510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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Z-1492-2026Class II

Gelsoft Plus, REF: 635024PE, 631514PE, 631222PE, 633008PE, 633010PE, 633007PE, 636010PE, 632522PE, 633012PE...

Vascutek, Ltd. / initiated 2025-12-18 / Open, Classified / root cause: labeling and UDI
FDA source (opens on fda.gov)

Vascutek, Ltd. began a recall of Gelsoft Plus, REF: 635024PE, 631514PE, 631222PE, 633008PE, 633010PE, 633007PE, 636010PE, 632522PE, 633012PE, 635018PE, 631516PE, 636016PE, 631220PE, 631608PE... on . FDA classified it as Class II and gives the reason as "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...". As of , the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number
Z-1492-2026
Classification
Class II
Status
Open, Classified
Initiated
Posted
Recalling firm
Vascutek, Ltd.
Product
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,
Product code
DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
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 tag
labeling and UDI
FDA root cause
Error in labeling
Action
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.
Quantity in commerce
37430
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 codes and lots
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.

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1492-2026
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1492-2026Class IIOngoingVoluntary: Firm initiated