Recall archive / FDA device enforcement

BD PhaSeal Injector Luer (N30C), REF: 515001 BD PhaSeal Injector Luer Lock (N35), REF: 515003 BD PhaSeal Injector Lue... — FDA record Z-2453-2025

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Jun 16, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: 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
Reason: 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.
Classification: Class II
Recalling firm: BD SWITZERLAND SARL
Quantity: 3,884,670
Agency-reported status: Ongoing
Source record identifier: Z-2453-2025

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	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-A...

Label field

Details supplied by the agency

Lot, code or applicability

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-A...

The agency lot list is longer than this excerpt. Read the complete list at the official source.

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

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.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date: Sep 3, 2025
Recall initiation date: Jun 16, 2025
Center classification date: Aug 27, 2025

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

What the record says

Lot and product identifiers

Distribution

Dates in the source

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