These defects may pose a risk to patient health.
Approximately 30 kits have been distributed nationwide. Affected lot numbers are I2889564, I2902220, and I2894297.
The recalled product
- Product
- Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Prelude Prestige (Introducer Catheter), REF: PLP-2505/A PLP-2514/A PLP-2516/A The introduction of various types of pacing/defibrillator leads and catheters…
- Manufacturer
- Merit Medical Systems, Inc.
- Category
- Medical Device
- Affected units
- 30
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
- HighMedline Convenience Kits Recalled Due to Defective Plastic Syringes
FDA (Devices) · 2024-09-18
- HighConvenience kits recalled for containing defective medical syringes
FDA (Devices) · 2024-09-25
- HighMedline Medical Convenience Kits Recalled for Defective Plastic Syringes
FDA (Devices) · 2024-09-18
- HighMedical Convenience Kits with Defective Plastic Syringes Recalled Worldwide
FDA (Devices) · 2024-09-18
- HighMedline Medical Convenience Kits with Defective Plastic Syringes Recalled
FDA (Devices) · 2024-09-18
- HighMedline Medical Convenience Kits with Plastic Syringes Recalled Due to Leaks and Breakage
FDA (Devices) · 2024-09-18