Gelsoft Plus, REF: 635024PE, 631514PE, 631222PE, 633008PE, 633010PE, 633007PE, 636010PE, 632522PE...
FDA Device Recall #Z-1492-2026 — Class II — December 18, 2025
Recall Summary
| Recall Number | Z-1492-2026 |
| Classification | Class II — Moderate risk |
| Date Initiated | December 18, 2025 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Vascutek, Ltd. |
| Location | Inchinnan, N/A |
| Product Type | Devices |
| Quantity | 37430 |
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. Gelweave, 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,
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.
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.
Lot / Code Information
All Gelsoft Plus devices (any item number ending 'E-B' e.g. 631206PE-B); REF, Item Number, UDI-DI(GTIN): 635024PE, 635024PE-B, 5037881166636; 631514PE, 631514PE-B, 5037881166858; 631222PE, 631222PE-B, 5037881166896; 633008PE, 633008PE-B, 5037881166698; 633010PE, 633010PE-B, 5037881166711; 633007PE, 633007PE-B, 5037881166681; 636010PE, 636010PE-B, 5037881166520; 632522PE, 632522PE-B, 5037881166780; 633012PE, 633012PE-B, 5037881166728; 635018PE, 635018PE-B, 5037881166605; 631516PE, 631516PE-B, 5037881166865; 636016PE, 636016PE-B, 5037881166551; 631220PE, 631220PE-B, 5037881166889; 631608PE, 631608PE-B, 5037881166933; 631206PE, 631206PE-B, 5037881166919; 631407P50E, 631407P50E-B, 5037881167008; 631508PE, 631508PE-B, 5037881166827; 636008PE, 636008PE-B, 5037881166513; 636006PE, 636006PE-B, 5037881166063; 632518PE, 632518PE-B, 5037881166759; 634008PE, 634008PE-B, 5037881166667; 634006PE, 634006PE-B, 5037881166643; 631218PE, 631218PE-B, 5037881166872; 632211PE, 632211PE-B, 5037881166971; 634007PE, 634007PE-B, 5037881166650; 633006PE, 633006PE-B, 5037881166674; 631506PE, 631506PE-B, 5037881166803; 632524PE, 632524PE-B, 5037881166797; 636007PE, 636007PE-B, 5037881166506; 631512PE,631512PE-B, 5037881166841; 636012PE, 636012PE-B, 5037881166537; 636014PE, 636014PE-B, 5037881166544; 632211P50E, 632211P50E-B, 5037881167046; 633016PE, 633016PE-B, 5037881166742; 631407PE, 631407PE-B, 5037881166926; 631809PE, 631809PE-B, 5037881166940; 632010PE, 632010PE-B, 5037881166964; 631608P50E, 631608P50E-B, 5037881167015; 632520PE, 632520PE-B, 5037881166773; 632412PE, 632412PE-B, 5037881166988; 631510PE, 631510PE-B, 5037881166834; 635022PE, 635022PE-B, 5037881166629; 631224PE, 631224PE-B, 5037881166902; 632412P50E, 632412P50E-B, 5037881167053; 631507PE, 631507PE-B, 5037881166810; 633014PE, 633014PE-B, 5037881166735; 632010P50E, 632010P50E-B, 5037881167039; 635020PE, 635020PE-B, 5037881166612; 631809P50E, 631809P50E-B, 5037881167022. All Gelweave devices (any item number ending E-B e.g. 7320128/10RMEE-B); REF, Item Number, UDI-DI(GTIN): 736038E, 736038E-B, 5037881169415; 736036E, 736036E-B, 5037881169408; 736034E, 736034E-B, 5037881169392; 736032ST/10DE, 736032ST/10DE-B, 5037881172620; 736032E, 736032E-B, 5037881169385; 736030ST/10DE, 736030ST/10DE-B, 5037881172637; 736030E , 736030E-B, 5037881169378; 736028ST/10DE, 736028ST/10DE-B, 5037881172644; 736028E, 736028E-B, 5037881169361; 736026ST/10DE, 736026ST/10DE-B, 5037881172651; 736026E, 736026E-B, 5037881169354; 736024ST/10DE, 736024ST/10DE-B, 5037881172668; 736024E, 736024E-B, 5037881169347; 736022ST/10DE, 736022ST/10DE-B, 5037881172675; 736022E, 736022E-B, 5037881169330; 736020E, 736020E-B, 5037881169323; 736018E, 736018E-B, 5037881169316; 736016E, 736016E-B, 5037881114057; 736014E, 736014E-B, 5037881114040; 736012E, 736012E-B, 5037881168548; 736010E, 736010E-B, 5037881168517; 736008E, 736008E-B, 5037881168494; 736006E, 736006E-B, 5037881166056; 735034ST/8AE, 735034ST/8AE-B, 5037881173061; 735034/8RME, 735034/8RME-B, 5037881170039; 735034/10SEE, 735034/10SEE-B, 5037881171883; 735034/10RME, 735034/10RME-B, 5037881169958; 735032STE, 735032STE-B, 5037881175102; 735032ST/8AE, 735032ST/8AE-B, 5037881173078; 735032/8SE, 735032/8SE-B, 5037881172095; 735032/8RME, 735032/8RME-B, 5037881170046; 735032/10SEE, 735032/10SEE-B, 5037881171890; 735032/10RME, 735032/10RME-B, 5037881169965; 735030STE, 735030STE-B, 5037881175126; 735030ST/8AE, 735030ST/8AE-B, 5037881173085; 735030/8SE, 735030/8SE-B, 5037881172101; 735030/8RME, 735030/8RME-B, 5037881170053; 735030/10SEE, 735030/10SEE-B, 5037881171906; 735030/10RME, 735030/10RME-B, 5037881169972; 735028STE, 735028STE-B, 5037881175133; 735028ST/8AE, 735028ST/8AE-B, 5037881173092; 735028E, 735028E-B 5037881168876; 735028/8SE, 735028/8SE-B, 5037881172118; 735028/8RME, 735028/8RME-B, 5037881170060; 735028/10RME, 735028/10RME-B, 5037881169989; 735026STE, 735026STE-B, 5037881175140; 735026ST/8AE, 735026ST/8AE-B, 5037881173108; 735026E, 735026E-B, 5037881168869; 735026/8SE, 735026/8SE-B, 5037881172125; 735026/8RME, 735026/8RME-B, 5037881170077; 735026/10RME, 735026/10RME-B, 5037881169996; 735024STE, 735024STE-B, 5037881175164; 735024ST/8AE, 735024ST/8AE-B, 5037881173115; 735024E, 735024E-B, 5037881168845; 735024/8SE, 735024/8SE-B, 5037881172132; 735024/8RME, 735024/8RME-B, 5037881170084; 735024/10SEE, 735024/10SEE-B, 5037881171937; 735024/10RME, 735024/10RME-B, 5037881170008; 735022STE, 735022STE-B, 5037881175188; 735022E, 735022E-B, 5037881168838; 735022/8SE, 735022/8SE-B, 5037881172149; 735022/8RME, 735022/8RME-B, 5037881170091; 735020E, 735020E-B, 5037881168821; 735020/8RME, 735020/8RME-B, 5037881170107; 735018E, 735018E-B, 5037881168814; 734038E, 734038E-B, 5037881169309; 734036E, 734036E-B, 5037881169293; 734034E, 734034E-B, 5037881169286; 734034CX4RMSE, 734034CX4RMSE-B, 5037881170794; 734034/8E, 734034/8E-B, 5037881172460; 734034/10E, 734034/10E-B, 5037881172224; 734032E, 734032E-B, 5037881169279; 734032CX4RMSE, 734032CX4RMSE-B, 5037881170800; 734032/8E, 734032/8E-B, 5037881172477; 734032/10E, 734032/10E-B, 5037881172231; 734030E, 734030E-B, 5037881169262; 734030CX4RMSE, 734030CX4RMSE-B, 5037881170817; 734030/8E, 734030/8E-B, 5037881172484; 734030/10E, 734030/10E-B, 5037881172262; 734028CX4RMSE, 734028CX4RMSE-B, 5037881170824; 734028/8E, 734028/8E-B, 5037881172491; 734028/10E, 734028/10E-B, 5037881172286; 734026CX4RMSE, 734026CX4RMSE-B, 5037881170831; 734026/8E, 734026/8E-B, 5037881172507; 734026/10E, 734026/10E-B, 5037881172309; 734024CX4RMSE, 734024CX4RMSE-B, 5037881170848; 734024/8E, 734024/8E-B, 5037881172514; 734024/10E, 734024/10E-B, 5037881172323; 734022CX4RMSE, 734022CX4RMSE-B, 5037881170855; 734022/8E, 734022/8E-B, 5037881172521; 734022/10E, 734022/10E-B, 5037881172347; 734020CX4RMSE, 734020CX4RMSE-B, 5037881170862; 734020/8E, 734020/8E-B, 5037881172538; 734020/10E, 734020/10E-B, 5037881172354; 734018/8E, 734018/8E-B, 5037881172545; 73341088E, 73341088E-B, 5037881171562; 73341088/8RME, 73341088/8RME-B, 5037881169873; 73341088/8E, 73341088/8E-B, 5037881171371; 73341088/10RME, 73341088/10RME-B, 5037881169774; 73341088/10E, 73341088/10E-B, 5037881171296; 73321488/8ARME, 73321488/8ARME-B, 5037881171043; 7332148/10RMFE, 7332148/10RMFE-B, 5037881174136; 7332148/10RMEE, 7332148/10RMEE-B, 5037881174334; 733212810/10STDE, 733212810/10STDE-B, 5037881172552; 7332128/10RMFE, 7332128/10RMFE-B, 5037881174266; 7332128/10RMEE, 7332128/10RMEE-B, 5037881174433; 73321088E, 73321088E-B, 5037881171579; 73321088/8SDE, 73321088/8SDE-B, 5037881172699; 73321088/8RME, 73321088/8RME-B, 5037881169880; 73321088/8E, 73321088/8E-B, 5037881171388; 73321088/10RME, 73321088/10RME-B, 5037881169781; 73321088/10E, 73321088/10E-B, 5037881171302; 7330888/8E, 7330888/8E-B, 5037881170657; 7330668/6E, 7330668/6E-B, 5037881170718; 733038E, 733038E-B, 5037881169163; 733036E , 733036E-B, 5037881169156; 733034E, 733034E-B, 5037881169149; 733032E, 733032E-B, 5037881169132; 733030E, 733030E-B, 5037881169118; 733028E, 733028E-B, 5037881169101; 733026E, 733026E-B, 5037881169095; 733024E, 733024E-B, 5037881169088; 733024/6AE, 733024/6AE-B, 5037881171845; 733022E, 733022E-B, 5037881169071; 733022/6AE, 733022/6AE-B, 5037881171852; 733020E, 733020E-B, 5037881169064; 733020/6AE, 733020/6AE-B, 5037881171869; 733018E, 733018E-B, 5037881169057; 733018/6AE, 733018/6AE-B, 5037881171876; 733016E, 733016E-B, 5037881168715; 733014E, 733014E-B, 5037881168708; 73301488/8ARME, 73301488/8ARME-B, 5037881171050; 7330148/10RMFE, 7330148/10RMFE-B, 5037881174150; 7330148/10RMEE, 7330148/10RMEE-B, 5037881174358; 73301412/10ETE, 73301412/10ETE-B, 5037881170206; 733012E, 733012E-B, 5037881168692; 733012810/10STDE, 733012810/10STDE-B, 5037881172569; 7330128/10RMFE, 7330128/10RMFE-B, 5037881174273; 7330128/10RMEE, 7330128/10RMEE-B, 5037881174440; 733010E, 733010E-B, 5037881168678; 73301088E, 73301088E-B, 5037881171586; 73301088/8SDE, 73301088/8SDE-B, 5037881172705; 73301088/8RME, 73301088/8RME-B, 5037881169897; 73301088/8E, 73301088/8E-B, 5037881171395; 73301088/10RME, 73301088/10RME-B, 5037881169811; 73301088/10E, 73301088/10E-B, 5037881171319; 733010108/8S4E, 733010108/8S4E-B, 5037881170589; 733010108/8RME, 733010108/8RME-B, 5037881169576; 733010/10RME, 733010/10RME-B, 5037881169729; 733008E, 733008E-B, 5037881168654; 733006E, 733006E-B, 5037881168616; 7328888/8E, 7328888/8E-B, 5037881170664; 7328668/6E, 7328668/6E-B, 5037881170725; 73281488/8ARME, 73281488/8ARME-B, 5037881171067; 7328148/10RMEE, 7328148/10RMEE-B, 5037881174365; 73281412/10ETE, 73281412/10ETE-B, 5037881170213; 73281288/8E, 73281288/8E-B, 5037881171289; 732812810/10STDE, 732812810/10STDE-B, 5037881172576; 7328128/10RMFE, 7328128/10RMFE-B, 5037881174280; 7328128/10RMEE, 7328128/10RMEE-B, 5037881174457; 73281088E, 73281088E-B, 5037881171593; 73281088/8SDE, 73281088/8SDE-B, 5037881172712; 73281088/8RME, 73281088/8RME-B, 5037881169903; 73281088/8E, 73281088/8E-B, 5037881171401; 73281088/10RME, 73281088/10RME-B, 5037881169828; 73281088/10E, 73281088/10E-B, 5037881171326; 732810108/8S4E, 732810108/8S4E-B, 5037881170596; 7326888/8E, 7326888/8E-B, 5037881170671; 7326668/6E, 7326668/6E-B, 5037881170732; 73261488/8ARME, 73261488/8ARME-B, 5037881171074; 7326148/10RMEE, 7326148/10RMEE-B, 5037881174372; 732612810/10STDE, 732612810/10STDE-B, 5037881172583; 7326128/10RMFE, 7326128/10RMFE-B, 5037881174297; 7326128/10RMEE, 7326128/10RMEE-B, 5037881174464; 73261088E, 73261088E-B, 5037881171609; 73261088/8SDE, 73261088/8SDE-B, 5037881172729; 73261088/8RME, 73261088/8RME-B, 5037881169910; 73261088/8E, 73261088/8E-B, 5037881171418; 73261088/10RME, 73261088/10RME-B, 5037881169835; 73261088/10E, 73261088/10E-B, 5037881171333; 732610108/8S4E, 732610108/8S4E-B, 5037881170602; 732610/10RME, 732610/10RME-B, 5037881169743; 732528E, 732528E-B, 5037881168982; 732526E, 732526E-B, 5037881168975; 732524E, 732524E-B, 5037881168968; 732522E, 732522E-B, 5037881168951; 732520E, 732520E-B, 5037881168944; 732518E, 732518E-B, 5037881168937; 7324888/8E, 7324888/8E-B, 5037881170688; 7324668/6E, 7324668/6E-B, 5037881170749; 73241488/8ARME, 73241488/8ARME-B, 5037881171081; 7324148/10RMEE, 7324148/10RMEE-B, 5037881174389; 732412E, 732412E-B, 5037881174907; 732412810/10STDE, 732412810/10STDE-B, 5037881172590; 7324128/10RMEE, 7324128/10RMEE-B, 5037881174495; 732412/6E, 732412/6E-B, 5037881174983; 73241088E, 73241088E-B, 5037881171616; 73241088/8SDE, 73241088/8SDE-B, 5037881172736; 73241088/8RME, 73241088/8RME-B, 5037881169927; 73241088/8E, 73241088/8E-B, 5037881171425; 73241088/10RME, 73241088/10RME-B, 5037881169842; 73241088/10E, 73241088/10E-B, 5037881171340; 732410108/8S4E, 732410108/8S4E-B, 5037881170619; 73221488/8ARME, 73221488/8ARME-B, 5037881171098; 732214/10/10CRME, 732214/10/10CRME-B, 5037881171661; 732212810/10STDE, 732212810/10STDE-B, 5037881172606; 732212/10/8CRME, 732212/10/8CRME-B, 5037881171678; 732212/10/8ARME, 732212/10/8ARME-B, 5037881171692; 732211E, 732211E-B, 5037881174839; 73221088/8RME, 73221088/8RME-B, 5037881169934; 73221088/8E, 73221088/8E-B, 5037881171432; 73221088/10E, 73221088/10E-B, 5037881171357; 732210108/8S4E, 732210108/8S4E-B, 5037881170626; 7320888/8E, 7320888/8E-B, 5037881170701; 7320668/6E, 7320668/6E-B, 5037881170763; 732038E, 732038E-B, 5037881169255; 732034E, 732034E-B, 5037881169248; 732034CX4RME, 732034CX4RME-B, 5037881170879; 732034/8E, 732034/8E-B, 5037881172392; 732034/10E, 732034/10E-B, 5037881172156; 732032E, 732032E-B, 5037881169231; 732032CX4RME, 732032CX4RME-B, 5037881170886; 732032/8E, 732032/8E-B, 5037881172408; 732032/10E, 732032/10E-B, 5037881172163; 732030E, 732030E-B, 5037881169224; 732030CX4RME, 732030CX4RME-B, 5037881170893; 732030/8E, 732030/8E-B, 5037881172415; 732030/10E, 732030/10E-B, 5037881172170; 732028CX4RME, 732028CX4RME-B, 5037881170909; 732028/8E, 732028/8E-B, 5037881172422; 732028/10E, 732028/10E-B, 5037881172187; 732026CX4RME, 732026CX4RME-B, 5037881170916; 732026/8E, 732026/8E-B, 5037881172439; 732026/10E, 732026/10E-B, 5037881172194; 732024CX4RME, 732024CX4RME-B, 5037881170923; 732024/8E, 732024/8E-B, 5037881172446; 732024/10E, 732024/10E-B, 5037881172200; 732022/10E, 732022/10E-B, 5037881172217; 732014/8X2E, 732014/8X2E-B, 5037881171739; 732014/8X2AE, 732014/8X2AE-B, 5037881176277; 732014/10X2E, 732014/10X2E-B, 5037881171722; 732014/10X2AE, 732014/10X2AE-B, 5037881175355; 732012810/10STDE, 732012810/10STDE-B, 5037881172613; 732012/8X2E, 732012/8X2E-B, 5037881171753; 732012/8X2AE, 732012/8X2AE-B, 5037881175324; 732012/10X2E, 732012/10X2E-B, 5037881171746; 732010E, 732010E-B, 5037881174822; 73201088/8RME, 73201088/8RME-B, 5037881169941; 73201088/8E, 73201088/8E-B, 5037881171449; 732010108/8S4E, 732010108/8S4E-B, 5037881170633; 732010/6E, 732010/6E-B, 5037881174976; 731809E, 731809E-B, 5037881174792; 731809/6E, 731809/6E-B, 5037881174945; 731608XL55E, 731608XL55E-B, 5037881175348; 731608E, 731608E-B, 5037881174747; 731608/8/10RME, 731608/8/10RME-B, 5037881175195; 731608/6E, 731608/6E-B, 5037881174921; 731608/10/10RME, 731608/10/10RME-B, 5037881175201; 731516E, 731516E-B, 5037881168807; 731514E, 731514E-B, 5037881168791; 731512E, 731512E-B, 5037881168784; 731510E, 731510E-B, 5037881168760; 731508E, 731508E-B, 5037881168746; 731506E, 731506E-B, 5037881168722; 7314108/10RME, 7314108/10RME-B, 5037881176468; 731407XL55E, 731407XL55E-B, 5037881175362; 731407E, 731407E-B, 5037881174686; 731407/7E, 731407/7E-B, 5037881175119; 731407/10/10RME, 731407/10/10RME-B, 5037881175218; 731228E, 731228E-B, 5037881169040; 731226E, 731226E-B, 5037881169033; 731224E, 731224E-B, 5037881169026; 731222E, 731222E-B, 5037881169019; 731220E, 731220E-B, 5037881169002; 731218E, 731218E-B, 5037881168999; 7312108/10RME, 7312108/10RME-B, 5037881176444; 731210/8X2E, 731210/8X2E-B, 5037881171456; 731206XL55E, 731206XL55E-B, 5037881175379; 731206E, 731206E-B, 5037881174631; 731206/10/10RME, 731206/10/10RME-B, 5037881175225; 731038E, 731038E-B, 5037881169217; 731036E, 731036E-B, 5037881169200; 731034E, 731034E-B, 5037881169194; 731032E, 731032E-B, 5037881169187; 731030E, 731030E-B, 5037881169170; 731010/8X2E, 731010/8X2E-B, 5037881171463; 730034ADPE, 730034ADPE-B, 5037881173986; 730032ADPSLE, 730032ADPSLE-B, 5037881173603; 730032ADPE, 730032ADPE-B, 5037881173993; 730030ADPSLE, 730030ADPSLE-B, 5037881173634; 730030ADPE, 730030ADPE-B, 5037881174013; 730028ADPSLE, 730028ADPSLE-B, 5037881173641; 730028ADPE, 730028ADPE-B, 5037881174037; 730026ADPE, 730026ADPE-B, 5037881174044; 730024ADPE, 730024ADPE-B, 5037881174051; 730022ADPE, 730022ADPE-B, 5037881174068; 730020ADPE, 730020ADPE-B, 5037881174082; 730018ADPE, 730018ADPE-B, 5037881174099; 730016ADPE, 730016ADPE-B, 5037881174112.
Other Recalls from Vascutek, Ltd.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2542-2021 | Class II | The Instructions for Use (IFU) for: Gelsoft Pl... | Jul 8, 2021 |
| Z-2543-2021 | Class II | The Instructions for Use (IFU) for: Carotid Pa... | Jul 8, 2021 |
| Z-1912-2015 | Class II | Gelseal Straight Diameter 8mm Length 15cm. V... | May 15, 2015 |
| Z-1913-2015 | Class II | Gelseal Straight Diameter 8mm Length 30cm. V... | May 15, 2015 |
| Z-2266-2014 | Class II | Gelweave (TM) Vascular Prostheses Manufactured... | Jul 15, 2014 |
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.