Merit Medical Systems, Inc.: Medical Device Recall in 2024 - (Recall #: Z-2566-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K11 (Custom Pressure Monitoring Kit), REF: K11-00382C To support fluid administration into the body and physiological pressure monitoring. To support various vascular or cardiac diagnostic and interventional procedures.

Product Classification:

Class II

Date Initiated: June 11, 2024

Date Posted: August 21, 2024

Recall Number: Z-2566-2024

Event ID: 94797

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.

Status: Ongoing

Product Quantity: 69 kits

Code Information:

Catalog Number/UDI-DI code/Lot Numbers: K11-00382C 00884450158425 H2379628 H2531736 H2536619 H2813488 H2881603 H2916468

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.

Voluntary or Mandated:

Voluntary: Firm initiated