{ "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": "215612", "product_res_number": "Z-0533-2026", "event_date_initiated": "2025-08-04", "event_date_posted": "2025-11-17", "recall_status": "Open, Classified", "res_event_number": "97446", "product_code": "DTL", "product_description": "PhD Hemostasis Valve, REF: IN4802/K, IN4802/T, IN4918/A, IN7802/C, IN8802/C, IN9802, IN9802/A, K05-02166B, K05T-02138A, K12T-10798A, MAP800/B, MAP800/T, MAP801/B, MAP802/B, MAP802/CNB, MAP802/T, MAP804/B, MAP852/B, SKY1802.", "code_info": "REF/UDI-DI/Lot(Expiration):\nIN4802/K/00884450638385/I3138883(20-FEB-2028), I3150031(27-FEB-2028), I3161209(10-MAR-2028), I3161210(08-APR-2028), I3161211(17-MAR-2028), I3172451(30-NOV-2026);\n\nIN4802/T/00884450860113/I3135188(30-NOV-2026, I3170171(10-MAR-2028;\n\nIN4918/A/00884450638521/I3146050(20-FEB-2028), I3200779(19-MAY-2028);\n\nIN7802/C/00884450498743/H3143753(30-NOV-2026), H3162387(14-MAR-2028), H3183068(31-MAR-2028), H3189446(29-FEB-2028), H3213617(31-MAY-2028);\n\nIN8802/C/00884450621417/H3141570(02-FEB-2028), H3143769(03-FEB-2028), H3143770(31-DEC-2026), H3143771(03-FEB-2028), H3143772(03-FEB-2028), H3149478(17-FEB-2028), H3149480(31-DEC-2026), H3149483(31-DEC-2026), H3155549(24-FEB-2028), H3162422(14-MAR-2028), H3162627(14-MAR-2028), H3168247(07-MAR-2028), H3183054(31-DEC-2026), H3200495(26-APR-2028), H3219087(10-JUN-2028), H3241812(31-MAY-2028);\n\nIN9802/00884450413463/H3141573(21-MAR-2028), H3183200(28-MAR-2028);\n \nIN9802/A/00884450021347/H3200469(26-APR-2028), H3210336(30-NOV-2026);\n\nK05-02166B/00884450499597/T3192808(24-FEB-2027), T3198985(11-AUG-2027), T3201276(27-FEB-2027), T3217490(02-SEP-2027);\n\nK05T-02138A/ 00884450095607\nT3232335(15-AUG-2027);\n\nK12T-10798A/00884450544372/T3163727(21-MAY-2027), T3217266(20-FEB-2026);\n \nMAP800/B/ 00884450746714/I3124454(07-JAN-2028), I3174736(10-MAR-2028), I3186951(24-MAR-2028), I3191334(01-APR-2028), I3206933(21-APR-2028), I3209939(29-APR-2028), I3219784(12-MAY-2028), I3219792(12-MAY-2028), I3234557(19-MAY-2028), I3234558(26-MAY-2028);\n\nMAP800/T/00884450003985/I3162929(10-MAR-2028), I3162931(17-MAR-2028), I3186954(17-MAR-2028), I3186961(15-APR-2028);\n\nMAP801/B/00884450746721/I3146099\t(24-MAR-2028), I3186946(21-APR-2028), I3209937(31-DEC-2026);\n\nMAP802/B/00884450746745/I3118322(21-JAN-2028), I311832407-JAN-2028), I3129725(06-FEB-2028), I3129726(06-FEB-2028), I3150110(20-FEB-2028), I3150111(20-FEB-2028), I3162940(27-FEB-2028), I3162942(03-MAR-2028), I3174729(03-MAR-2028), I3174730(17-MAR-2028), I3192937(15-APR-2028), I3200996(15-APR-2028), I3209935(29-APR-2028), I3215925(29-APR-2028), I3215926(30-APR-2028), I3215928(05-MAY-2028), I3219783(30-APR-2028), I3219785(19-MAY-2028), I3219786(19-MAY-2028), I3230013(26-MAY-2028);\n\nMAP802/CNB/00884450746752/I3174740(08-APR-2028);\n \nMAP802/T/00884450860939/I3162943(17-MAR-2028), I3192650(08-APR-2028), I3192654(22-APR-2028);\n\nMAP804/B/00884450746783/I3146101(31-OCT-2027), I3161426(31-DEC-2027);\n\nMAP852/B/00884450746820/I3187883(28-FEB-2028);\n\nSKY1802/00884450822500/H3079946(20-OCT-2027), H3141576(21-MAR-2028), H3141577(21-MAR-2028), H3149507(28-MAR-2028), H3149508(28-MAR-2028), H3155575(21-MAR-2028), H3155576(21-MAR-2028), H3155577(21-MAR-2028), H3155578(14-MAR-2028), H3168264(29-FEB-2028), H3168265(29-FEB-2028), H3182996(28-MAR-2028), H3183206(31-MAR-2028), H3183207(31-MAR-2027), H3189428(12-APR-2028), H3189451(12-APR-2028), H3200416(19-APR-2028), H3200475(19-APR-2028), H3219111(30-NOV-2026)", "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": "Fred P. Lampropoulos \n801-253-1600", "reason_for_recall": "Hemostasis valve has a manufacturing defect and when used the valve cap may remain depressed, leading to potential leakage, which may result in procedure inconvenience and/or hemorrhage.", "root_cause_description": "Process change control", "action": "On 8/4/2025, recall notices were mailed and emailed to customers who were asked to do the following:\n\n1) Identify affected devices, quarantine, 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 customer response form. Additional distribution details may be required by health authorities.\n4) Complete and return the customer response form via email to RESPONSE@merit.com \n5. Return all affected lots to Merit, per the instructions in the customer response form.\n\nIf you have any questions concerning this communication, please contact the firm at RESPONSE@merit.com or via phone at +1 800 356 3748, Hours: 6 am to 6 pm MST, Mon-Fri.", "product_quantity": "217,141", "distribution_pattern": "US: PA, AZ, LA, CO, FL, NC, SC, OH, AK, IL, IA, MN, TX, WI, AR, NY, CA, KS, NJ, MI, VA, KY, AL, MT, NE, MA, MO, TN, CT, MD, WA, DC, ME, OR, NH, IN, GA, UT, OK, HI, RI, ID, NM, MS, WV, SD, DE, NV, ND.\n\nOUS: United Arab Emirates, Australia, Italy, Spain, Sweden, Norway, Germany, France, Belgium, Netherlands, Thailand, New Zealand, Mexico, Puerto Rico, Canada, Korea, Republic of, South Africa, Qatar, Iceland, United Kingdom, Viet Nam, Slovakia, Guam, Oman, Portugal, Madagascar, Saudi Arabia, Finland, Cyprus, Switzerland, Taiwan, China, Japan", "openfda": { "k_number": [ "K092563", "K031398", "K862451", "K873488", "K963749", "K854960", "K113667", "K854261", "K900652", 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"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", 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"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" } } ] }