CentrosFLO Hemodialysis Catheters, REF: CENFP15K/A, CENFP17K/A, CENFP19K/A, CENFP23K/A, CENFP27K/...
FDA Device Recall #Z-1575-2026 — Class I — February 13, 2026
Recall Summary
| Recall Number | Z-1575-2026 |
| Classification | Class I — Serious risk |
| Date Initiated | February 13, 2026 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Merit Medical Systems, Inc. |
| Location | South Jordan, UT |
| Product Type | Devices |
| Quantity | 35,591 |
Product Description
CentrosFLO Hemodialysis Catheters, REF: CENFP15K/A, CENFP17K/A, CENFP19K/A, CENFP23K/A, CENFP27K/A, CENFP31K/A, CENFT15K, CENFT15K/D, CENFT17K, CENFT17K/A, CENFT17K/D, CENFT19K, CENFT19K/A, CENFT19K/B, CENFT19K/D, CENFT23K, CENFT23K/A, CENFT23K/B, CENFT23K/D, CENFT27K, CENFT27K/A, CENFT27K/B, CENFT27K/D, CENFT31K, CENFT31K/A, CENFT31K/B, CENFT31K/D
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, and procedure delay.
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
Lot / Code Information
REF:UDI-DI/Lot: CENFP15K/A:00884450199992/H3357122; CENFP15K/B: CENFP17K/A:00884450200001/H2643728, H2644554, H2755843, H2777866, H3357123; CENFP19K/A:00884450200018/H2415318, H2466455, H2466456, H2608337, H2632772, H2632921, H2643525, H2643729, H2658246, H2658395, H2663614, H2708827, H2777850, H2817064, H2817066, H2834183, H2834184, H2835774, H2875195, H2892153, H2900496, H2900649, H2918430, H2938756, H2982068, H2998532, H3019164, H3028009, H3089474, H3096774, H3101839, H3110067, H3123035, H3131873, H3139507, H3143969, H3152236, H3328470, H3332131, H3332133, H3357124, H3383280, H3398546; CENFP23K/A:00884450200025/H2368055, H2460265, H2543292, H2612929, H2622368, H2623456, H2631340, H2640771, H2663612, H2663613, H2719753, H2812164, H2817069,, H2834179, H2834181, H2847016, H2868174, H2880283, H2897527, H2900497, H2900550,, H2907334, H2911460, H2938761, H2978595, H2990699, H3004608, H3019163, H3049760,, H3049761 H3052479 H3071291 H3075039, H3089475, H3092914, H3096777, H3104588,, H3107507, H3120779, H3131874, H3143970, H3145117, H3191613, H3211721 H3316467,, H3328494, H3332218, H3332219, H3332220, H3351695;, CENFP27K/A:00884450200056/H2286892, H2480924, H2623453, H2643731, H2643732, H2653626, H2663616, H2777861, H2798003, H2833668, H2834185, H2880284, H2900619, H2907339, H2910719, H2911565, H2978601, H2986646, H2998508, H3004606, H3013812, H3019148, H3096779, H3110068, H3131879, H3143988, H3145119, H3156431, H3357125, H3383281; CENFT15K: H2845485,H2907340, H2911505, H2978606, H3004602; CENFT15K/D: H3071303, H3075046, H3116838; CENFP31K/A:00884450200063/H2623455, H2643737, H2663617, H3052480, H3071293, H3071294, H3110069, H3113265, H3143998, H3196708, H3328496, H3332421; CENFT17K:00884450276082/H2750962, H2755782, H2777600, H3034899, H3059017, H3059018, H3062346; CENFT17K/A:00884450295526/H2911456; CENFT17K/D:00884450820773/H3139508; CENFT19K:00884450276105/H2632775, H2658397, H2709212, H2817067, H2821275, H2835372, H2856854, H2864393S1, H2884659, H2900500, H2907322, H2907349, H2918517, H2933863, H2937909, H2937910, H2978622, H2999167, H3019145, H3034898, H3049764; CENFT19K/A:00884450295540/H2907422; CENFT19K/B:00884450725993/H2801414; CENFT19K/D:00884450820780/H3049766, H3049767, H3071304, H3075050, H3089478, H3126999, H3144001, H3152238, H3156433, H3162590, H3179819, H3196714, H3221338, H3233980, H3239914, H3253651, H3261220, H3283451, H3306069, H3350849, H3357127, H3357128, H3365884, H3372112, H3398547; CENFT23K:00884450276129/H2368107, H2657097, H2709213, H2719652, H2783586, H2812165, H2834187, H2834188, H2864382S1, H2870049, H2892155, H2898665, H2900501, H2907365, H2911451, H2911452, H2934395, H2971862, H2986161, H2986162, H2998549, H3007025, H3019139, H3028000; CENFT23K/A:00884450295564/H2709157, H2817068, H2911454, H2990794, H3013830, H3019136, H3034895; CENFT23K/B:00884450726006/H2801413; CENFT23K/D:00884450820797/H3049771, H3049772, H3071305, H3071306, H3145122, H3152240, H3170518, H3196713, H3201956, H3211729, H3221345, H3233987, H3239915, H3249275, H3275167, H3301761, H3306072, H3323733, H3332225, H3342600; CENFT27K:00884450276143/H2618709, H2642807, H2783590, H2817065, H2835374, H2884649, H2892156, H2900227, H2910433, H2937927, H2949972, H2971939, H3019133, H3027993, H3059051, H3062349, H3071308; CENFT27K/A:00884450295588/H2831335, H2847031, H2911463, H3019129; CENFT27K/B:00884450726013/H2801412; CENFT27K/D:00884450820803/H3049776, H3049777, H3080509, H3152241, H3179811, H3186110, H3191615, H3201954, H3206164, H3301764, H3323734, H3342755, H3372113, H3385315; CENFT31K:00884450276167/H2821396, H2884650, H2900615, H2911536, H2933865, H2971861, H3003224, H3059059, H3059060, H3089477, H3101838; CENFT31K/A:00884450295601/H2938653, H3013843; CENFT31K/B:00884450726020/H2811536; CENFT31K/D:00884450820810/H3071085, H3071309, H3082414, H3144317, H3163092, H3179823, H3191620, H3206153, H3239916, H3249277, H3275168, H3283445, H3306075, H3323741
Other Recalls from Merit Medical Systems, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1577-2026 | Class I | 16F Dual Valved Splittable Sheath Introducer (b... | Feb 13, 2026 |
| Z-1579-2026 | Class I | BioFlo DuraMax Catheter, REF: H965103028011/A, ... | Feb 13, 2026 |
| Z-1576-2026 | Class I | ProGuide Chronic Dialysis Catheters, REF: DC014... | Feb 13, 2026 |
| Z-1578-2026 | Class I | DuraMax Chronic Hemodialysis Catheter, REF: H78... | Feb 13, 2026 |
| Z-1125-2026 | Class II | Merit Medical , Custom Waste Management Kit Vas... | Dec 4, 2025 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.