Serious riskFDA DeviceApr 1, 2026Class I

Merit Medical BioFlo DuraMax sheath recalled for splitting defect

Merit Medical Systems is recalling certain BioFlo DuraMax Catheters because the sheath introducer may not split as designed. This defect could lead to complications during medical procedures, including bleeding, blood clots, or difficulty removing the catheter.

From the FDA notice · Read the official notice ↗ · All Merit Medical recalls

What to do

Stop using affected BioFlo DuraMax Catheter units immediately
Check if your facility has recalled lot numbers by reviewing the product reference numbers and lot codes provided
Contact Merit Medical Systems for instructions on returns or replacement units
Report any adverse events or complications to FDA MedWatch

Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product: BioFlo DuraMax Catheter, REF: H965103028011/A, H965103028021/A, H965103028021/EU, H965103028031/A, H965103028031/EU, H965103028041/A, H965103028041/EU, H965103028051/A, H965103028051/EU, H965103028061/A, H965103028061/EU, H965103028070/A, H965103028070/EU, H965103028080/A, H965103028080/EU, H965103028090/A, H965103028090/EU, H965103028161/A, H965103028181/A, H965103028191/A, H965103028191/EU, H965103028201/A, H965103028211/A, H965103028220/A, H965103028230/A, H965103028240/A, H965103038181/A
Sold in: Nationwide
Made for: All ages (0 months and older)

This recall covers 5 products — see all of them.

Details

Units affected: 47,153
Illnesses reported: None reported
Manufactured in: 1600 W Merit Pkwy, South Jordan, UT, United States
Classification: Class I
Recall number: Z-1579-2026

In the FDA's words

Description: BioFlo DuraMax Catheter, REF: H965103028011/A, H965103028021/A, H965103028021/EU, H965103028031/A, H965103028031/EU, H965103028041/A, H965103028041/EU, H965103028051/A, H965103028051/EU, H965103028061/A, H965103028061/EU, H965103028070/A, H965103028070/EU, H965103028080/A, H965103028080/EU, H965103028090/A, H965103028090/EU, H965103028161/A, H965103028181/A, H965103028191/A, H965103028191/EU, H965103028201/A, H965103028211/A, H965103028220/A, H965103028230/A, H965103028240/A, H965103038181/A 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. 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 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 Affected quantity: 47,153
Hazard: 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.

5 products in this recall

Merit Medical catheters, sheath introducers recalled for splitting defect

Merit Medical is recalling five products, including CentrosFLO and DuraMax dialysis catheters and 16F dual valved splittable sheath introducers. The sheath introducer may not split as intended, which can cause bleeding, pieces left in the body, procedure delays, or blood clots. No injuries have been reported.

The agency lists each product separately. Check every one you might have.

CentrosFLO Hemodialysis Catheters, REF: CENFP15K/A, CENFP15K/B, CENFP17K/A, CENFP19K/A, CENFP23K/A, CENFP27K/A, CENFP31K/A, CENFT15K, CENFT15K/D, CENFT17K, C…
Z-1575-2026 · 35,591
ProGuide Chronic Dialysis Catheters, REF: DC01455550/C, DC21452419/C, DC21452419-NE5/C, DC21452823-NE5/C, DC21454035/C, DC21455550/C
Z-1576-2026 · 131
16F Dual Valved Splittable Sheath Introducer (bulk, non-sterile), REF: FCL-174-00/B
Z-1577-2026 · 368,264
DuraMax Chronic Hemodialysis Catheter, REF: H787103028015/A, H787103028025/A, H787103028031/A, H787103028035/A, H787103028041/A, H787103028045/A, H7871030280…
Z-1578-2026 · 21,591
BioFlo DuraMax Catheter, REF: H965103028011/A, H965103028021/A, H965103028021/EU, H965103028031/A, H965103028031/EU, H965103028041/A, H965103028041/EU, H9651… (this page)
Z-1579-2026 · 47,153