{ "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": "2026-09-17", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "215547", "product_res_number": "Z-2553-2025", "event_date_initiated": "2025-07-25", "event_date_posted": "2025-09-11", "recall_status": "Open, Classified", "res_event_number": "97420", "product_code": "DTL", "product_description": "10Fore Hemostasis Valve\nCatalog Number / UDI-DI code:\nMAPTEN4 / 00884450821305\nMAPTEN42 / 00884450832509\nMAPTEN452 / 00884450821329\n\nThe 10Fore Hemostasis Valve is intended to maintain hemostasis during the\nintroduction/withdrawal and use of diagnostic and interventional devices.", "code_info": "Catalog Number / UDI-DI code:\nMAPTEN4 / 00884450821305\nLot Numbers:\nH3098831\nH3111155\nH3152503\nH3155611\nH3186901\n\nMAPTEN42 / 00884450832509\nLot Numbers:\nH3076189\nH3111156\nH3152504\nH3155614\nH3173674\n\nMAPTEN452 / 00884450821329\nLot Number:\nH3111162", "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": "Ms. Hannah Gay\n801-432-2786", "reason_for_recall": "Due to a manufacturing issue involving the silicone quad ring where the ring is deformed or otherwise damaged and may cause a foreign body in the fluid pathway.", "root_cause_description": "Employee error", "action": "On 07/23/2025, the firm emailed an \"URGENT MEDICAL DEVICE RECALL NOTICE\" to customers informing them that due to a manufacturing defect. Specifically, the o-ring between the y-body and the rotator may be damaged during assembly and a portion of the o-ring may remain loose or detach. Use of the affected product may result in a foreign body in the fluid path.\n\nCustomer are instructed to:\nImmediately stop using or distributing the affected lots and return to Merit.\n1. Please immediately determine if any of the devices identified in the attached Customer Response Form (CRF) are within your facility, quarantine them, and discontinue use and distribution.\n2. Ensure that applicable personnel within your organization are made aware of this field action.\n3. If the product has been further distributed to other facilities, institutions, or manufacturers, please ensure this notice is immediately shared with them and note the quantity distributed on the CRF.\nAdditional distribution details may be required by health authorities.\n4. Please fill out, scan and email the completed Customer Response Form to Customer Service at response@merit.com within 10 business days. All affected product shipped to you must be accounted for on the CRF.\n5. Please immediately return all affected lots in your possession to Merit, per the instructions in the attached CRF.\n\nAny questions concerning this communication, contact your Merit Sales Representative or Merit 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.", "product_quantity": "447", "distribution_pattern": "Worldwide - U.S. Nationwide distribution in the states of CA, FL, LA, MT, NY, SD, and WI. The countries of Canada and Korea", "openfda": { "k_number": [ "K092563", "K031398", "K862451", "K873488", "K963749", "K854960", "K113667", "K854261", "K900652", "K790563", "K863661", "K925419", "K900994", "K780271", "K140475", "K884200", "K952531", "K993057", "K895795", "K033328", "K122811", "K772299", "K801405", "K790564", "K021282", "K080472", "K030077", "K801402", "K911884", "K991102", "K003604", "K100319", "K790804", "K820864", "K933084", "K072745", "K852118", "K092711", "K831260", "K813141", "K897196", "K910845", "K860291", "K022918", "K912709", "K853586", "K780056", "K992906", "K961181", "K922840", "K152528", "K800880", "K120069", "K122301", "K041697", "K123448", "K101113", "K113132", "K801200", "K893683", "K031688", "K934123", "K914987", "K792113", "K760843", "K801399", "K880831", "K897137", "K791498", "K042060", "K832625", "K953564", "K861783", "K945461", "K892368", "K853749", "K872161", "K073260", "K853099", "K883956", "K897197", "K791914", "K801404", "K913161", "K873971", "K890580", "K863177", "K831261", "K782095", "K870325", "K942391", "K072556", "K791797", "K801828", "K945931", "K891572", "K791107", "K060759", "K863402", "K913363", "K093992", "K882717", "K113845", "K833322", "K951089", "K955554", "K091634", "K884408", "K870073", "K113148", "K842829", "K812408", "K912969", "K073620", "K040498", "K073474", "K820297", "K143429", "K851465", "K852086", "K854397", "K915301", "K890676", "K812407", "K840797", "K954284", "K052381", "K052459", "K131124", "K781579", "K802544", "K972654", "K902741", "K833644", "K840603", "K853950", "K892377" ], "registration_number": [ "3018312328", "3015910259", "1625519", "1000533027", "1721504", "2182208", "1820334", "1625425", "3007836437", "1423395", "3004122598", "3008853977", "1721676", "3003955307", "3004198398", "3022815697", "2024168", "9616088", "3013298431", "3034544377", "3045058049", "3027815", "1423537", "3016950436", "3031282706", "1048735", "9612152", "3012776242", "9680794", "3036802499", "2521402", "1220452", "2939561", "1000112137", "3045816902", "9617601", "1718873", "2320762", "3000247873", "3002808467", "3019807891", "3010273872", "9616662", "2124215", "3006542380", "3006942524", "9681260", "9614279", "1061124", "3010872792", "3033589330", "3004859241", "1054241", "2032677", "3044778332", "3005273623", "1724474", "3014499739", "3004194523", "3011237770", "3008361782", "3006210673", "3008403546", "3004111573", "3012964172", "1319639", "1422634", "3004091615", "3015309643", "3010188783", "3031571797", "1055236", "3009605245", "3007289408", "3010291427", "3003932293", "3010141307", "2024024", "1043214", "3027637845", "3008002401", "1643817", "3015276780", "2134812", "3031233007", "1417592", "3007361214", "1649395", "8020785", "3004519921", "3045816907", "1124841", "2529846", "3006181312", "3013557562", "3007138831", "1644312", "9616684", "3018167761", "3012050423", "3004605321", "3008261722", "1450662", "3011564431", "2025816", "3007830707", "3003898360", "3002808466", "3015173212", "1037885", "3004961578", "2027062", "3015225571", "9616567", "1123137", "2011171", "3011642792", "3015453963", "3009380063", "2184009", "3009291251", "3007603855", "9610825", "1060680", "1000121056", "3002807314", "3006425876", "2523676", "1928237", "3005595283", "3011137372", "3010432890", "3017987980", "3006950086", "3017636737", "3007835716", "3005012805", "3005941719", "2648727", "3006891665", "3011826338", "1018470", "2030624", "3012536737", "1718850", "2029275", "3038846851", "3006223010" ], "fei_number": [ "3018312328", "1000138054", "1000117748", "3015910259", "3002827704", "1625519", "1000533027", "1721504", "2182208", "3005846326", "1820334", "1625425", "3007836437", "1000116158", "3004122598", "3008853977", "1721676", "3003955307", "3004198398", "3022815697", "2024168", "3004635528", "1000306431", "3013298431", "1000512168", "3034544377", "3045058049", "3016950436", "3031282706", "3001236905", "1048735", "3012776242", "3002806469", "3036802499", "2521402", "1220452", "1000112137", "3045816902", "1718873", "3000247873", "3002808467", "3019807891", "3010273872", "3003945344", "3002913962", "2124215", "3006542380", "3006942524", "3000335778", "3005747797", "3000718472", "3010872792", "3033589330", "3004859241", "3002963732", "1000123180", "3044778332", "3005273623", "3014499739", "3004194523", "1000112968", "3011237770", "3008361782", "3006210673", "3008403546", "3003094851", "3004111573", "3012964172", "1000514656", "3004091615", "3015309643", "3010188783", "3002807111", "3031571797", "3009605245", "3000206435", "3007289408", "3010291427", "1000208624", "3003932293", "3000204839", "3010141307", "3000717925", "2024024", "1043214", "3027637845", "3008002401", "3002806565", "3015276780", "1643817", "3031233007", "1417592", "3007361214", "3045816907", "3006181312", "3013557562", "3007138831", "3003767881", "3018167761", "3012050423", "3004605321", "3008261722", "3003737899", "1450662", "3011564431", "2025816", "1000127185", "3007830707", "3003898360", "3002808466", "3015173212", "1037885", "3004961578", "2027062", "1000136191", "3015225571", "2011171", "3011642792", "3015453963", "3009380063", "3002534070", "3009291251", "3007603855", "1000121056", "3002807314", "3006425876", "2523676", "1928237", "1000112877", "3005595283", "3010432890", "3017987980", "3006950086", "3017636737", "3007835716", "3005012805", "3003040625", "2648727", "3006891665", "3011826338", "1018470", "3012536737", "1718850", "3002902735", "3038846851", "3002806901", "3006223010" ], "device_name": "Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.4290", "device_class": "2" } } ] }