Class II FDA device recall · Z-2453-2025

Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.

This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.

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

Why it was 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.

Is your unit affected?

The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.

A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.

Show the FDA's listed lot / code information

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), 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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), 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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).

Recall status

Ongoing — the recall is still being carried out.

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.

Recall record

Recalling firm: BD SWITZERLAND SARL
Product type: Devices
Recall number: Z-2453-2025
Voluntary / mandated: Voluntary: Firm initiated
Initial notification: Letter
Origin: Eysins
Recall initiated: 2025-06-16

What to do

Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.

Also available: structured data (JSON-LD) · recall record (JSON)

What this is — and is not

A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.

To report a problem you experienced, use FDA MedWatch. Verify this record at FDA recalls · Recall Z-2453-2025 · Source: openFDA enforcement.