Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co...

FDA Device Recall #Z-2558-2024 — Class II — June 11, 2024

Recall Summary

Recall Number Z-2558-2024
Classification Class II — Moderate risk
Date Initiated June 11, 2024
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Merit Medical Systems, Inc.
Location South Jordan, UT
Product Type Devices
Quantity 11837 kits

Product Description

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Custom Procedure Kit (Angiography/angioplasty kit), REF: K12T-10773 K12T-09284D K12T-10621 K12T-10800 K12T-12491 To support various vascular or cardiac diagnostic and interventional procedures.

Reason for Recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Distribution Pattern

U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY.

Lot / Code Information

Catalog Number/UDI-DI code/Lot Numbers: K12T-10773 00884450426388 T2800379 T2824129 T2849013 T2857243 K12T-09284D 00884450602102 T2209872 T2220946 T2359067 T2364198 T2508160 T2674429 T2794927 T2800155 K12T-10621 00884450409435 T2308653 T2344516 T2411888 T2428905 T2429939 T2448507 T2452908 T2473123 T2498967 T2531706 T2597113 T2611405 T2629759 T2653268 T2685014 T2691082 T2715028 T2744136 T2776727 T2846077 T2873111 K12T-10800 00884450421093 T2280633 T2407018 T2503204 T2643484 T2680463 T2705035 T2885158 K12T-12491 00884450820605 T2905902

Other Recalls from Merit Medical Systems, Inc.

Recall # Classification Product Date
Z-1578-2026 Class I DuraMax Chronic Hemodialysis Catheter, REF: H78... Feb 13, 2026
Z-1576-2026 Class I ProGuide Chronic Dialysis Catheters, REF: DC014... Feb 13, 2026
Z-1577-2026 Class I 16F Dual Valved Splittable Sheath Introducer (b... Feb 13, 2026
Z-1575-2026 Class I CentrosFLO Hemodialysis Catheters, REF: CENFP15... Feb 13, 2026
Z-1579-2026 Class I BioFlo DuraMax Catheter, REF: H965103028011/A, ... Feb 13, 2026

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.