- Recalling firm
- Merit Medical Systems, Inc.
- 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.
- Affected products (lot / model / serial)
- REF:UDI-DI/Lot(Expiration): H965103028011/A:00884450793206/I3105589, I3115469, I3314948, I3343030; H965103028021/A:00884450793213/I2985084, I3235297, I3302100, I3343023; H965103028021/EU:00884450840733/I3254932; H965103028031/A:00884450786215/I2890967, I2909607, I2909610, I2909613, I2922255, I2928443, I2928445, I2973185, I2975817, I2979931, I2979932, I3010126, I3015730, I3015731, I3072562, I3108161, I3115487, I3120008, I3156395, I3161825, I3178917, I3202927, I3236144, I3236147, I3236157, I3236162, I3236164, I3368281; H965103028031/EU:00884450835326/I3219447, I3270828, I3288591; H965103028041/A:00884450786253/I2838431, I2910263, I2910264, I2910265, I2973186, I2975804, I2975805, I2979959, I2979960, I3015758, I3064923, I3064925, I3072563, I3108163, I3120003, I3120006, I3156399, I3165147, I3175748, I3178899, I3208677, I3236145, I3236148, I3236158, I3236163, I3236165, I3312321, I3315961, I3323271, I3347039; H965103028041/EU:00884450835333/I3217180, I3270829, I3302439; H965103028051/A:00884450793220/I2929337, I2997999, I3311219; H965103028051/EU:00884450840740/I3219448, I3270832, I3302440; H965103028061/A:00884450793237/I2920321, I2980492, I3154945, I3254911; H965103028061/EU:00884450835340/I3196140, I3270833, I3312332; H965103028070/A:00884450793244/I3015819, I3113237, I3170179, I3247943, I3288616; H965103028070/EU:00884450840757/I3255305, I3307483; H965103028080/A:00884450793251/I3002021, I306492, I3178919, I3302450, I3343031; H965103028080/EU:00884450840764/I3196137, I3302445, I3334625; H965103028090/A:00884450792353/I2920165, I3103138, I3178922, I3290565; H965103028090/EU:00884450840771/I3196135, I3302441, I3352493; H965103028161/A:00884450793268/I2914680, I2980457), I3098578; H965103028181/A:00884450793282/I2890978, I2902665, I2909617, I2909618, I2929338, I3076856, I3085067, I3098579, I3178915, I3254917, I3255301, I3283028; H965103028191/A:00884450793299/H2936911, I2870746, I2908636, I2909637, I2910257, I2920337, I2927199, I3144031, I3164176, I3219662, I3236146, I3288655, I3368110; H965103028191/EU:00884450835371/I3309111; H965103028201/A:00884450793305/I2973187, I3173621, I3178898), I3236149, I3288573; H965103028211/A:00884450793312/I2909764, I3144033, I3302435, I3343037; H965103028220/A:00884450793329/I2909788, I3394016; H965103028230/A:00884450793336/I2982337, I3044847, I3191920, I3288574, I3334623; H965103028240/A:00884450792360/I2929339, I3002035, I3049565, I3108165, I3254923, I3302451; H965103038181/A:00884450786314/I2890952, I2902661, I2902662
- Units affected
- 47,153
- Distribution pattern
- 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 location
- South Jordan, UT, United States
- Recall type
- Voluntary: Firm initiated
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-1579-2026
- Recall initiated
- February 13, 2026
- FDA classification date
- March 26, 2026
- FDA report date
- April 1, 2026
- FDA event ID
- 98464
- Last updated on HTM Vibe
- July 24, 2026