Z-1577-2026Class I

Merit Medical Systems, Inc.

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm

Product type

Device

Status

Ongoing

Report date

2026-04-01

Distribution

Worldwide distribution: US (nationwide) to states of: TX, LA, OR, NM, MI, FL, CO, CA, GA, NC, AK, NY, PA, WI, NJ, VA, AZ, IN, KY, MO, DE, SC, MT, NE, WV, OH, MA, MN, CT, MD, KS, WA, TN, ID, UT, DC, MS, IL, OK, AL, RI, AR, NV and OUS (International) to countries of : Canada, Spain, United Arab Emirates, Brazil, Jordan, Iraq, France, Indonesia, Malaysia, Thailand, Slovakia, Colombia, Saudi Arabia, Belize, Hong Kong, Mexico, Austria, Belgium, Chile, Germany, Sweden, Ireland, Poland, Latvia, Italy, South Africa, Switzerland, Bulgaria, Peru, Argentina, Qatar, Greece, Georgia, United Kingdom, Brunei Darussalam, Ecuador, Panama, Netherlands, Venezuela, Bolivarian Republic of, Costa Rica, Viet Nam, Cayman Islands, Iran, Islamic Republic of, Australia, Nicaragua, Dominican Republic, Bolivia, Plurinational State of, El Salvador, Guatemala, Honduras, Japan

Firm state

Product quantity

368,264

Initiated by

Voluntary: Firm initiated

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.

Product description

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

Code / lot info

REF:UDI-DI/Lot: FCL-174-00/B:00884450522196/I2362705, I2370091, I2370711, I2370712, I2377840, I2377841, I2391548, I2397290, I2415120, I2417400, I2417401, I2417402, I2428656, I2428657, I2428658, I2428659, I2469204, I2469205, I2469206, I2469207, I2473119, I2485668, I2485669, I2485670, I2485671, I2485672, I2485673, I2485674, I2485675, I2496785, I2496787, I2496790, I2516610, I2516611, I2516612, I2516613, I2516614, I2516615, I2539710, I2539711, I2539713, I2539714, I2539715, I2539717, I2561078, I2561079, I2561081, I2561082, I2573969, I2606642, I2606643, I2606644, I2606645, I2619459, I2621646, I2621647, I2621648, I2621649, I2621650, I2621651, I2621652, I2621653, I2642738, I2642739, I2642740, I2644031, I2644032, I2644033, I2644034, I2644036, I2661872, I2661873, I2661874, I2661875, I2661876, I2661877, I2708121, I2708122, I2708123, I2708124, I2720071, I2720074, I2720075, I2720076, I2720077, I2720078, I2720079, I2729938, I2729939, I2729940, I2729941, I2729942, I2729943, I2729944, I2729945, I2759253, I2759254, I2759255, I2759256, I2759257, I2759258, I2759260, I2759261, I2759268, I2759269, I2781492, I2781493, I2781494, I2781495, I2781496, I2781497, I2781498, I2781499, I2788883, I2788884, I2788885, I2788886, I2788887, I2788888, I2788889, I2788890, I2788891, I2788892, I2810292, I2810293, I2810294, I2810296, I2810297, I2841474, I2841475, I2849305, I2849306, I2854355, I2854356, I2854357, I2860217, I2860218, I2861568, I2861569, I2871785, I2871786, I2871787, I2883689, I2883691, I2890983, I2904247, I2904250, I2927630, I2927631, I2942563, I2942564, I2942565, I2942566, I2942567, I2942568, I2942569, I2942570, I2942571, I2942667, I2942669, I2988895, I2988896, I2988897, I3013245, I3013246, I3075993, I3075994, I3075995, I3075996, I3075997, I3083308, I3083309, I3083310, I3083312, I3083314, I3083317, I3098214, I3098256, I3127468, I3138237, I3138238, I3138239, I3138240, I3138241, I3138242, I3159773, I3159774, I3159776, I3159777, I3186218, I3257331

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →