{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-10", "results": { "skip": 0, "limit": 1, "total": 5 } }, "results": [ { "cfres_id": "218828", "product_res_number": "Z-1575-2026", "event_date_initiated": "2026-02-13", "event_date_posted": "2026-03-26", "recall_status": "Open, Classified", "res_event_number": "98464", "product_code": "MSD", "k_numbers": [ "K151967" ], "product_description": "CentrosFLO Hemodialysis Catheters, REF: CENFP15K/A, CENFP15K/B, 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", "code_info": "REF:UDI-DI/Lot:\nCENFP15K/A:00884450199992/H3357122;\nCENFP15K/B:00884450725917/H2797565;\nCENFP17K/A:00884450200001/H2643728, H2644554, H2755843, H2777866, H3357123;\nCENFP19K/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;\nCENFP23K/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; \nCENFT15K:00884450276068/H2845485,H2907340, H2911505, H2978606, H3004602;\nCENFT15K/D:00884450820766/ H3071303, H3075046, H3116838;\nCENFP31K/A:00884450200063/H2623455, H2643737, H2663617, H3052480, H3071293, H3071294, H3110069, H3113265, H3143998, H3196708, H3328496, H3332421;\nCENFT17K:00884450276082/H2750962, H2755782, H2777600, H3034899, H3059017, H3059018, H3062346;\nCENFT17K/A:00884450295526/H2911456;\nCENFT17K/D:00884450820773/H3139508;\nCENFT19K:00884450276105/H2632775, H2658397, H2709212, H2817067, H2821275, H2835372, H2856854, H2864393S1, H2884659, H2900500, H2907322, H2907349, H2918517, H2933863, H2937909, H2937910, H2978622, H2999167, H3019145, H3034898, H3049764;\nCENFT19K/A:00884450295540/H2907422;\nCENFT19K/B:00884450725993/H2801414;\nCENFT19K/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;\nCENFT23K: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;\nCENFT23K/A:00884450295564/H2709157, H2817068, H2911454, H2990794, H3013830, H3019136, H3034895;\nCENFT23K/B:00884450726006/H2801413;\nCENFT23K/D:00884450820797/H3049771, H3049772, H3071305, H3071306, H3145122, H3152240, H3170518, H3196713, H3201956, H3211729, H3221345, H3233987, H3239915, H3249275, H3275167, H3301761, H3306072, H3323733, H3332225, H3342600; \nCENFT27K:00884450276143/H2618709, H2642807, H2783590, H2817065, H2835374, H2884649, H2892156, H2900227, H2910433, H2937927, H2949972, H2971939, H3019133, H3027993, H3059051, H3062349, H3071308;\nCENFT27K/A:00884450295588/H2831335, H2847031, H2911463, H3019129;\nCENFT27K/B:00884450726013/H2801412;\nCENFT27K/D:00884450820803/H3049776, H3049777, H3080509, H3152241, H3179811, H3186110, H3191615, H3201954, H3206164, H3301764, H3323734, H3342755, H3372113, H3385315;\nCENFT31K:00884450276167/H2821396, H2884650, H2900615, H2911536, H2933865, H2971861, H3003224, H3059059, H3059060, H3089477, H3101838;\nCENFT31K/A:00884450295601/H2938653, H3013843;\nCENFT31K/B:00884450726020/H2811536;\nCENFT31K/D:00884450820810/H3071085, H3071309, H3082414, H3144317, H3163092, H3179823, H3191620, H3206153, H3239916, H3249277, H3275168, H3283445, H3306075, H3323741", "firm_fei_number": "1721504", "recalling_firm": "Merit Medical Systems, Inc.", "address_1": "1600 W Merit Pkwy", "city": "South Jordan", "state": "UT", "postal_code": "84095-2416", "additional_info_contact": "801-253-1600", "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.", "root_cause_description": "Process control", "action": "On 2/13/2026, recall notices were mailed and emailed to customers who were asked to do the following:\n\nA picture of the 16F Dual-Valved Splittable Sheath Introducer is attached to help you identify the product. Place this notice and the picture on or near the affected product in your inventory (if applicable).\n\nDiscontinue the use of the 16F Dual-Valved Splittable Sheath Introducer and destroy the sheath introducer at the point of use.\n\nEnsure that applicable personnel within your organization are made aware of this field action.\n\nIf the product has been further distributed to other facilities, institutions, or manufacturers, ensure this notice is immediately shared with them and note the quantity distributed on the customer response form.\n\nComplete and return the customer response form via email to response@merit.com\n\nIf you have any questions concerning this communication, contact the firm's Customer Service via email at RESPONSE@merit.com or via phone at +1 800 356 3748, Hours: 6 am to 6 pm MST, Mon-Fri.\n\nOn 4/2/2026, revised notices were mailed to customers that included stickers to be placed on affected devices to ensure awareness of the recall.", "product_quantity": "35,591", "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", "openfda": { "k_number": [ "K092205", "K020315", "K063431", "K072499", "K002901", "K111817", "K113487", "K073092", "K062901", "K111117", "K190527", "K021759", "K022678", "K041559", "K092597", "K040260", "K040992", "K033294", "K981365", "K040509", "K203767", "K012365", "K021212", "K002902", "K131260", "K043272", "K030277", "K033676", "K043292", "K040736", "K011916", "K141051", "K030983", "K971925", "K041006", "K063441", "K982333", "K202150", "K090101", "K130889", "K133796", "K151967", "K062671", "K111372", "K042672", "K140884", "K080400", "K102238", "K040078", "K091760", "K042016", "K123943", "K071202", "K202176", "K051280", "K022905", "K102043", "K173805", "K060155", "K994105", "K010567", "K030502", "K010306", "K040492", "K051748", "K040666", "K141363", "K203575", "K121933", "K982326", "K110936", "K100169", "K130851", "K060972", "K241581", "K211410", "K012562", "K030020", "K032712", "K123196", "K972207", "K173667", "K042858", "K171618", "K182443", "K023023", "K981994", "K053589", "K073093", "K143567", "K210461", "K020936", "K140492", "K111900", "K070572", "K012948", "K130192", "K090528", "K013160", "K090148", "K003207", "K022000", "K001633", "K091506", "K121848", "K111651", "K040402", "K040328", "K161026", "K020465", "K010399", "K981125", "K022662", "K041914", "K060288", "K171571", "K051584", "K040318", "K071422", "K131814", "K101843", "K023847", "K032061", "K200627" ], "device_name": "Catheter, Hemodialysis, Implanted", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.5540", "device_class": "2", "registration_number": [ "2020394", "3007137787", "1722746", "3010882065", "1018233", "3012050423", "3005987240", "2527072", "2183744", "9617592", "3035111606", "3009211636", "2030598", "3002807314", "3015225571", "1721504", "3003915875", "3006950086", "3012536737", "9610849", "3015309643", "1319639", "3010041511", "3014461810", "3011642792", "1833566", "3017210488", "1724474", "2528981", "3011534620", "2518902", "3030574705", "1721676", "3013557562", "1644312", "3004111573", "3008998256", "3008110587", "3015859709", "3004134316", "3011137372", "3007544634", "3033589330", "3006082230", "1061124", "2030624", "3006942602", "1282497", "9680794", "3016727301", "3006260740", "1625425", "3013750125", "9611665", "3015453963" ], "fei_number": [ "1000512168", "2020394", "3007137787", "1000138054", "1018233", "3012050423", "3005987240", "2527072", "2183744", "3035111606", "3003094851", "3009211636", "3002807314", "3000206435", "3015225571", "1721504", "3003915875", "3006950086", "3012536737", "3015309643", "3010041511", "3014461810", "3011642792", "1000306216", "3002807391", "3017210488", "1000518731", "2528981", "3011534620", "3006097687", "3030574705", "2518902", "1721676", "3013557562", "3002807095", "3004111573", "3008998256", "3008110587", "3015859709", "3004134316", "1000117748", "3007544634", "3033589330", "3002468371", "3006082230", "3006942602", "1282497", "1000115408", "3016727301", "3006260740", "3003737899", "1625425", "3005747797", "3013750125", "3015453963" ] } } ] }