Class IIOngoingZ-1492-2026
Vascutek, Ltd. recalls Gelsoft Plus
Vascutek, Ltd.Inchinnan, United KingdomReported Mar 11, 2026 · 4 months ago
Legal News Analyst ·
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.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Gelsoft Plus315 codes
- 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
Show 275 more codesShow fewer
- 631510PE
- 635022PE
- 631224PE
- 632412P50E
- 631507PE
- 633014PE
- 632010P50E
- 635020PE
- 631809P50E. Gelweave
- 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
Lot / code information
- Part / Item #
- ending 'E-B' e.g. 631206PE-B)
- GTIN
): 635024PE, 635024PE-B, 5037881166636; 631514PE, 631514PE-B, 5037881166858; 631222PE, 631222PE-B — +93 moreShow all
): 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- Part / Item #
- ending E-B e.g. 7320128/10RMEE-B)
- GTIN
): 736038E, 736038E-B, 5037881169415; 736036E, 736036E-B, 5037881169408; 736034E, 736034E-B — +592 moreShow all
): 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; 7 …
What the firm 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: taukfsn2025-003shelflife@terumoaortic.com Questions can be sent to the this email address as well.
DistributionShow detailsHide
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.
Class IIWhat this means
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-1492-2026
- FDA 510(k) clearance · K241070The device's official FDA premarket clearance record
- FDA 510(k) clearance · K241550The device's official FDA premarket clearance record
- FDA device classification · DSYOfficial FDA classification for this device type
- CFR regulation · 21 CFR 870.3450The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Vascutek, Ltd.Search for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus
Legal News Analyst
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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Class IIOngoingZ-2673-2026
Zimmer Surgical Inc recalls Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet Systems D…
Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. If discovered prior to use, may result in clinically insignificant extension of surgery to find anot…
- Pneumatic Tourniquet
- Under Investigation by firm
Zimmer Surgical IncOHJul 8, 2026
Class IIOngoingZ-2672-2026
W L Gore & Associates, Inc. recalls GORE¿ TAG¿ Thoracic Branch Endoprosthesis Side Branch Component Catalog Numbers (by Re…
Due to catheter separation
- Aortic Aneurysm Treatment Endovascular Graft System
- Under Investigation by firm
W L Gore & Associates,…AZJul 8, 2026