Recall Z-1577-2026— Merit Medical Systems, Inc.

Name: FDA recall Z-1577-2026
Creator: U.S. Food and Drug Administration
Published: 2026-02-13

Class I · Ongoing

Class I FDA medical device recall by Merit Medical Systems, Inc., initiated 2026-02-13. It names one FDA 510(k) clearance: K043438. Product: 16F Dual Valved Splittable Sheath Introducer (bulk, non-sterile), REF: FCL-174-00/B. Reason: 16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thrombosis, impaired catheter function, loss of vessel for future vascular access..

Recalling firm: Merit Medical Systems, Inc.
Classification: Class I
Status: Ongoing
Initiated: 2026-02-13
Firm location: South Jordan, UT, United States

510(k) clearances named in this recall

1 on FDA's record

K043438 — LARGE BORE SPLITTABLE INTRODUCER KITThomas Medical Products, Inc.·cleared 2005-02-15

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

16F Dual Valved Splittable Sheath Introducer (bulk, non-sterile), REF: FCL-174-00/B

Reason for recall

16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thrombosis, impaired catheter function, loss of vessel for future vascular access.

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