{ "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": 1 } }, "results": [ { "cfres_id": "218319", "product_res_number": "Z-1492-2026", "event_date_initiated": "2025-12-18", "event_date_posted": "2026-03-04", "recall_status": "Open, Classified", "res_event_number": "98338", "product_code": "DSY", "k_numbers": [ "K241070", "K241550" ], "product_description": "Gelsoft Plus, REF: 635024PE, 631514PE, 631222PE, 633008PE, 633010PE, 633007PE, 636010PE, 632522PE, 633012PE, 635018PE, 631516PE, 636016PE, 631220PE, 631608PE, 631206PE, 631407P50E, 631508PE, 636008PE, 636006PE, 632518PE, 634008PE, 634006PE, 631218PE, 632211PE, 634007PE, 633006PE, 631506PE, 632524PE, 636007PE, 631512PE, 636012PE, 636014PE, 632211P50E, 633016PE, 631407PE, 631809PE, 632010PE, 631608P50E, 632520PE, 632412PE, 631510PE, 635022PE, 631224PE, 632412P50E, 631507PE, 633014PE, 632010P50E, 635020PE, 631809P50E.\n\n\nGelweave, REF: 736038E, 736036E, 736034E, 736032ST/10DE, 736032E, 736030ST/10DE, 736030E, 736028ST/10DE, 736028E, 736026ST/10DE, 736026E, 736024ST/10DE, 736024E, 736022ST/10DE, 736022E, 736020E, 736018E, 736016E, 736014E, 736012E, 736010E, 736008E, 736006E, 735034ST/8AE, 735034/8RME, 735034/10SEE, 735034/10RME, 735032STE, 735032ST/8AE, 735032/8SE, 735032/8RME, 735032/10SEE, 735032/10RME, 735030STE, 735030ST/8AE, 735030/8SE, 735030/8RME, 735030/10SEE, 735030/10RME, 735028STE, 735028ST/8AE, 735028E, 735028/8SE, 735028/8RME, 735028/10RME, 735026STE, 735026ST/8AE, 735026E, 735026/8SE, 735026/8RME, 735026/10RME, 735024STE, 735024ST/8AE, 735024E, 735024/8SE, 735024/8RME, 735024/10SEE, 735024/10RME, 735022STE, 735022E, 735022/8SE, 735022/8RME, 735020E, 735020/8RME, 735018E, 734038E, 734036E, 734034E, 734034CX4RMSE, 734034/8E, 734034/10E, 734032E, 734032CX4RMSE, 734032/8E, 734032/10E, 734030E, 734030CX4RMSE, 734030/8E, 734030/10E, 734028CX4RMSE, 734028/8E, 734028/10E, 734026CX4RMSE, 734026/8E, 734026/10E, 734024CX4RMSE, 734024/8E, 734024/10E, 734022CX4RMSE, 734022/8E, 734022/10E, 734020CX4RMSE, 734020/8E, 734020/10E, 734018/8E, 73341088E, 73341088/8RME, 73341088/8E, 73341088/10RME, 73341088/10E, 73321488/8ARME, 7332148/10RMFE, 7332148/10RMEE, 733212810/10STDE, 7332128/10RMFE, 7332128/10RMEE, 73321088E, 73321088/8SDE, 73321088/8RME, 73321088/8E, 73321088/10RME, 73321088/10E, 7330888/8E, 7330668/6E, 733038E, 733036E, 733034E, 733032E, 733030E, 733028E, 733026E, 733024E, 733024/6AE, 733022E, 733022/6AE, 733020E, 733020/6AE, 733018E, 733018/6AE, 733016E, 733014E, 73301488/8ARME, 7330148/10RMFE, 7330148/10RMEE, 73301412/10ETE, 733012E, 733012810/10STDE, 7330128/10RMFE, 7330128/10RMEE, 733010E, 73301088E, 73301088/8SDE, 73301088/8RME, 73301088/8E, 73301088/10RME, 73301088/10E, 733010108/8S4E, 733010108/8RME, 733010/10RME, 733008E, 733006E, 7328888/8E, 7328668/6E, 73281488/8ARME, 7328148/10RMEE, 73281412/10ETE, 73281288/8E, 732812810/10STDE, 7328128/10RMFE, 7328128/10RMEE, 73281088E, 73281088/8SDE, 73281088/8RME, 73281088/8E, 73281088/10RME, 73281088/10E, 732810108/8S4E, 7326888/8E, 7326668/6E, 73261488/8ARME, 7326148/10RMEE, 732612810/10STDE, 7326128/10RMFE, 7326128/10RMEE, 73261088E, 73261088/8SDE, 73261088/8RME, 73261088/8E, 73261088/10RME, 73261088/10E, 732610108/8S4E, 732610/10RME, 732528E, 732526E, 732524E, 732522E, 732520E, 732518E, 7324888/8E, 7324668/6E, 73241488/8ARME, 7324148/10RMEE, 732412E, 732412810/10STDE, 7324128/10RMEE, 732412/6E, 73241088E, 73241088/8SDE, 73241088/8RME, 73241088/8E, 73241088/10RME, 73241088/10E, 732410108/8S4E, 73221488/8ARME, 732214/10/10CRME, 732212810/10STDE, 732212/10/8CRME, 732212/10/8ARME, 732211E, 73221088/8RME, 73221088/8E, 73221088/10E, 732210108/8S4E, 7320888/8E, 7320668/6E, 732038E, 732034E, 732034CX4RME, 732034/8E, 732034/10E, 732032E, 732032CX4RME, 732032/8E, 732032/10E, 732030E, 732030CX4RME, 732030/8E, 732030/10E, 732028CX4RME, 732028/8E, 732028/10E, 732026CX4RME, 732026/8E, 732026/10E, 732024CX4RME, 732024/8E, 732024/10E, 732022/10E, 732014/8X2E, 732014/8X2AE, 732014/10X2E, 732014/10X2AE, 732012810/10STDE, 732012/8X2E, 732012/8X2AE, 732012/10X2E, 732010E, 73201088/8RME, 73201088/8E, 732010108/8S4E, 732010/6E, 731809E, 731809/6E, 731608XL55E, 731608E, 731608/8/10RME, 731608/6E, 731608/10/10RME, 731516E, 731514E, 731512E, 731510E, 731508E, 731506E, 7314108/10RME, 731407XL55E,", "code_info": "All Gelsoft Plus devices (any item number ending 'E-B' e.g. 631206PE-B); REF, Item Number, UDI-DI(GTIN):\n635024PE, 635024PE-B, 5037881166636;\n631514PE, 631514PE-B, 5037881166858;\n631222PE, 631222PE-B, 5037881166896;\n633008PE, 633008PE-B, 5037881166698;\n633010PE, 633010PE-B, 5037881166711;\n633007PE, 633007PE-B, 5037881166681;\n636010PE, 636010PE-B, 5037881166520;\n632522PE, 632522PE-B, 5037881166780;\n633012PE, 633012PE-B, 5037881166728;\n635018PE, 635018PE-B, 5037881166605;\n631516PE, 631516PE-B, 5037881166865;\n636016PE, 636016PE-B, 5037881166551;\n631220PE, 631220PE-B, 5037881166889;\n631608PE, 631608PE-B, 5037881166933;\n631206PE, 631206PE-B, 5037881166919;\n631407P50E, 631407P50E-B, 5037881167008;\n631508PE, 631508PE-B, 5037881166827;\n636008PE, 636008PE-B, 5037881166513;\n636006PE, 636006PE-B, 5037881166063;\n632518PE, 632518PE-B, 5037881166759;\n634008PE, 634008PE-B, 5037881166667;\n634006PE, 634006PE-B, 5037881166643;\n631218PE, 631218PE-B, 5037881166872;\n632211PE, 632211PE-B, 5037881166971;\n634007PE, 634007PE-B, 5037881166650;\n633006PE, 633006PE-B, 5037881166674;\n631506PE, 631506PE-B, 5037881166803;\n632524PE, 632524PE-B, 5037881166797;\n636007PE, 636007PE-B, 5037881166506;\n631512PE,631512PE-B, 5037881166841;\n636012PE, 636012PE-B, 5037881166537;\n636014PE, 636014PE-B, 5037881166544;\n632211P50E, 632211P50E-B, 5037881167046;\n633016PE, 633016PE-B, 5037881166742;\n631407PE, 631407PE-B, 5037881166926;\n631809PE, 631809PE-B, 5037881166940;\n632010PE, 632010PE-B, 5037881166964;\n631608P50E, 631608P50E-B, 5037881167015;\n632520PE, 632520PE-B, 5037881166773;\n632412PE, 632412PE-B, 5037881166988;\n631510PE, 631510PE-B, 5037881166834;\n635022PE, 635022PE-B, 5037881166629;\n631224PE, 631224PE-B, 5037881166902;\n632412P50E, 632412P50E-B, 5037881167053;\n631507PE, 631507PE-B, 5037881166810;\n633014PE, 633014PE-B, 5037881166735;\n632010P50E, 632010P50E-B, 5037881167039;\n635020PE, 635020PE-B, 5037881166612;\n631809P50E, 631809P50E-B, 5037881167022.\n\nAll Gelweave devices (any item number ending E-B e.g. 7320128/10RMEE-B); REF, Item Number, UDI-DI(GTIN):\n736038E, 736038E-B, 5037881169415;\n736036E, 736036E-B, 5037881169408;\n736034E, 736034E-B, 5037881169392;\n736032ST/10DE, 736032ST/10DE-B, 5037881172620;\n736032E, 736032E-B, 5037881169385;\n736030ST/10DE, 736030ST/10DE-B, 5037881172637;\n736030E\t, 736030E-B, 5037881169378;\n736028ST/10DE, 736028ST/10DE-B, 5037881172644;\n736028E, 736028E-B, 5037881169361;\n736026ST/10DE, 736026ST/10DE-B, 5037881172651;\n736026E, 736026E-B, 5037881169354;\n736024ST/10DE, 736024ST/10DE-B, 5037881172668;\n736024E, 736024E-B, 5037881169347;\n736022ST/10DE, 736022ST/10DE-B, 5037881172675;\n736022E, 736022E-B, 5037881169330;\n736020E, 736020E-B, 5037881169323;\n736018E, 736018E-B, 5037881169316;\n736016E, 736016E-B, 5037881114057;\n736014E, 736014E-B, 5037881114040;\n736012E, 736012E-B, 5037881168548;\n736010E, 736010E-B, 5037881168517;\n736008E, 736008E-B, 5037881168494;\n736006E, 736006E-B, 5037881166056;\n735034ST/8AE, 735034ST/8AE-B, 5037881173061;\n735034/8RME, 735034/8RME-B, 5037881170039;\n735034/10SEE, 735034/10SEE-B, 5037881171883;\n735034/10RME, 735034/10RME-B, 5037881169958;\n735032STE, 735032STE-B, 5037881175102;\n735032ST/8AE, 735032ST/8AE-B, 5037881173078;\n735032/8SE, 735032/8SE-B, 5037881172095;\n735032/8RME, 735032/8RME-B, 5037881170046;\n735032/10SEE, 735032/10SEE-B, 5037881171890;\n735032/10RME, 735032/10RME-B, 5037881169965;\n735030STE, 735030STE-B, 5037881175126;\n735030ST/8AE, 735030ST/8AE-B, 5037881173085;\n735030/8SE, 735030/8SE-B, 5037881172101;\n735030/8RME, 735030/8RME-B, 5037881170053;\n735030/10SEE, 735030/10SEE-B, 5037881171906;\n735030/10RME, 735030/10RME-B, 5037881169972;\n735028STE, 735028STE-B, 5037881175133;\n735028ST/8AE, 735028ST/8AE-B, 5037881173092;\n735028E, 735028E-B\t5037881168876;\n735028/8SE, 735028/8SE-B, 5037881172118;\n735028/8RME, 735028/8RME-B, 5037881170060;\n735028/10RME, 735028/10RME-B, 5037881169989;\n735026STE, 735026STE-B, 5037881175140;\n735026ST/8AE, 735026ST/8AE-B, 5037881173108;\n735026E, 735026E-B, 5037881168869;\n735026/8SE, 735026/8SE-B, 5037881172125;\n735026/8RME, 735026/8RME-B, 5037881170077;\n735026/10RME, 735026/10RME-B, 5037881169996;\n735024STE, 735024STE-B, 5037881175164;\n735024ST/8AE, 735024ST/8AE-B, 5037881173115;\n735024E, 735024E-B, 5037881168845;\n735024/8SE, 735024/8SE-B, 5037881172132;\n735024/8RME, 735024/8RME-B, 5037881170084;\n735024/10SEE, 735024/10SEE-B, 5037881171937;\n735024/10RME, 735024/10RME-B, 5037881170008;\n735022STE, 735022STE-B, 5037881175188;\n735022E, 735022E-B, 5037881168838;\n735022/8SE, 735022/8SE-B, 5037881172149;\n735022/8RME, 735022/8RME-B, 5037881170091;\n735020E, 735020E-B, 5037881168821;\n735020/8RME, 735020/8RME-B, 5037881170107;\n735018E, 735018E-B, 5037881168814;\n734038E, 734038E-B, 5037881169309;\n734036E, 734036E-B, 5037881169293;\n734034E, 734034E-B, 5037881169286;\n734034CX4RMSE, 734034CX4RMSE-B, 5037881170794;\n734034/8E, 734034/8E-B, 5037881172460;\n734034/10E, 734034/10E-B, 5037881172224;\n734032E, 734032E-B, 5037881169279;\n734032CX4RMSE, 734032CX4RMSE-B, 5037881170800;\n734032/8E, 734032/8E-B, 5037881172477;\n734032/10E, 734032/10E-B, 5037881172231;\n734030E, 734030E-B, 5037881169262;\n734030CX4RMSE, 734030CX4RMSE-B, 5037881170817;\n734030/8E, 734030/8E-B, 5037881172484;\n734030/10E, 734030/10E-B, 5037881172262;\n734028CX4RMSE, 734028CX4RMSE-B, 5037881170824;\n734028/8E, 734028/8E-B, 5037881172491;\n734028/10E, 734028/10E-B, 5037881172286;\n734026CX4RMSE, 734026CX4RMSE-B, 5037881170831;\n734026/8E, 734026/8E-B, 5037881172507;\n734026/10E, 734026/10E-B, 5037881172309;\n734024CX4RMSE, 734024CX4RMSE-B, 5037881170848;\n734024/8E, 734024/8E-B, 5037881172514;\n734024/10E, 734024/10E-B, 5037881172323;\n734022CX4RMSE, 734022CX4RMSE-B, 5037881170855;\n734022/8E, 734022/8E-B, 5037881172521;\n734022/10E, 734022/10E-B, 5037881172347;\n734020CX4RMSE, 734020CX4RMSE-B, 5037881170862;\n734020/8E, 734020/8E-B, 5037881172538;\n734020/10E, 734020/10E-B, 5037881172354;\n734018/8E, 734018/8E-B, 5037881172545;\n73341088E, 73341088E-B, 5037881171562;\n73341088/8RME, 73341088/8RME-B, 5037881169873;\n73341088/8E, 73341088/8E-B, 5037881171371;\n73341088/10RME, 73341088/10RME-B, 5037881169774;\n73341088/10E, 73341088/10E-B, 5037881171296;\n73321488/8ARME, 73321488/8ARME-B, 5037881171043;\n7332148/10RMFE, 7332148/10RMFE-B, 5037881174136;\n7332148/10RMEE, 7332148/10RMEE-B, 5037881174334;\n733212810/10STDE, 733212810/10STDE-B, 5037881172552;\n7332128/10RMFE, 7332128/10RMFE-B, 5037881174266;\n7332128/10RMEE, 7332128/10RMEE-B, 5037881174433;\n73321088E, 73321088E-B, 5037881171579;\n73321088/8SDE, 73321088/8SDE-B, 5037881172699;\n73321088/8RME, 73321088/8RME-B, 5037881169880;\n73321088/8E, 73321088/8E-B, 5037881171388;\n73321088/10RME, 73321088/10RME-B, 5037881169781;\n73321088/10E, 73321088/10E-B, 5037881171302;\n7330888/8E, 7330888/8E-B, 5037881170657;\n7330668/6E, 7330668/6E-B, 5037881170718;\n733038E, 733038E-B, 5037881169163;\n733036E\t, 733036E-B, 5037881169156;\n733034E, 733034E-B, 5037881169149;\n733032E, 733032E-B, 5037881169132;\n733030E, 733030E-B, 5037881169118;\n733028E, 733028E-B, 5037881169101;\n733026E, 733026E-B, 5037881169095;\n733024E, 733024E-B, 5037881169088;\n733024/6AE, 733024/6AE-B, 5037881171845;\n733022E, 733022E-B, 5037881169071;\n733022/6AE, 733022/6AE-B, 5037881171852;\n733020E, 733020E-B, 5037881169064;\n733020/6AE, 733020/6AE-B, 5037881171869;\n733018E, 733018E-B, 5037881169057;\n733018/6AE, 733018/6AE-B, 5037881171876;\n733016E, 733016E-B, 5037881168715;\n733014E, 733014E-B, 5037881168708;\n73301488/8ARME, 73301488/8ARME-B, 5037881171050;\n7330148/10RMFE, 7330148/10RMFE-B, 5037881174150;\n7330148/10RMEE, 7330148/10RMEE-B, 5037881174358;\n73301412/10ETE, 73301412/10ETE-B, 5037881170206;\n733012E, 733012E-B, 5037881168692;\n733012810/10STDE, 733012810/10STDE-B, 5037881172569;\n7330128/10RMFE, 7330128/10RMFE-B, 5037881174273;\n7330128/10RMEE, 7330128/10RMEE-B, 5037881174440;\n733010E, 733010E-B, 5037881168678;\n73301088E, 73301088E-B, 5037881171586;\n73301088/8SDE, 73301088/8SDE-B, 5037881172705;\n73301088/8RME, 73301088/8RME-B, 5037881169897;\n73301088/8E, 73301088/8E-B, 5037881171395;\n73301088/10RME, 73301088/10RME-B, 5037881169811;\n73301088/10E, 73301088/10E-B, 5037881171319;\n733010108/8S4E, 733010108/8S4E-B, 5037881170589;\n733010108/8RME, 733010108/8RME-B, 5037881169576;\n733010/10RME, 733010/10RME-B, 5037881169729;\n733008E, 733008E-B, 5037881168654;\n733006E, 733006E-B, 5037881168616;\n7328888/8E, 7328888/8E-B, 5037881170664;\n7328668/6E, 7328668/6E-B, 5037881170725;\n73281488/8ARME, 73281488/8ARME-B, 5037881171067;\n7328148/10RMEE, 7328148/10RMEE-B, 5037881174365;\n73281412/10ETE, 73281412/10ETE-B, 5037881170213;\n73281288/8E, 73281288/8E-B, 5037881171289;\n732812810/10STDE, 732812810/10STDE-B, 5037881172576;\n7328128/10RMFE, 7328128/10RMFE-B, 5037881174280;\n7328128/10RMEE, 7328128/10RMEE-B, 5037881174457;\n73281088E, 73281088E-B, 5037881171593;\n73281088/8SDE, 73281088/8SDE-B, 5037881172712;\n73281088/8RME, 73281088/8RME-B, 5037881169903;\n73281088/8E, 73281088/8E-B, 5037881171401;\n73281088/10RME, 73281088/10RME-B, 5037881169828;\n73281088/10E, 73281088/10E-B, 5037881171326;\n732810108/8S4E, 732810108/8S4E-B, 5037881170596;\n7326888/8E, 7326888/8E-B, 5037881170671;\n7326668/6E, 7326668/6E-B, 5037881170732;\n73261488/8ARME, 73261488/8ARME-B, 5037881171074;\n7326148/10RMEE, 7326148/10RMEE-B, 5037881174372;\n732612810/10STDE, 732612810/10STDE-B, 5037881172583;\n7326128/10RMFE, 7326128/10RMFE-B, 5037881174297;\n7326128/10RMEE, 7326128/10RMEE-B, 5037881174464;\n73261088E, 73261088E-B, 5037881171609;\n73261088/8SDE, 73261088/8SDE-B, 5037881172729;\n73261088/8RME, 73261088/8RME-B, 5037881169910;\n73261088/8E, 73261088/8E-B, 5037881171418;\n73261088/10RME, 73261088/10RME-B, 5037881169835;\n73261088/10E, 73261088/10E-B, 5037881171333;\n732610108/8S4E, 732610108/8S4E-B, 5037881170602;\n732610/10RME, 732610/10RME-B, 5037881169743;\n732528E, 732528E-B, 5037881168982;\n732526E, 732526E-B, 5037881168975;\n732524E, 732524E-B, 5037881168968;\n732522E, 732522E-B, 5037881168951;\n732520E, 732520E-B, 5037881168944;\n732518E, 732518E-B, 5037881168937;\n7324888/8E, 7324888/8E-B, 5037881170688;\n7324668/6E, 7324668/6E-B, 5037881170749;\n73241488/8ARME, 73241488/8ARME-B, 5037881171081;\n7324148/10RMEE, 7324148/10RMEE-B, 5037881174389;\n732412E, 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732022/10E-B, 5037881172217;\n732014/8X2E, 732014/8X2E-B, 5037881171739;\n732014/8X2AE, 732014/8X2AE-B, 5037881176277;\n732014/10X2E, 732014/10X2E-B, 5037881171722;\n732014/10X2AE, 732014/10X2AE-B, 5037881175355;\n732012810/10STDE, 732012810/10STDE-B, 5037881172613;\n732012/8X2E, 732012/8X2E-B, 5037881171753;\n732012/8X2AE, 732012/8X2AE-B, 5037881175324;\n732012/10X2E, 732012/10X2E-B, 5037881171746;\n732010E, 732010E-B, 5037881174822;\n73201088/8RME, 73201088/8RME-B, 5037881169941;\n73201088/8E, 73201088/8E-B, 5037881171449;\n732010108/8S4E, 732010108/8S4E-B, 5037881170633;\n732010/6E, 732010/6E-B, 5037881174976;\n731809E, 731809E-B, 5037881174792;\n731809/6E, 731809/6E-B, 5037881174945;\n731608XL55E, 731608XL55E-B, 5037881175348;\n731608E, 731608E-B, 5037881174747;\n731608/8/10RME, 731608/8/10RME-B, 5037881175195;\n731608/6E, 731608/6E-B, 5037881174921;\n731608/10/10RME, 731608/10/10RME-B, 5037881175201;\n731516E, 731516E-B, 5037881168807;\n731514E, 731514E-B, 5037881168791;\n731512E, 731512E-B, 5037881168784;\n731510E, 731510E-B, 5037881168760;\n731508E, 731508E-B, 5037881168746;\n731506E, 731506E-B, 5037881168722;\n7314108/10RME, 7314108/10RME-B, 5037881176468;\n731407XL55E, 731407XL55E-B, 5037881175362;\n731407E, 731407E-B, 5037881174686;\n731407/7E, 731407/7E-B, 5037881175119;\n731407/10/10RME, 731407/10/10RME-B, 5037881175218;\n731228E, 731228E-B, 5037881169040;\n731226E, 731226E-B, 5037881169033;\n731224E, 731224E-B, 5037881169026;\n731222E, 731222E-B, 5037881169019;\n731220E, 731220E-B, 5037881169002;\n731218E, 731218E-B, 5037881168999;\n7312108/10RME, 7312108/10RME-B, 5037881176444;\n731210/8X2E, 731210/8X2E-B, 5037881171456;\n731206XL55E, 731206XL55E-B, 5037881175379;\n731206E, 731206E-B, 5037881174631;\n731206/10/10RME, 731206/10/10RME-B, 5037881175225;\n731038E, 731038E-B, 5037881169217;\n731036E, 731036E-B, 5037881169200;\n731034E, 731034E-B, 5037881169194;\n731032E, 731032E-B, 5037881169187;\n731030E, 731030E-B, 5037881169170;\n731010/8X2E, 731010/8X2E-B, 5037881171463;\n730034ADPE, 730034ADPE-B, 5037881173986;\n730032ADPSLE, 730032ADPSLE-B, 5037881173603;\n730032ADPE, 730032ADPE-B, 5037881173993;\n730030ADPSLE, 730030ADPSLE-B, 5037881173634;\n730030ADPE, 730030ADPE-B, 5037881174013;\n730028ADPSLE, 730028ADPSLE-B, 5037881173641;\n730028ADPE, 730028ADPE-B, 5037881174037;\n730026ADPE, 730026ADPE-B, 5037881174044;\n730024ADPE, 730024ADPE-B, 5037881174051;\n730022ADPE, 730022ADPE-B, 5037881174068;\n730020ADPE, 730020ADPE-B, 5037881174082;\n730018ADPE, 730018ADPE-B, 5037881174099;\n730016ADPE, 730016ADPE-B, 5037881174112.", "firm_fei_number": "3002808437", "recalling_firm": "Vascutek, Ltd.", "address_1": "Newmains Avenue", "city": "Inchinnan", "country": "United Kingdom", "additional_info_contact": "Adrienne Day\n441418125555", "reason_for_recall": "Gelatin sealed woven polyester prostheses devices, designed for vascular repair, were incorrectly labeled with an additional month of shelf life. Device expiry should have been calculated from gel impregnation (date of manufacture) but it was incorrectly calculated from device packaging.", "root_cause_description": "Error in labeling", "action": "On 12/18/2025, Field Safety Notices were emailed to customers who were asked to do the following:\n\nAwareness of this Field Safety Notice is advised and shall be distributed to operating surgeons and users. The shelf life ranges (expiry dates) have now been corrected for all newly manufactured products.\n\nPlease share this information with anyone in your organization who needs to be aware or is a user of the affected devices. \n\nComplete and return the Field Safety Notice Return Confirmation form to: taukfsn2025-003shelflife@terumoaortic.com Questions can be sent to the this email address as well.", "product_quantity": "37430", "distribution_pattern": "US Nationwide distribution including in the states of FL, PA, TX, NC, NY, CA, NJ, OH, MI, DC, CO, VA, GA, IL, OR, ND, VT, MS, MA, IN, WA, AZ, MN, MD, IA, OK, MO, AL, WI, LA, AR, TN, CT, ME, NE, SC, KS, NV, KY, RI, WV, UT, MT, ID, AK, NH, DE, NM, SD, HI, WY.", "openfda": { "k_number": [ "K954582", "K150389", "K130016", "K933987", "K811510", "K800149", "K130215", "K162794", "K955460", "K202471", "K013577", "K231972", "K833716", "K983064", "K862739", "K231505", "K962433", "K962639", "K831865", "K060741", "K240083", "K896964", "K901641", "K002007", "K041528", "K252277", "K803000", "K000499", "K880167", "K882289", "K013022", "K953288", "K093934", "K870884", "K992832", "K131778", "K955230", "K983861", "K955532", "K821716", "K831822", "K051332", "K013651", "K130142", "K812248", "K963790", "K051312", "K172637", "K252445", "K944858", "K861808", "K890182", "K961134", "K770235", "K912911", "K043552", "K102596", "K091778", "K122138", "K955588", "K801621", "K884083", "K854845", "K791828", "K981079", "K922905", "K183613", "K113101", "K901682", "K121532", "K961847", "K830543", "K233783", "K050049", "K802095", "K984294", "K810845", "K970843", "K903964", "K241550", "K910865", "K992960", "K832806", "K910864", "K092863", "K853725", "K034010", "K903931", "K820696", "K952293", "K941981", "K203724", "K862697", "K940816", "K854431", "K032900", "K071778", "K013250", "K021547", "K124039", "K010517", "K894732", "K905067", "K822633", "K880040", "K991027", "K914116", "K913143", "K933204", "K052282", "K990800", "K821158", "K871110", "K984182", "K964197", "K153523", "K990503", "K940062", "K991602", "K933590", "K083169", "K841596", "K933943", "K062161", "K071923", "K880041", "K040829", "K052964", "K022242", "K905270", "K180957", "K162803", "K910866", "K811441", "K241070", "K004011", "K971192", "K801156", "K012952", "K001927", "K090987", "K060142", "K831880", "K760091", "K760090", "K904282", "K960706", "K060124", "K830016", "K061626", "K853101", "K202703", "K910863", "K142062", "K020767", "K881283", "K091491", "K983819", "K964625", "K760092", "K890597", "K914447", "K760130", "K964665", "K810376", "K120006", "K010516", "K141124", "K993667", "K905269", "K882314", "K893459", "K922025", "K103347", "K232312", "K925123", "K233551", "K770236", "K991813", "K221628", "K030999", "K093817", "K094044", "K992443", "K820600", "K964959", "K213845", "K771819" ], "pma_number": [ "P840029" ], "registration_number": [ "2020394", "3011175548", "1220948", "1018233", "3007676031", "3015225571", "9612515", "1721504", "3006950086", "3012536737", "3013718163", "3015309643", "1724474", "1720929", "1723241", "2246552", "1721676", "3010407203", "3010162973", "3033589330", "3006082230", "3008307705", "3010097171", "3045042524", "1640201", "2242352", "1220477", "2017233" ], "fei_number": [ "2020394", "3011175548", "1220948", "1018233", "3007676031", "3003094851", "3015225571", "3002707083", "1721504", "3006950086", "3012536737", "3013718163", "3015309643", "1720929", "2246552", "1721676", "3002808437", "1000517719", "3010407203", "3002807041", "3033589330", "3006082230", "3008307705", "3010097171", "3045042524", "2242352", "1220477", "2017233" ], "device_name": "Prosthesis, Vascular Graft, Of 6mm And Greater Diameter", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.3450", "device_class": "2" } } ] }