Gelsoft Plus, REF: 635024PE, 631514PE, 631222PE, 633008PE… recallZ-1492-2026 · Vascutek, Ltd. · initiated Dec 18, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Vascutek, Ltd. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Error in labeling
What the company is doing
On 12/18/2025, Field Safety Notices were emailed to customers who were asked to do the following: Awareness 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. Please share this information with anyone in your organization who needs to be aware or is a user of the affected devices. Complete and return the Field Safety Notice Return Confirmation form to: [email protected] Questions can be sent to the this email address as well.
Recall details
- Recall number
- Z-1492-2026
- Status
- Open, Classified
- Initiated by the company
- Dec 18, 2025
- Posted by the FDA
- Mar 4, 2026
- Recalling firm
- Vascutek, Ltd.
- Quantity
- 37430
- Product code
- DSY
- FDA submissions
- K241070, K241550
- Distribution
- 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.
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,
Code information (models, lots, serial numbers)
Show the full code information (15k characters)
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.
Devices named in this recall
348 devices in the FDA device registry whose identifier appears in the recall's code information; the 100 most reported are shown.
- Gelweave Vascular Prostheses 733010EVascutek Ltd · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall2 reports
- Gelsoft Plus Vascular Prostheses 634006PEVascutek Ltd · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall1 report
- Gelsoft Plus Vascular Prostheses 631508PEVascutek Ltd · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall1 report
- Gelweave Vascular Prostheses 736014EVascutek Ltd · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelweave Vascular Prostheses 736016EVascutek Ltd · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelweave Vascular Prostheses 736006EVascutek Ltd · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelsoft Plus Vascular Prostheses 636006PEVascutek Ltd · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelsoft Plus Vascular Prostheses 636007PEVascutek Ltd · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelsoft Plus Vascular Prostheses 636008PEVascutek Ltd · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelsoft Plus Vascular Prostheses 636010PEVascutek Ltd · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelsoft Plus Vascular Prostheses 636012PEVascutek Ltd · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelsoft Plus Vascular Prostheses 636014PEVascutek Ltd · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelsoft Plus Vascular Prostheses 636016PEVascutek Ltd · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelsoft Plus Vascular Prostheses 635018PEVascutek Ltd · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelsoft Plus Vascular Prostheses 635020PEVascutek Ltd · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelsoft Plus Vascular Prostheses 635022PEVascutek Ltd · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelsoft Plus Vascular Prostheses 635024PEVascutek Ltd · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelsoft Plus Vascular Prostheses 634007PEVascutek Ltd · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelsoft Plus Vascular Prostheses 634008PEVascutek Ltd · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelsoft Plus Vascular Prostheses 633006PEVascutek Ltd · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelsoft Plus Vascular Prostheses 633007PEVascutek Ltd · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelsoft Plus Vascular Prostheses 633008PEVascutek Ltd · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelsoft Plus Vascular Prostheses 633010PEVascutek Ltd · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelsoft Plus Vascular Prostheses 633012PEVascutek Ltd · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelsoft Plus Vascular Prostheses 633014PEVascutek Ltd · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelsoft Plus Vascular Prostheses 633016PEVascutek Ltd · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelsoft Plus Vascular Prostheses 632518PEVascutek Ltd · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelsoft Plus Vascular Prostheses 632520PEVascutek Ltd · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelsoft Plus Vascular Prostheses 632522PEVascutek Ltd · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelsoft Plus Vascular Prostheses 632524PEVascutek Ltd · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelsoft Plus Vascular Prostheses 631506PEVascutek Ltd · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelsoft Plus Vascular Prostheses 631507PEVascutek Ltd · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelsoft Plus Vascular Prostheses 631510PEVascutek Ltd · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelsoft Plus Vascular Prostheses 631512PEVascutek Ltd · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelsoft Plus Vascular Prostheses 631514PEVascutek Ltd · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelsoft Plus Vascular Prostheses 631516PEVascutek Ltd · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelsoft Plus Vascular Prostheses 631218PEVascutek Ltd · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelsoft Plus Vascular Prostheses 631220PEVascutek Ltd · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelsoft Plus Vascular Prostheses 631222PEVascutek Ltd · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelsoft Plus Vascular Prostheses 631224PEVascutek Ltd · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelsoft Plus Vascular Prostheses 631206PEVascutek Ltd · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelsoft Plus Vascular Prostheses 631407PEVascutek Ltd · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelsoft Plus Vascular Prostheses 631608PEVascutek Ltd · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelsoft Plus Vascular Prostheses 631809PEVascutek Ltd · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelsoft Plus Vascular Prostheses 632010PEVascutek Ltd · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelsoft Plus Vascular Prostheses 632211PEVascutek Ltd · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelsoft Plus Vascular Prostheses 632412PEVascutek Ltd · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelsoft Plus Vascular Prostheses 631407P50EVascutek Ltd · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelsoft Plus Vascular Prostheses 631608P50EVascutek Ltd · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelsoft Plus Vascular Prostheses 631809P50EVascutek Ltd · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelsoft Plus Vascular Prostheses 632010P50EVascutek Ltd · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelsoft Plus Vascular Prostheses 632211P50EVascutek Ltd · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelsoft Plus Vascular Prostheses 632412P50EVascutek Ltd · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelweave Vascular Prostheses 736008EVascutek Ltd · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelweave Vascular Prostheses 736010EVascutek Ltd · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelweave Vascular Prostheses 736012EVascutek Ltd · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelweave Vascular Prostheses 733006EVascutek Ltd · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelweave Vascular Prostheses 733008EVascutek Ltd · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelweave Vascular Prostheses 733012EVascutek Ltd · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelweave Vascular Prostheses 733014EVascutek Ltd · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelweave Vascular Prostheses 733016EVascutek Ltd · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelweave Vascular Prostheses 731506EVascutek Ltd · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelweave Vascular Prostheses 731508EVascutek Ltd · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelweave Vascular Prostheses 731510EVascutek Ltd · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelweave Vascular Prostheses 731512EVascutek Ltd · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelweave Vascular Prostheses 731514EVascutek Ltd · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelweave Vascular Prostheses 731516EVascutek Ltd · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelweave Vascular Prostheses 735018EVascutek Ltd · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelweave Vascular Prostheses 735020EVascutek Ltd · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelweave Vascular Prostheses 735022EVascutek Ltd · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelweave Vascular Prostheses 735024EVascutek Ltd · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelweave Vascular Prostheses 735026EVascutek Ltd · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelweave Vascular Prostheses 735028EVascutek Ltd · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelweave Vascular Prostheses 732518EVascutek Ltd · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelweave Vascular Prostheses 732520EVascutek Ltd · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelweave Vascular Prostheses 732522EVascutek Ltd · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelweave Vascular Prostheses 732524EVascutek Ltd · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelweave Vascular Prostheses 732526EVascutek Ltd · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelweave Vascular Prostheses 732528EVascutek Ltd · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelweave Vascular Prostheses 731218EVascutek Ltd · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelweave Vascular Prostheses 731220EVascutek Ltd · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelweave Vascular Prostheses 731222EVascutek Ltd · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelweave Vascular Prostheses 731224EVascutek Ltd · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelweave Vascular Prostheses 731226EVascutek Ltd · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelweave Vascular Prostheses 731228EVascutek Ltd · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelweave Vascular Prostheses 733018EVascutek Ltd · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelweave Vascular Prostheses 733020EVascutek Ltd · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelweave Vascular Prostheses 733022EVascutek Ltd · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelweave Vascular Prostheses 733024EVascutek Ltd · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelweave Vascular Prostheses 733026EVascutek Ltd · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelweave Vascular Prostheses 733028EVascutek Ltd · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelweave Vascular Prostheses 733030EVascutek Ltd · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelweave Vascular Prostheses 733032EVascutek Ltd · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelweave Vascular Prostheses 733034EVascutek Ltd · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelweave Vascular Prostheses 733036EVascutek Ltd · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelweave Vascular Prostheses 733038EVascutek Ltd · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelweave Vascular Prostheses 731030EVascutek Ltd · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelweave Vascular Prostheses 731032EVascutek Ltd · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelweave Vascular Prostheses 731034EVascutek Ltd · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
- Gelweave Vascular Prostheses 731036EVascutek Ltd · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page