Recall Z-1125-2026— Merit Medical Systems, Inc.

Class II · Ongoing

Class II FDA medical device recall by Merit Medical Systems, Inc., initiated 2025-12-04. FDA's recall record names no specific 510(k) clearance for this event. Product: Merit Medical , Custom Waste Management Kit Vascular Tray REF: K10T-05261. Reason: Inflation device handle may detach from the syringe during procedure..

Recalling firm
Merit Medical Systems, Inc.
Classification
Class II
Status
Ongoing
Initiated
2025-12-04
Firm location
South Jordan, UT, United States

Product description

Merit Medical , Custom Waste Management Kit Vascular Tray REF: K10T-05261

Reason for recall

Inflation device handle may detach from the syringe during procedure.

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