Recall Z-2293-2025— Merit Medical Systems, Inc.

Name: FDA recall Z-2293-2025
Creator: U.S. Food and Drug Administration
Published: 2025-06-05

Class II · Ongoing

Class II FDA medical device recall by Merit Medical Systems, Inc., initiated 2025-06-05. It names one FDA 510(k) clearance: K883718. Product: High Pressure Tubing: REF: 502211002, HP9720E/C, HP9721E/C. Reason: High pressure tubing may relax over time causing it to partially separate from the connector resulting in a void that can trap air in the line. Use of the affected product may result in the trapped air being introduced into the patient..

Recalling firm: Merit Medical Systems, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2025-06-05
Firm location: South Jordan, UT, United States

510(k) clearances named in this recall

1 on FDA's record

K883718 — MERIT HI-FLEX(TM)Merit Medical Systems, Inc.·cleared 1989-01-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

High Pressure Tubing: REF: 502211002, HP9720E/C, HP9721E/C

Reason for recall

High pressure tubing may relax over time causing it to partially separate from the connector resulting in a void that can trap air in the line. Use of the affected product may result in the trapped air being introduced into the patient.

Data sourced from openFDA. This site is unofficial and independent of the FDA.