CLASS II ONGOING Device recall · Reported 3 Sep 2025 · FDA Enforcement Report

BD PhaSeal Injector Luer (N30C) recalled by Bd Switzerland Sarl

BD Switzerland Sarl is recalling BD PhaSeal Injector Luer (N30C), distributed nationwide in the US. The recall was initiated on 16 Jun 2025 and the FDA has classified it as Class II.

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Lot, batch or date codesREF/UDI-DI/Lot(Expiration): 515001/00382905150012. 515003/00382905150036/2402001(31-Jul-26), 2403002(31-Aug-26), 2403003(31-Aug-26), 2404006(30-Sep-26), 2405007(31-Oct-26), 2405014(31-Oct-26), 2408005(31-Jan-27), 2408006(31-Jan-27), 2409005(28-Feb-27), 2403713(31-Aug-26), 2404001(30-Sep-26), 2404002(30-Sep-26), 2404003(30-Sep-26), 2404004(30-Sep-26), 2404005(30-Sep-26), 2410001(31-Mar-27), 2410002(31-Mar-27), 2411001(30-Apr-27), 2411002(30-Apr-27), 2411003(30-Apr-27), 2411709(30-Apr-27), 2412002(31-May-27), 2501001(30-Jun-27), 2501002(30-Jun-27), 2501003(30-Jun-27), 2502001(31-Jul-27), 2502002(31-Jul-27), 2405004(31-Oct-26), 2405008(31-Oct-26), 2407001(31-Dec-26), 2412001(31-May-27), 2503001(31-Aug-27), 2503002(31-Aug-27), 2503003(31-Aug-27), 2504001(30-Sep-27), 2504002(30-Sep-27), 2504003(30-Sep-27); 515004/00382905150043/2405001(31-Oct-26), 2408018(31-Jan-27), 2411708(30-Apr-27), 2411727(30-Apr-27); 515005/00382905150050/2403006(31-Aug-26), 2404008(30-Sep-26), 2404009(30-Sep-26), 2404010(30-Sep-26), 2404011(30-Sep-26), 2404012(30-Sep-26), 2405002(31-Oct-26), 2407010(31-Dec-26), 2409011(28-Feb-27), 2409012(28-Feb-27), 2409016(28-Feb-27), 2410007(31-Mar-27), 2410008(31-Mar-27), 2410010(31-Mar-27), 2411725(30-Apr-27), 2405003(31-Oct-26), 2407011(31-Dec-26), 2407012(31-Dec-26), 2408008(31-Jan-27), 2408009(31-Jan-27), 2409007(28-Feb-27), 2409008(28-Feb-27), 2409009(28-Feb-27), 2409010(28-Feb-27), 2501006(30-Jun-27), 2503738(31-Aug-27), 2504004(30-Sep-27); 515100/00382905151002/2504117(31-Mar-30), 2404103(31-Mar-29), 2404122(31-Mar-29), 2404123(31-Mar-29), 2406112(31-May-29), 2406113(31-May-29), 2404124(31-Mar-29), 2405130(30-Apr-29), 2407112(30-Jun-29), 2409113(31-Aug-29), 2410113(30-Sep-29), 2410114(30-Sep-29), 2411115(31-Oct-29), 2412109(30-Nov-29), 2502116(31-Jan-30), 2503112(28-Feb-30); 515102/00382905151026/2403101(28-Feb-29), 2403102(28-Feb-29), 2403103(28-Feb-29), 2403104(28-Feb-29), 2403141(28-Feb-29), 2403707(28-Feb-29), 2404130(31-Mar-29), 2404131(31-Mar-29), 2404132(31-Mar-29), 2404141(31-Mar-29), 2404143(31-Mar-29), 2409601(31-Aug-29), 2403140(28-Feb-29), 2404125(31-Mar-29), 2404126(31-Mar-29), 2404127(31-Mar-29), 2404128(31-Mar-29), 2404129(31-Mar-29), 2404142(31-Mar-29), 2409108(31-Aug-29), 2409109(31-Aug-29), 2410701(30-Sep-29), 2412108(30-Nov-29), 2412114(30-Nov-29), 2501101(31-Dec-29), 2501102(31-Dec-29), 2501103(31-Dec-29), 2501104(31-Dec-29), 2501105(31-Dec-29), 2504108(31-Mar-30), 2504109(31-Mar-30), 2504119(31-Mar-30. 515103/00382905151033/2404133(31-Mar-29), 2404134(31-Mar-29), 2404140(31-Mar-29), 2410101(30-Sep-29), 2410102(30-Sep-29), 2410103(30-Sep-29), 2410104(30-Sep-29), 2504111(31-Mar-30). 515104/00382905151040/2410119(30-Sep-29), 2410107(30-Sep-29). 515105/00382905151057/2402112(31-Jan-29), 2403122(28-Feb-29), 2403123(28-Feb-29), 2403124(28-Feb-29), 2403125(28-Feb-29), 2403127(28-Feb-29), 2404113(31-Mar-29), 2404115(31-Mar-29), 2404117(31-Mar-29), 2405101(30-Apr-29), 2405102(30-Apr-29), 2405106(30-Apr-29), 2405107(30-Apr-29), 2405108(30-Apr-29), 2405152(30-Apr-29), 2406104(31-May-29), 2406105(31-May-29), 2406106(31-May-29), 2406107(31-May-29), 2406109(31-May-29), 2407103(30-Jun-29), 2407104(30-Jun-29), 2407106(30-Jun-29), 2407107(30-Jun-29), 2407108(30-Jun-29), 2407109(30-Jun-29), 2409103(31-Aug-29), 2409602(31-Aug-29), 2411123(31-Oct-29), 2411125(31-Oct-29), 2411126(31-Oct-29), 2411707(31-Oct-29), 2412105(30-Nov-29), 2403126(28-Feb-29), 2404102(31-Mar-29), 2404110(31-Mar-29), 2404111(31-Mar-29), 2404112(31-Mar-29), 2404114(31-Mar-29), 2404116(31-Mar-29), 2404118(31-Mar-29), 2404119(31-Mar-29), 2405103(30-Apr-29), 2405104(30-Apr-29), 2405105(30-Apr-29), 2407102(30-Jun-29), 2407105(30-Jun-29), 2409104(31-Aug-29), 2409105(31-Aug-29), 2411113(31-Oct-29), 2411124(31-Oct-29), 2501112(31-Dec-29), 2501113(31-Dec-29), 2501114(31-Dec-29), 2501115(31-Dec-29), 2502106(31-Jan-30), 2502107(31-Jan-30), 2501111(31-Dec-29), 2502108(31-Jan-30), 2502109(31-Jan-30), 2502110(31-Jan-30), 2502111(31-Jan-30), 2502112(31-Jan-30), 2503101(28-Feb-30), 2503102(28-Feb-30), 2503103(28-Feb-30), 2503801(28-Feb-30), 2504101(31-Mar-30), 2504102(31-Mar-30), 2504103(31-Mar-30), 2504104(31-Mar-30), 2504105(31-Mar-30), 2504106(31-Mar-30). 515106/00382905151064/2403109(28-Feb-29), 2403110(28-Feb-29), 2403111(28-Feb-29), 2403112(28-Feb-29), 2403113(28-Feb-29), 2403114(28-Feb-29), 2403115(28-Feb-29), 2403116(28-Feb-29), 2403117(28-Feb-29), 2403118(28-Feb-29), 2403119(28-Feb-29), 2403120(28-Feb-29), 2403121(28-Feb-29), 2404101(31-Mar-29), 2404104(31-Mar-29), 2404105(31-Mar-29), 2404106(31-Mar-29), 2404107(31-Mar-29), 2404108(31-Mar-29), 2405119(30-Apr-29), 2405120(30-Apr-29), 2405121(30-Apr-29), 2405122(30-Apr-29), 2405123(30-Apr-29), 2405124(30-Apr-29), 2405125(30-Apr-29), 2405126(30-Apr-29), 2405127(30-Apr-29), 2405128(30-Apr-29), 2405129(30-Apr-29), 2406101(31-May-29), 2406102(31-May-29), 2406103(31-May-29), 2407101(30-Jun-29), 2408101(31-Jul-29), 2409102(31-Aug-29), 2410110(30-Sep-29), 2409101(31-Aug-29), 2410108(30-Sep-29), 2410109(30-Sep-29), 2411101(31-Oct-29), 2411102(31-Oct-29), 2411103(31-Oct-29), 2411104(31-Oct-29), 2412106(30-Nov-29), 2412107(30-Nov-29), 2501110(31-Dec-29), 2502102(31-Jan-30), 2502103(31-Jan-30), 2503107(28-Feb-30), 2503108(28-Feb-30), 2503118(28-Feb-30), 2503119(28-Feb-30), 2504107(31-Mar-30). 515107/00382905151071/2407115(30-Jun-29). 515117/00382905151170/2405131(30-Apr-29), 2405132(30-Apr-29), 2405133(30-Apr-29), 2405134(30-Apr-29), 2407113(30-Jun-29), 2407114(30-Jun-29), 2409115(31-Aug-29), 2409120(31-Aug-29), 2409121(31-Aug-29), 2409122(31-Aug-29), 2411117(31-Oct-29), 2503111(28-Feb-30), 2504115(31-Mar-30), 2504116(31-Mar-30). 515200/00382905152009/2403715(29-Feb-28), 2404208(31-Mar-28), 2405203(30-Apr-28), 2407204(30-Jun-28), 2409202(31-Aug-28), 2411202(31-Oct-28), 2501201(31-Dec-28), 2405204(30-Apr-28), 2407203(30-Jun-28), 2409201(31-Aug-28), 2410201(30-Sep-28), 2410202(30-Sep-28), 2411201(31-Oct-28), 2411203(31-Oct-28), 2501202(31-Dec-28), 2502201(31-Jan-29), 2503201(28-Feb-29), 2503202(28-Feb-29), 2504201(31-Mar-29), 2504202(31-Mar-29). 515202/00382905152023/2404207(31-Mar-28), 2404202(31-Mar-28), 2407201(30-Jun-28), 2412202(30-Nov-28), 2501222(31-Dec-28), 2503206(28-Feb-29), 2504203(31-Mar-29). 515304/00382905153044/2406206(30-Sep-26), 2412212(31-Jan-27), 2503802(30-Apr-27). 515305/00382905153051/2403220(29-Feb-28), 2405221(30-Apr-28), 2405222(30-Apr-28), 2409218(31-Aug-28), 2404201(31-Mar-28), 2404206(31-Mar-28), 2502215(31-Jan-29). 515306/00382905153068/2402228(31-Jan-29), 2404210(31-Mar-28), 2404211(31-Mar-28), 2404212(31-Mar-28), 2404213(31-Mar-28), 2404214(31-Mar-28), 2404215(31-Mar-28), 2404216(31-Mar-28), 2406204(31-May-28), 2410212(30-Sep-28), 2410213(30-Sep-28), 2412216(30-Nov-28), 2404209(31-Mar-28), 2405224(30-Apr-28), 2502213(31-Jan-29), 2502214(31-Jan-29), 2406202(31-May-28), 2406203(31-May-28), 2410217(30-Sep-28), 2411206(31-Oct-28), 2411207(31-Oct-28), 2411721(31-Oct-28), 2411722(31-Oct-28), 2411723(31-Oct-28), 2412205(30-Nov-28), 2412206(30-Nov-28), 2412217(30-Nov-28), 2501213(31-Dec-28), 2501214(31-Dec-28), 2503207(28-Feb-29), 2503208(28-Feb-29), 2503209(28-Feb-29), 2504204(31-Mar-29), 2504205(31-Mar-29), 2504206(31-Mar-29). 515307/00382905153075 2403714(29-Feb-28), 2502212(31-Jan-29), 2403601(28-Feb-26), 2405225(30-Apr-28), 2410216(30-Sep-28). 515404/00382905154041/2404203(31-Mar-29), 2409220(31-Aug-29), 2405201(30-Apr-29), 2405202(30-Apr-29), 2406205(31-May-29). 515406/00382905154065/2404217(31-Mar-29). 515052/00382905150524/2403303(31-Aug-26), 2403304(31-Aug-26), 2403306(31-Aug-26), 2403307(31-Aug-26), 2404301(30-Sep-26), 2406303(30-Nov-26), 2406702(30-Nov-26), 2406801(30-Nov-26), 2408305(31-Jan-27), 2409302(28-Feb-27), 2410304(31-Mar-27), 2410306(31-Mar-27), 2411301(30-Apr-27), 2411302(30-Apr-27), 2412305(31-May-27), 2501303(30-Jun-27), 2501304(30-Jun-27), 2501305(30-Jun-27), 2502303(31-Jul-27), 2502304(31-Jul-27), 2502305(31-Jul-27), 2503301(31-Aug-27), 2405301(31-Oct-26), 2405302(31-Oct-26), 2405303(31-Oct-26), 2406302(30-Nov-26), 2406310(30-Nov-26), 2406803(30-Nov-26), 2407301(31-Dec-26), 2407302(31-Dec-26), 2407303(31-Dec-26), 2408304(31-Jan-27), 2408306(31-Jan-27), 2408307(31-Jan-27), 2408308(31-Jan-27), 2409301(28-Feb-27), 2409303(28-Feb-27), 2409304(28-Feb-27), 2410305(31-Mar-27), 2410307(31-Mar-27), 2503716(31-Aug-27), 2503717(31-Aug-27), 2503721(31-Aug-27), 2503722(31-Aug-27), 2504303(30-Sep-27), 2504304(30-Sep-27), 2504305(30-Sep-27), 2504306(30-Sep-27), 2504307(30-Sep-27). 515053/00382905150531/2404302(30-Sep-26), 2404303(30-Sep-26), 2404304(30-Sep-26), 2409305(28-Feb-27), 2409306(28-Feb-27), 2409307(28-Feb-27), 2405304(31-Oct-26), 2405305(31-Oct-26), 2410308(31-Mar-27), 2412303(31-May-27), 2412304(31-May-27), 2501301(30-Jun-27), 2501302(30-Jun-27), 2406701(30-Nov-26), 2406703(30-Nov-26), 2407304(31-Dec-26), 2407305(31-Dec-26), 2407306(31-Dec-26), 2407307(31-Dec-26), 2407308(31-Dec-26), 2407802(31-Dec-26), 2408309(31-Jan-27), 2408310(31-Jan-27), 2411303(30-Apr-27), 2501601(30-Jun-27), 2502701(31-Jul-27), 2502702(31-Jul-27), 2502703(31-Jul-27), 2502704(31-Jul-27), 2503723(31-Aug-27), 2503724(31-Aug-27), 2503725(31-Aug-27), 2504308(30-Sep-27). 515056/00382905150562/2405306(31-Oct-26), 2405307(31-Oct-26), 2405308(31-Oct-26), 2405312(31-Oct-26), 2408301(31-Jan-27), 2406301(30-Nov-26), 2409310(28-Feb-27), 2410301(31-Mar-27), 2410303(31-Mar-27), 2411304(30-Apr-27), 2411305(30-Apr-27), 2412301(31-May-27), 2501306(30-Jun-27), 2501307(30-Jun-27), 2501308(30-Jun-27), 2502301(31-Jul-27), 2502302(31-Jul-27), 2407309(31-Dec-26), 2407310(31-Dec-26), 2408302(31-Jan-27), 2409309(28-Feb-27), 2410302(31-Mar-27), 2410309(31-Mar-27), 2411306(30-Apr-27), 2503736(31-Aug-27), 2503737(31-Aug-27), 2504301(30-Sep-27), 2504801(30-Sep-27). 515057/00382905150579/2405311(31-Oct-26), 2409308(28-Feb-27), 2411308(30-Apr-27), 2412302(31-May-27), 2501309(30-Jun-27), 2501310(30-Jun-27), 2408303(31-Jan-27), 2411307(30-Apr-27), 2504302(30-Sep-27). 515060/00382905150609/2403413(28-Feb-26), 2403415(28-Feb-26), 2404408(31-Mar-26), 2404409(31-Mar-26), 2405409(30-Apr-26), 2405410(30-Apr-26), 2405412(30-Apr-26), 2405413(30-Apr-26), 2405414(30-Apr-26), 2405415(30-Apr-26), 2406407(31-May-26), 2407805(30-Jun-26), 2407806(30-Jun-26), 2407807(30-Jun-26), 2403414(28-Feb-26), 2404407(31-Mar-26), 2404410(31-Mar-26), 2405411(30-Apr-26), 2407803(30-Jun-26), 2407804(30-Jun-26), 2408406(31-Jul-26), 2408407(31-Jul-26), 2408408(31-Jul-26), 2409411(31-Aug-26), 2409413(31-Aug-26), 2410402(30-Sep-26), 2410408(30-Sep-26), 2410409(30-Sep-26), 2410410(30-Sep-26), 2410416(30-Sep-26), 2410417(30-Sep-26), 2410602(30-Sep-26), 2411413(31-Oct-26), 2411414(31-Oct-26), 2412407(30-Nov-26), 2412408(30-Nov-26), 2412409(30-Nov-26), 2412410(30-Nov-26), 2412411(30-Nov-26), 2412701(30-Nov-26), 2501406(31-Dec-26), 2409412(31-Aug-26), 2409414(31-Aug-26), 2409415(31-Aug-26), 2409416(31-Aug-26), 2412412(30-Nov-26), 2412414(30-Nov-26), 2501407(31-Dec-26), 2501408(31-Dec-26), 2504409(31-Mar-27). 515062/00382905150623. 515063/00382905150630/2502706(31-Mar-27), 2502705(31-Mar-27). 515064/00382905150647/2402405(31-Jan-26), 2403401(28-Feb-26), 2403404(28-Feb-26), 2403405(28-Feb-26), 2403408(28-Feb-26), 2403409(28-Feb-26), 2403410(28-Feb-26), 2403411(28-Feb-26), 2403412(28-Feb-26), 2403703(28-Feb-26), 2403704(28-Feb-26), 2404403(31-Mar-26), 2404404(31-Mar-26), 2404405(31-Mar-26), 2404411(31-Mar-26), 2404412(31-Mar-26), 2404416(31-Mar-26), 2405401(30-Apr-26), 2405403(30-Apr-26), 2405407(30-Apr-26), 2405408(30-Apr-26), 2405417(30-Apr-26), 2406402(31-May-26), 2406403(31-May-26), 2406404(31-May-26), 2406411(31-May-26), 2406412(31-May-26), 2406413(31-May-26), 2406414(31-May-26), 2406415(31-May-26), 2406416(31-May-26), 2407402(30-Jun-26), 2407403(30-Jun-26), 2407404(30-Jun-26), 2408410(31-Jul-26), 2408413(31-Jul-26), 2408414(31-Jul-26), 2405402(30-Apr-26), 2407415(30-Jun-26), 2408403(31-Jul-26), 2408404(31-Jul-26), 2408411(31-Jul-26), 2408412(31-Jul-26), 2409401(31-Aug-26), 2409402(31-Aug-26), 2409403(31-Aug-26), 2409405(31-Aug-26), 2411403(31-Oct-26), 2411404(31-Oct-26), 2411411(31-Oct-26), 2411412(31-Oct-26), 2412401(30-Nov-26), 2412402(30-Nov-26), 2412403(30-Nov-26), 2501403(31-Dec-26), 2501404(31-Dec-26), 2501415(31-Dec-26), 2501416(31-Dec-26), 2502401(31-Jan-27), 2502403(31-Jan-27), 2502404(31-Jan-27), 2502408(31-Jan-27), 2502410(31-Jan-27), 2502707(31-Jan-27), 2410403(30-Sep-26), 2410407(30-Sep-26), 2410413(30-Sep-26), 2410419(30-Sep-26), 2410420(30-Sep-26), 2410601(30-Sep-26), 2411410(31-Oct-26), 2501405(31-Dec-26), 2502708(31-Jan-27), 2502709(31-Jan-27), 2503703(28-Feb-27), 2503705(28-Feb-27), 2503706(28-Feb-27), 2503707(28-Feb-27), 2503708(28-Feb-27), 2504405(31-Mar-27), 2504406(31-Mar-27), 2504407(31-Mar-27), 2504408(31-Mar-27), 2505404(31-Mar-27). 515065/00382905150654/2402404(31-Jan-26), 2402411(31-Jan-26), 2402412(31-Jan-26), 2403403(28-Feb-26), 2403406(28-Feb-26), 2403416(28-Feb-26), 2403417(28-Feb-26), 2404401(31-Mar-26), 2404402(31-Mar-26), 2404406(31-Mar-26), 2405404(30-Apr-26), 2405405(30-Apr-26), 2405406(30-Apr-26), 2406401(31-May-26), 2406405(31-May-26), 2406406(31-May-26), 2406408(31-May-26), 2406409(31-May-26), 2406410(31-May-26), 2407401(30-Jun-26), 2407405(30-Jun-26), 2407406(30-Jun-26), 2407407(30-Jun-26), 2407408(30-Jun-26), 2407409(30-Jun-26), 2407416(30-Jun-26), 2407417(30-Jun-26), 2408401(31-Jul-26), 2408405(31-Jul-26), 2408417(31-Jul-26), 2409404(31-Aug-26), 2409407(31-Aug-26), 2409408(31-Aug-26), 2404417(31-Mar-26), 2408402(31-Jul-26), 2409406(31-Aug-26), 2410406(30-Sep-26), 2411401(31-Oct-26), 2411402(31-Oct-26), 2411418(31-Oct-26), 2412404(30-Nov-26), 2501401(31-Dec-26), 2501413(31-Dec-26), 2501418(31-Dec-26), 2410401(30-Sep-26), 2502405(31-Jan-27), 2410404(30-Sep-26), 2410405(30-Sep-26), 2502409(31-Jan-27), 2502415(31-Jan-27), 2410414(30-Sep-26), 2410415(30-Sep-26), 2410418(30-Sep-26), 2412405(30-Nov-26), 2412601(30-Nov-26), 2501402(31-Dec-26), 2501414(31-Dec-26), 2501417(31-Dec-26), 2502402(31-Jan-27), 2502413(31-Jan-27), 2502414(31-Jan-27), 2503405(28-Feb-27), 2503601(28-Feb-27), 2503701(28-Feb-27), 2503702(28-Feb-27), 2503704(28-Feb-27), 2503709(28-Feb-27), 2503710(28-Feb-27), 2503711(28-Feb-27), 2503712(28-Feb-27), 2503713(28-Feb-27), 2503715(28-Feb-27), 2503741(28-Feb-27), 2503742(28-Feb-27), 2504403(31-Mar-27), 2504404(31-Mar-27), 2504601(31-Mar-27), 2504701(31-Mar-27), 2504702(31-Mar-27). 515070/00382905150708/2403701(28-Feb-26), 2403705(28-Feb-26), 2404507(31-Mar-26), 2404508(31-Mar-26), 2404509(31-Mar-26), 2405505(30-Apr-26), 2405506(30-Apr-26), 2406507(31-May-26), 2407506(30-Jun-26), 2407507(30-Jun-26), 2404506(31-Mar-26), 2406508(31-May-26), 2409501(31-Aug-26), 2409502(31-Aug-26), 2409506(31-Aug-26), 2410505(30-Sep-26), 2410506(30-Sep-26), 2411503(31-Oct-26), 2411504(31-Oct-26), 2412503(30-Nov-26), 2412504(30-Nov-26), 2501506(31-Dec-26), 2501507(31-Dec-26), 2501508(31-Dec-26), 2502501(31-Jan-27), 2501518(31-Dec-26), 2502502(31-Jan-27), 2503726(28-Feb-27), 2503727(28-Feb-27), 2504501(31-Mar-27), 2504502(31-Mar-27), 2504503(31-Mar-27). 515078/00382905150784/2402505(31-Jan-26), 2403505(28-Feb-26), 2403507(28-Feb-26), 2404501(31-Mar-26), 2404502(31-Mar-26), 2405501(30-Apr-26), 2405502(30-Apr-26), 2405503(30-Apr-26), 2405504(30-Apr-26), 2406504(31-May-26), 2406505(31-May-26), 2406506(31-May-26), 2407501(30-Jun-26), 2407502(30-Jun-26), 2407801(30-Jun-26), 2403504(28-Feb-26), 2404505(31-Mar-26), 2408501(31-Jul-26), 2409504(31-Aug-26), 2409505(31-Aug-26), 2410501(30-Sep-26), 2410502(30-Sep-26), 2410507(30-Sep-26), 2411501(31-Oct-26), 2411502(31-Oct-26), 2411508(31-Oct-26), 2412502(30-Nov-26), 2501501(31-Dec-26), 2501502(31-Dec-26), 2501503(31-Dec-26), 2502505(31-Jan-27), 2502506(31-Jan-27), 2502507(31-Jan-27), 2503728(28-Feb-27), 2504506(31-Mar-27), 2504507(31-Mar-27). 515079/00382905150791/2402601(31-Jan-26), 2403702(28-Feb-26), 2403706(28-Feb-26), 2404503(31-Mar-26), 2406501(31-May-26), 2406502(31-May-26), 2406503(31-May-26), 2408502(31-Jul-26), 2408503(31-Jul-26), 2408504(31-Jul-26), 2408505(31-Jul-26), 2410503(30-Sep-26), 2410504(30-Sep-26), 2403508(28-Feb-26), 2409503(31-Aug-26), 2411506(31-Oct-26), 2411507(31-Oct-26), 2412501(30-Nov-26), 2501504(31-Dec-26), 2501505(31-Dec-26), 2502503(31-Jan-27), 2502504(31-Jan-27), 2503504(28-Feb-27), 2503505(28-Feb-27), 2503506(28-Feb-27), 2504504(31-Mar-27), 2504505(31-Mar-27).

Quantity recalled3,884,670

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2453-2025
FDA event ID: 97070
Recalling firm: BD Switzerland Sarl, Eysins
Classification: Class II
Status: Ongoing
Recall initiated: 16 Jun 2025
FDA classified: 27 Aug 2025
Reported: 3 Sep 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

16 Jun 2025	Recall initiated by company
27 Aug 2025	Classified by FDA	+72 days
3 Sep 2025	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Closed system drug transfer devices were shipped to the U.S. market without a U.S. version of the instructions for use, which could be an issue if a healthcare professional is prompted to review it.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

BD PhaSeal Injector Luer (N30C), REF: 515001 BD PhaSeal Injector Luer Lock (N35), REF: 515003 BD PhaSeal Injector Luer Lock (N35C), REF: 515004 BD PhaSeal Injector Lu63er Lock (N35C Multi), REF: 515005 BD PhaSeal Protector (P14), REF: 515100 BD PhaSeal Protector (P21), REF: 515102 BD PhaSeal Protector (P21 Multi), REF: 515103 BD PhaSeal Protector (P28), REF: 515104 BD PhaSeal Protector (P50), REF: 515105 BD PhaSeal Protector (P50 Multi), REF: 515106 BD PhaSeal Protector (P53), REF: 515107 BD PhaSeal Protector (P55), REF: 515117 BD PhaSeal Connector Luer Lock (C35), REF: 515200 BD PhaSeal Connector Luer Lock (C45), REF: 515202 BD PhaSeal Y-site Connector (C80), REF: 515304 BD PhaSeal L Connector (C90), REF: 515305 BD PhaSeal Infusion Adapter (C100), REF: 515306 BD PhaSeal Infusion Adapter (C100 Multi), REF: 515307 BD PhaSeal Cap for Injector (M50), REF: 515404 BD PhaSeal Connector Cap (M70), REF: 515406 BD PhaSeal Optima Injector (N35-O), REF: 515052 BD PhaSeal Optima Injector (N35-O Multi), REF: 515053 BD PhaSeal Injector Locking (N40-O), REF: 515056 BD PhaSeal Injector Locking (N40-O Multi), REF: 515057 BD PhaSeal Optima Protector (P13-O), REF: 515060 BD PhaSeal Optima Protector (P13-O Multi), REF: 515062 BD PhaSeal Optima Protector (P28-O), REF: 515063 BD PhaSeal Optima Protector (P20-O), REF: 515064 BD PhaSeal Optima Protector (P20-O Multi), REF: 515065 BD PhaSeal Optima Connector (C35-O), REF: 515070 BD PhaSeal Optima Infusion Adapter (C100-O), 515078 BD PhaSeal Optima Infusion Adapter (C100-O Multi), REF: 515079

Where it was distributed

US Nationwide distribution including in the states of CA, WA, AL, OH, NC, GA, MA, IL, MO, AZ, PA, MS, MN, MI, TX, VA, IN, NV, CO, FL, WV, WI, NY, NJ, UT, MD, MT, NM, TN, HI, OK, OR, AK, DC, IA, LA, ME, SC.

Nationwide Alaska Alabama Arizona California Colorado District of Columbia Florida Georgia Hawaii Iowa Illinois Indiana Louisiana Massachusetts Maryland Maine Michigan Minnesota Missouri Mississippi

Questions about this recall

Why was it recalled?

Closed system drug transfer devices were shipped to the U.S. market without a U.S. version of the instructions for use, which could be an issue if a healthcare professional is prompted to review it.

Which lots are affected?

REF/UDI-DI/Lot(Expiration): 515001/00382905150012. 515003/00382905150036/2402001(31-Jul-26), 2403002(31-Aug-26), 2403003(31-Aug-26), 2404006(30-Sep-26), 2405007(31-Oct-26), 2405014(31-Oct-26), 2408005(31-Jan-27), 2408006(31-Jan-27), 2409005(28-Feb-27), 2403713(31-Aug-26), 2404001(30-Sep-26), 2404002(30-Sep-26), 2404003(30-Sep-26), 2404004(30-Sep-26), 2404005(30-Sep-26), 2410001(31-Mar-27), 2410002(31-Mar-27), 2411001(30-Apr-27), 2411002(30-Apr-27), 2411003(30-Apr-27), 2411709(30-Apr-27), 2412002(31-May-27), 2501001(30-Jun-27), 2501002(30-Jun-27), 2501003(30-Jun-27), 2502001(31-Jul-27), 2502002(31-Jul-27), 2405004(31-Oct-26), 2405008(31-Oct-26), 2407001(31-Dec-26), 2412001(31-May-27), 2503001(31-Aug-27), 2503002(31-Aug-27), 2503003(31-Aug-27), 2504001(30-Sep-27), 2504002(30-Sep-27), 2504003(30-Sep-27); 515004/00382905150043/2405001(31-Oct-26), 2408018(31-Jan-27), 2411708(30-Apr-27), 2411727(30-Apr-27); 515005/00382905150050/2403006(31-Aug-26), 2404008(30-Sep-26), 2404009(30-Sep-26), 2404010(30-Sep-26), 2404011(30-Sep-26), 2404012(30-Sep-26), 2405002(31-Oct-26), 2407010(31-Dec-26), 2409011(28-Feb-27), 2409012(28-Feb-27), 2409016(28-Feb-27), 2410007(31-Mar-27), 2410008(31-Mar-27), 2410010(31-Mar-27), 2411725(30-Apr-27), 2405003(31-Oct-26), 2407011(31-Dec-26), 2407012(31-Dec-26), 2408008(31-Jan-27), 2408009(31-Jan-27), 2409007(28-Feb-27), 2409008(28-Feb-27), 2409009(28-Feb-27), 2409010(28-Feb-27), 2501006(30-Jun-27), 2503738(31-Aug-27), 2504004(30-Sep-27); 515100/00382905151002/2504117(31-Mar-30), 2404103(31-Mar-29), 2404122(31-Mar-29), 2404123(31-Mar-29), 2406112(31-May-29), 2406113(31-May-29), 2404124(31-Mar-29), 2405130(30-Apr-29), 2407112(30-Jun-29), 2409113(31-Aug-29), 2410113(30-Sep-29), 2410114(30-Sep-29), 2411115(31-Oct-29), 2412109(30-Nov-29), 2502116(31-Jan-30), 2503112(28-Feb-30); 515102/00382905151026/2403101(28-Feb-29), 2403102(28-Feb-29), 2403103(28-Feb-29), 2403104(28-Feb-29), 2403141(28-Feb-29), 2403707(28-Feb-29), 2404130(31-Mar-29), 2404131(31-Mar-29), 2404132(31-Mar-29), 2404141(31-Mar-29), 2404143(31-Mar-29), 2409601(31-Aug-29), 2403140(28-Feb-29), 2404125(31-Mar-29), 2404126(31-Mar-29), 2404127(31-Mar-29), 2404128(31-Mar-29), 2404129(31-Mar-29), 2404142(31-Mar-29), 2409108(31-Aug-29), 2409109(31-Aug-29), 2410701(30-Sep-29), 2412108(30-Nov-29), 2412114(30-Nov-29), 2501101(31-Dec-29), 2501102(31-Dec-29), 2501103(31-Dec-29), 2501104(31-Dec-29), 2501105(31-Dec-29), 2504108(31-Mar-30), 2504109(31-Mar-30), 2504119(31-Mar-30. 515103/00382905151033/2404133(31-Mar-29), 2404134(31-Mar-29), 2404140(31-Mar-29), 2410101(30-Sep-29), 2410102(30-Sep-29), 2410103(30-Sep-29), 2410104(30-Sep-29), 2504111(31-Mar-30). 515104/00382905151040/2410119(30-Sep-29), 2410107(30-Sep-29). 515105/00382905151057/2402112(31-Jan-29), 2403122(28-Feb-29), 2403123(28-Feb-29), 2403124(28-Feb-29), 2403125(28-Feb-29), 2403127(28-Feb-29), 2404113(31-Mar-29), 2404115(31-Mar-29), 2404117(31-Mar-29), 2405101(30-Apr-29), 2405102(30-Apr-29), 2405106(30-Apr-29), 2405107(30-Apr-29), 2405108(30-Apr-29), 2405152(30-Apr-29), 2406104(31-May-29), 2406105(31-May-29), 2406106(31-May-29), 2406107(31-May-29), 2406109(31-May-29), 2407103(30-Jun-29), 2407104(30-Jun-29), 2407106(30-Jun-29), 2407107(30-Jun-29), 2407108(30-Jun-29), 2407109(30-Jun-29), 2409103(31-Aug-29), 2409602(31-Aug-29), 2411123(31-Oct-29), 2411125(31-Oct-29), 2411126(31-Oct-29), 2411707(31-Oct-29), 2412105(30-Nov-29), 2403126(28-Feb-29), 2404102(31-Mar-29), 2404110(31-Mar-29), 2404111(31-Mar-29), 2404112(31-Mar-29), 2404114(31-Mar-29), 2404116(31-Mar-29), 2404118(31-Mar-29), 2404119(31-Mar-29), 2405103(30-Apr-29), 2405104(30-Apr-29), 2405105(30-Apr-29), 2407102(30-Jun-29), 2407105(30-Jun-29), 2409104(31-Aug-29), 2409105(31-Aug-29), 2411113(31-Oct-29), 2411124(31-Oct-29), 2501112(31-Dec-29), 2501113(31-Dec-29), 2501114(31-Dec-29), 2501115(31-Dec-29), 2502106(31-Jan-30), 2502107(31-Jan-30), 2501111(31-Dec-29), 2502108(31-Jan-30), 2502109(31-Jan-30), 2502110(31-Jan-30), 2502111(31-Jan-30), 2502112(31-Jan-30), 2503101(28-Feb-30), 2503102(28-Feb-30), 2503103(28-Feb-30), 2503801(28-Feb-30), 2504101(31-Mar-30), 2504102(31-Mar-30), 2504103(31-Mar-30), 2504104(31-Mar-30), 2504105(31-Mar-30), 2504106(31-Mar-30). 515106/00382905151064/2403109(28-Feb-29), 2403110(28-Feb-29), 2403111(28-Feb-29), 2403112(28-Feb-29), 2403113(28-Feb-29), 2403114(28-Feb-29), 2403115(28-Feb-29), 2403116(28-Feb-29), 2403117(28-Feb-29), 2403118(28-Feb-29), 2403119(28-Feb-29), 2403120(28-Feb-29), 2403121(28-Feb-29), 2404101(31-Mar-29), 2404104(31-Mar-29), 2404105(31-Mar-29), 2404106(31-Mar-29), 2404107(31-Mar-29), 2404108(31-Mar-29), 2405119(30-Apr-29), 2405120(30-Apr-29), 2405121(30-Apr-29), 2405122(30-Apr-29), 2405123(30-Apr-29), 2405124(30-Apr-29), 2405125(30-Apr-29), 2405126(30-Apr-29), 2405127(30-Apr-29), 2405128(30-Apr-29), 2405129(30-Apr-29), 2406101(31-May-29), 2406102(31-May-29), 2406103(31-May-29), 2407101(30-Jun-29), 2408101(31-Jul-29), 2409102(31-Aug-29), 2410110(30-Sep-29), 2409101(31-Aug-29), 2410108(30-Sep-29), 2410109(30-Sep-29), 2411101(31-Oct-29), 2411102(31-Oct-29), 2411103(31-Oct-29), 2411104(31-Oct-29), 2412106(30-Nov-29), 2412107(30-Nov-29), 2501110(31-Dec-29), 2502102(31-Jan-30), 2502103(31-Jan-30), 2503107(28-Feb-30), 2503108(28-Feb-30), 2503118(28-Feb-30), 2503119(28-Feb-30), 2504107(31-Mar-30). 515107/00382905151071/2407115(30-Jun-29). 515117/00382905151170/2405131(30-Apr-29), 2405132(30-Apr-29), 2405133(30-Apr-29), 2405134(30-Apr-29), 2407113(30-Jun-29), 2407114(30-Jun-29), 2409115(31-Aug-29), 2409120(31-Aug-29), 2409121(31-Aug-29), 2409122(31-Aug-29), 2411117(31-Oct-29), 2503111(28-Feb-30), 2504115(31-Mar-30), 2504116(31-Mar-30). 515200/00382905152009/2403715(29-Feb-28), 2404208(31-Mar-28), 2405203(30-Apr-28), 2407204(30-Jun-28), 2409202(31-Aug-28), 2411202(31-Oct-28), 2501201(31-Dec-28), 2405204(30-Apr-28), 2407203(30-Jun-28), 2409201(31-Aug-28), 2410201(30-Sep-28), 2410202(30-Sep-28), 2411201(31-Oct-28), 2411203(31-Oct-28), 2501202(31-Dec-28), 2502201(31-Jan-29), 2503201(28-Feb-29), 2503202(28-Feb-29), 2504201(31-Mar-29), 2504202(31-Mar-29). 515202/00382905152023/2404207(31-Mar-28), 2404202(31-Mar-28), 2407201(30-Jun-28), 2412202(30-Nov-28), 2501222(31-Dec-28), 2503206(28-Feb-29), 2504203(31-Mar-29). 515304/00382905153044/2406206(30-Sep-26), 2412212(31-Jan-27), 2503802(30-Apr-27). 515305/00382905153051/2403220(29-Feb-28), 2405221(30-Apr-28), 2405222(30-Apr-28), 2409218(31-Aug-28), 2404201(31-Mar-28), 2404206(31-Mar-28), 2502215(31-Jan-29). 515306/00382905153068/2402228(31-Jan-29), 2404210(31-Mar-28), 2404211(31-Mar-28), 2404212(31-Mar-28), 2404213(31-Mar-28), 2404214(31-Mar-28), 2404215(31-Mar-28), 2404216(31-Mar-28), 2406204(31-May-28), 2410212(30-Sep-28), 2410213(30-Sep-28), 2412216(30-Nov-28), 2404209(31-Mar-28), 2405224(30-Apr-28), 2502213(31-Jan-29), 2502214(31-Jan-29), 2406202(31-May-28), 2406203(31-May-28), 2410217(30-Sep-28), 2411206(31-Oct-28), 2411207(31-Oct-28), 2411721(31-Oct-28), 2411722(31-Oct-28), 2411723(31-Oct-28), 2412205(30-Nov-28), 2412206(30-Nov-28), 2412217(30-Nov-28), 2501213(31-Dec-28), 2501214(31-Dec-28), 2503207(28-Feb-29), 2503208(28-Feb-29), 2503209(28-Feb-29), 2504204(31-Mar-29), 2504205(31-Mar-29), 2504206(31-Mar-29). 515307/00382905153075 2403714(29-Feb-28), 2502212(31-Jan-29), 2403601(28-Feb-26), 2405225(30-Apr-28), 2410216(30-Sep-28). 515404/00382905154041/2404203(31-Mar-29), 2409220(31-Aug-29), 2405201(30-Apr-29), 2405202(30-Apr-29), 2406205(31-May-29). 515406/00382905154065/2404217(31-Mar-29). 515052/00382905150524/2403303(31-Aug-26), 2403304(31-Aug-26), 2403306(31-Aug-26), 2403307(31-Aug-26), 2404301(30-Sep-26), 2406303(30-Nov-26), 2406702(30-Nov-26), 2406801(30-Nov-26), 2408305(31-Jan-27), 2409302(28-Feb-27), 2410304(31-Mar-27), 2410306(31-Mar-27), 2411301(30-Apr-27), 2411302(30-Apr-27), 2412305(31-May-27), 2501303(30-Jun-27), 2501304(30-Jun-27), 2501305(30-Jun-27), 2502303(31-Jul-27), 2502304(31-Jul-27), 2502305(31-Jul-27), 2503301(31-Aug-27), 2405301(31-Oct-26), 2405302(31-Oct-26), 2405303(31-Oct-26), 2406302(30-Nov-26), 2406310(30-Nov-26), 2406803(30-Nov-26), 2407301(31-Dec-26), 2407302(31-Dec-26), 2407303(31-Dec-26), 2408304(31-Jan-27), 2408306(31-Jan-27), 2408307(31-Jan-27), 2408308(31-Jan-27), 2409301(28-Feb-27), 2409303(28-Feb-27), 2409304(28-Feb-27), 2410305(31-Mar-27), 2410307(31-Mar-27), 2503716(31-Aug-27), 2503717(31-Aug-27), 2503721(31-Aug-27), 2503722(31-Aug-27), 2504303(30-Sep-27), 2504304(30-Sep-27), 2504305(30-Sep-27), 2504306(30-Sep-27), 2504307(30-Sep-27). 515053/00382905150531/2404302(30-Sep-26), 2404303(30-Sep-26), 2404304(30-Sep-26), 2409305(28-Feb-27), 2409306(28-Feb-27), 2409307(28-Feb-27), 2405304(31-Oct-26), 2405305(31-Oct-26), 2410308(31-Mar-27), 2412303(31-May-27), 2412304(31-May-27), 2501301(30-Jun-27), 2501302(30-Jun-27), 2406701(30-Nov-26), 2406703(30-Nov-26), 2407304(31-Dec-26), 2407305(31-Dec-26), 2407306(31-Dec-26), 2407307(31-Dec-26), 2407308(31-Dec-26), 2407802(31-Dec-26), 2408309(31-Jan-27), 2408310(31-Jan-27), 2411303(30-Apr-27), 2501601(30-Jun-27), 2502701(31-Jul-27), 2502702(31-Jul-27), 2502703(31-Jul-27), 2502704(31-Jul-27), 2503723(31-Aug-27), 2503724(31-Aug-27), 2503725(31-Aug-27), 2504308(30-Sep-27). 515056/00382905150562/2405306(31-Oct-26), 2405307(31-Oct-26), 2405308(31-Oct-26), 2405312(31-Oct-26), 2408301(31-Jan-27), 2406301(30-Nov-26), 2409310(28-Feb-27), 2410301(31-Mar-27), 2410303(31-Mar-27), 2411304(30-Apr-27), 2411305(30-Apr-27), 2412301(31-May-27), 2501306(30-Jun-27), 2501307(30-Jun-27), 2501308(30-Jun-27), 2502301(31-Jul-27), 2502302(31-Jul-27), 2407309(31-Dec-26), 2407310(31-Dec-26), 2408302(31-Jan-27), 2409309(28-Feb-27), 2410302(31-Mar-27), 2410309(31-Mar-27), 2411306(30-Apr-27), 2503736(31-Aug-27), 2503737(31-Aug-27), 2504301(30-Sep-27), 2504801(30-Sep-27). 515057/00382905150579/2405311(31-Oct-26), 2409308(28-Feb-27), 2411308(30-Apr-27), 2412302(31-May-27), 2501309(30-Jun-27), 2501310(30-Jun-27), 2408303(31-Jan-27), 2411307(30-Apr-27), 2504302(30-Sep-27). 515060/00382905150609/2403413(28-Feb-26), 2403415(28-Feb-26), 2404408(31-Mar-26), 2404409(31-Mar-26), 2405409(30-Apr-26), 2405410(30-Apr-26), 2405412(30-Apr-26), 2405413(30-Apr-26), 2405414(30-Apr-26), 2405415(30-Apr-26), 2406407(31-May-26), 2407805(30-Jun-26), 2407806(30-Jun-26), 2407807(30-Jun-26), 2403414(28-Feb-26), 2404407(31-Mar-26), 2404410(31-Mar-26), 2405411(30-Apr-26), 2407803(30-Jun-26), 2407804(30-Jun-26), 2408406(31-Jul-26), 2408407(31-Jul-26), 2408408(31-Jul-26), 2409411(31-Aug-26), 2409413(31-Aug-26), 2410402(30-Sep-26), 2410408(30-Sep-26), 2410409(30-Sep-26), 2410410(30-Sep-26), 2410416(30-Sep-26), 2410417(30-Sep-26), 2410602(30-Sep-26), 2411413(31-Oct-26), 2411414(31-Oct-26), 2412407(30-Nov-26), 2412408(30-Nov-26), 2412409(30-Nov-26), 2412410(30-Nov-26), 2412411(30-Nov-26), 2412701(30-Nov-26), 2501406(31-Dec-26), 2409412(31-Aug-26), 2409414(31-Aug-26), 2409415(31-Aug-26), 2409416(31-Aug-26), 2412412(30-Nov-26), 2412414(30-Nov-26), 2501407(31-Dec-26), 2501408(31-Dec-26), 2504409(31-Mar-27). 515062/00382905150623. 515063/00382905150630/2502706(31-Mar-27), 2502705(31-Mar-27). 515064/00382905150647/2402405(31-Jan-26), 2403401(28-Feb-26), 2403404(28-Feb-26), 2403405(28-Feb-26), 2403408(28-Feb-26), 2403409(28-Feb-26), 2403410(28-Feb-26), 2403411(28-Feb-26), 2403412(28-Feb-26), 2403703(28-Feb-26), 2403704(28-Feb-26), 2404403(31-Mar-26), 2404404(31-Mar-26), 2404405(31-Mar-26), 2404411(31-Mar-26), 2404412(31-Mar-26), 2404416(31-Mar-26), 2405401(30-Apr-26), 2405403(30-Apr-26), 2405407(30-Apr-26), 2405408(30-Apr-26), 2405417(30-Apr-26), 2406402(31-May-26), 2406403(31-May-26), 2406404(31-May-26), 2406411(31-May-26), 2406412(31-May-26), 2406413(31-May-26), 2406414(31-May-26), 2406415(31-May-26), 2406416(31-May-26), 2407402(30-Jun-26), 2407403(30-Jun-26), 2407404(30-Jun-26), 2408410(31-Jul-26), 2408413(31-Jul-26), 2408414(31-Jul-26), 2405402(30-Apr-26), 2407415(30-Jun-26), 2408403(31-Jul-26), 2408404(31-Jul-26), 2408411(31-Jul-26), 2408412(31-Jul-26), 2409401(31-Aug-26), 2409402(31-Aug-26), 2409403(31-Aug-26), 2409405(31-Aug-26), 2411403(31-Oct-26), 2411404(31-Oct-26), 2411411(31-Oct-26), 2411412(31-Oct-26), 2412401(30-Nov-26), 2412402(30-Nov-26), 2412403(30-Nov-26), 2501403(31-Dec-26), 2501404(31-Dec-26), 2501415(31-Dec-26), 2501416(31-Dec-26), 2502401(31-Jan-27), 2502403(31-Jan-27), 2502404(31-Jan-27), 2502408(31-Jan-27), 2502410(31-Jan-27), 2502707(31-Jan-27), 2410403(30-Sep-26), 2410407(30-Sep-26), 2410413(30-Sep-26), 2410419(30-Sep-26), 2410420(30-Sep-26), 2410601(30-Sep-26), 2411410(31-Oct-26), 2501405(31-Dec-26), 2502708(31-Jan-27), 2502709(31-Jan-27), 2503703(28-Feb-27), 2503705(28-Feb-27), 2503706(28-Feb-27), 2503707(28-Feb-27), 2503708(28-Feb-27), 2504405(31-Mar-27), 2504406(31-Mar-27), 2504407(31-Mar-27), 2504408(31-Mar-27), 2505404(31-Mar-27). 515065/00382905150654/2402404(31-Jan-26), 2402411(31-Jan-26), 2402412(31-Jan-26), 2403403(28-Feb-26), 2403406(28-Feb-26), 2403416(28-Feb-26), 2403417(28-Feb-26), 2404401(31-Mar-26), 2404402(31-Mar-26), 2404406(31-Mar-26), 2405404(30-Apr-26), 2405405(30-Apr-26), 2405406(30-Apr-26), 2406401(31-May-26), 2406405(31-May-26), 2406406(31-May-26), 2406408(31-May-26), 2406409(31-May-26), 2406410(31-May-26), 2407401(30-Jun-26), 2407405(30-Jun-26), 2407406(30-Jun-26), 2407407(30-Jun-26), 2407408(30-Jun-26), 2407409(30-Jun-26), 2407416(30-Jun-26), 2407417(30-Jun-26), 2408401(31-Jul-26), 2408405(31-Jul-26), 2408417(31-Jul-26), 2409404(31-Aug-26), 2409407(31-Aug-26), 2409408(31-Aug-26), 2404417(31-Mar-26), 2408402(31-Jul-26), 2409406(31-Aug-26), 2410406(30-Sep-26), 2411401(31-Oct-26), 2411402(31-Oct-26), 2411418(31-Oct-26), 2412404(30-Nov-26), 2501401(31-Dec-26), 2501413(31-Dec-26), 2501418(31-Dec-26), 2410401(30-Sep-26), 2502405(31-Jan-27), 2410404(30-Sep-26), 2410405(30-Sep-26), 2502409(31-Jan-27), 2502415(31-Jan-27), 2410414(30-Sep-26), 2410415(30-Sep-26), 2410418(30-Sep-26), 2412405(30-Nov-26), 2412601(30-Nov-26), 2501402(31-Dec-26), 2501414(31-Dec-26), 2501417(31-Dec-26), 2502402(31-Jan-27), 2502413(31-Jan-27), 2502414(31-Jan-27), 2503405(28-Feb-27), 2503601(28-Feb-27), 2503701(28-Feb-27), 2503702(28-Feb-27), 2503704(28-Feb-27), 2503709(28-Feb-27), 2503710(28-Feb-27), 2503711(28-Feb-27), 2503712(28-Feb-27), 2503713(28-Feb-27), 2503715(28-Feb-27), 2503741(28-Feb-27), 2503742(28-Feb-27), 2504403(31-Mar-27), 2504404(31-Mar-27), 2504601(31-Mar-27), 2504701(31-Mar-27), 2504702(31-Mar-27). 515070/00382905150708/2403701(28-Feb-26), 2403705(28-Feb-26), 2404507(31-Mar-26), 2404508(31-Mar-26), 2404509(31-Mar-26), 2405505(30-Apr-26), 2405506(30-Apr-26), 2406507(31-May-26), 2407506(30-Jun-26), 2407507(30-Jun-26), 2404506(31-Mar-26), 2406508(31-May-26), 2409501(31-Aug-26), 2409502(31-Aug-26), 2409506(31-Aug-26), 2410505(30-Sep-26), 2410506(30-Sep-26), 2411503(31-Oct-26), 2411504(31-Oct-26), 2412503(30-Nov-26), 2412504(30-Nov-26), 2501506(31-Dec-26), 2501507(31-Dec-26), 2501508(31-Dec-26), 2502501(31-Jan-27), 2501518(31-Dec-26), 2502502(31-Jan-27), 2503726(28-Feb-27), 2503727(28-Feb-27), 2504501(31-Mar-27), 2504502(31-Mar-27), 2504503(31-Mar-27). 515078/00382905150784/2402505(31-Jan-26), 2403505(28-Feb-26), 2403507(28-Feb-26), 2404501(31-Mar-26), 2404502(31-Mar-26), 2405501(30-Apr-26), 2405502(30-Apr-26), 2405503(30-Apr-26), 2405504(30-Apr-26), 2406504(31-May-26), 2406505(31-May-26), 2406506(31-May-26), 2407501(30-Jun-26), 2407502(30-Jun-26), 2407801(30-Jun-26), 2403504(28-Feb-26), 2404505(31-Mar-26), 2408501(31-Jul-26), 2409504(31-Aug-26), 2409505(31-Aug-26), 2410501(30-Sep-26), 2410502(30-Sep-26), 2410507(30-Sep-26), 2411501(31-Oct-26), 2411502(31-Oct-26), 2411508(31-Oct-26), 2412502(30-Nov-26), 2501501(31-Dec-26), 2501502(31-Dec-26), 2501503(31-Dec-26), 2502505(31-Jan-27), 2502506(31-Jan-27), 2502507(31-Jan-27), 2503728(28-Feb-27), 2504506(31-Mar-27), 2504507(31-Mar-27). 515079/00382905150791/2402601(31-Jan-26), 2403702(28-Feb-26), 2403706(28-Feb-26), 2404503(31-Mar-26), 2406501(31-May-26), 2406502(31-May-26), 2406503(31-May-26), 2408502(31-Jul-26), 2408503(31-Jul-26), 2408504(31-Jul-26), 2408505(31-Jul-26), 2410503(30-Sep-26), 2410504(30-Sep-26), 2403508(28-Feb-26), 2409503(31-Aug-26), 2411506(31-Oct-26), 2411507(31-Oct-26), 2412501(30-Nov-26), 2501504(31-Dec-26), 2501505(31-Dec-26), 2502503(31-Jan-27), 2502504(31-Jan-27), 2503504(28-Feb-27), 2503505(28-Feb-27), 2503506(28-Feb-27), 2504504(31-Mar-27), 2504505(31-Mar-27).

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from BD Switzerland Sarl

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23 Sep 2026Device	CLASS I	BD Alaris Pump Infusion Sets 10561554* recalled by BD Switzerland Sarl	BD Switzerland Sarl	Other	Nationwide
19 Aug 2026Device	CLASS II	Non-DEHP Minibore Extension Set RES ME2010 recalled	BD Switzerland Sarl	Sterility	26 states
8 Jul 2026Device	CLASS II	Medline 111 Gravity Set W/3 Needle Free Y-Sites recalled	BD Switzerland Sarl	Other	IL
24 Jun 2026Device	CLASS II	BD Connecta" BD Luer-Lok" recalled by Bd Switzerland Sarl	BD Switzerland Sarl	Foreign Material	39 states
18 Jun 2025Device	CLASS II	BD Texium recalled by Bd Switzerland Sarl	BD Switzerland Sarl	Sterility	Nationwide

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Reported	Class	Recall	Company	Reason	Where
7 Oct 2026Device	CLASS II	NOxBOXi Nitric Oxide Delivery System recalled	Noxbox	Device Malfunction	Nationwide
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7 Oct 2026Device	CLASS II	Intrapulmonary Percussive Ventilation, IPV 1, Product Number: S00065 recalled	Percussionaire	Other	Nationwide
7 Oct 2026Device	CLASS II	Positron Emission Tomography and Computed Tomography System recalled	Shanghai United Imaging Healthcare	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Intrapulmonary Percussive Ventilation, IPV-1C recalled by Percussionaire	Percussionaire	Other	Nationwide