BD PhaSeal Injector Luer (N30C), REF: 515001 recallZ-2453-2025 · Bd Switzerland Sarl · initiated Jun 16, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Bd Switzerland Sarl or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Error in labeling
What the company is doing
On 6/16/2025, Medical Device Product Advisory notices were mailed and emailed to customers who were asked to do the following: 1) The US IFU to be attached to your product can be accessed and downloaded from the following link by searching under the applicable product code: The US IFU to be attached to your product can be accessed and downloaded from the following link by searching under the applicable product code: eIFU.bd.com 2) Circulate this notice to all those who need to be aware within your organization or to any organization where the potentially affected products have been transferred. 3) Complete the attached Customer Response Form and return via email to [email protected] Distributors were asked to do the following: Identify all customers within your distribution network that purchased any affected product as defined in this notification. Provide a copy of the attached customer letter to all customers to advise them of this product advisory on recalling firm's behalf. Report any complaints experienced with the use of this product to firm via the North American Regional Complaint Center: Phone: 1-844-823-5433 Say "Product Complaints" when prompted Mon-Fri 8:00am to 5:00pm CT, Email: [email protected]
Recall details
- Recall number
- Z-2453-2025
- Status
- Open, Classified
- Initiated by the company
- Jun 16, 2025
- Posted by the FDA
- Aug 27, 2025
- Recalling firm
- Bd Switzerland Sarl
- Quantity
- 3,884,670
- Product code
- ONB
- FDA submissions
- K123213, K130197, K140591, K181221, K201099
- 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.
Product description
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
Code information (models, lots, serial numbers)
Show the full code information (16k characters)
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).
Devices named in this recall
32 devices in the FDA device registry whose identifier appears in the recall's code information.
- BD PhaSeal 515003BD Switzerland Sàrl · Closed antineoplastic and hazardous drug reconstitution and transfer system1 recall183 reports
- BD PhaSeal 515056BD Switzerland Sàrl · Closed antineoplastic and hazardous drug reconstitution and transfer system1 recall159 reports
- BD PhaSeal Optima 515070BD Switzerland Sàrl · Closed antineoplastic and hazardous drug reconstitution and transfer system1 recall154 reports
- BD PhaSeal 515005BD Switzerland Sàrl · Closed antineoplastic and hazardous drug reconstitution and transfer system1 recall128 reports
- BD PhaSeal Optima 515052BD Switzerland Sàrl · Closed antineoplastic and hazardous drug reconstitution and transfer system1 recall114 reports
- BD PhaSeal Optima 515064BD Switzerland Sàrl · Closed antineoplastic and hazardous drug reconstitution and transfer system1 recall73 reports
- BD PhaSeal 515105BD Switzerland Sàrl · Closed antineoplastic and hazardous drug reconstitution and transfer system1 recall71 reports
- BD PhaSeal 515117BD Switzerland Sàrl · Closed antineoplastic and hazardous drug reconstitution and transfer system1 recall71 reports
- BD PhaSeal 515304BD Switzerland Sàrl · Closed antineoplastic and hazardous drug reconstitution and transfer system2 recalls16 reports
- BD PhaSeal 515106BD Switzerland Sàrl · Closed antineoplastic and hazardous drug reconstitution and transfer system1 recall64 reports
- BD PhaSeal 515306BD Switzerland Sàrl · Closed antineoplastic and hazardous drug reconstitution and transfer system1 recall54 reports
- BD PhaSeal Optima 515078BD Switzerland Sàrl · Closed antineoplastic and hazardous drug reconstitution and transfer system1 recall41 reports
- BD PhaSeal 515200BD Switzerland Sàrl · Closed antineoplastic and hazardous drug reconstitution and transfer system1 recall37 reports
- BD PhaSeal 515102BD Switzerland Sàrl · Closed antineoplastic and hazardous drug reconstitution and transfer system1 recall35 reports
- BD PhaSeal 515004BD Switzerland Sàrl · Closed antineoplastic and hazardous drug reconstitution and transfer system1 recall34 reports
- BD PhaSeal 515107BD Switzerland Sàrl · Closed antineoplastic and hazardous drug reconstitution and transfer system1 recall33 reports
- BD PhaSeal 515100BD Switzerland Sàrl · Closed antineoplastic and hazardous drug reconstitution and transfer system1 recall25 reports
- BD PhaSeal Optima 515060BD Switzerland Sàrl · Closed antineoplastic and hazardous drug reconstitution and transfer system1 recall24 reports
- BD PhaSeal™ Optima 515057BD Switzerland Sàrl · Closed antineoplastic and hazardous drug reconstitution and transfer system1 recall21 reports
- BD PhaSeal 515202BD Switzerland Sàrl · Closed antineoplastic and hazardous drug reconstitution and transfer system1 recall20 reports
- BD PhaSeal Optima 515053BD Switzerland Sàrl · Closed antineoplastic and hazardous drug reconstitution and transfer system1 recall15 reports
- BD PhaSeal 515065BD Switzerland Sàrl · Closed antineoplastic and hazardous drug reconstitution and transfer system1 recall12 reports
- BD PhaSeal Optima 515079BD Switzerland Sàrl · Closed antineoplastic and hazardous drug reconstitution and transfer system1 recall6 reports
- BD PhaSeal 515104BD Switzerland Sàrl · Closed antineoplastic and hazardous drug reconstitution and transfer system1 recall4 reports
- BD PhaSeal 515001BD Switzerland Sàrl · Closed antineoplastic and hazardous drug reconstitution and transfer system1 recall2 reports
- BD PhaSeal 515305BD Switzerland Sàrl · Closed antineoplastic and hazardous drug reconstitution and transfer system1 recall2 reports
- PhaSeal Optima 515063Becton Dickinson Pen Limited · Closed antineoplastic and hazardous drug reconstitution and transfer system1 recall1 report
- BD PhaSeal 515103BD Switzerland Sàrl · Closed antineoplastic and hazardous drug reconstitution and transfer system1 recall1 report
- BD PhaSeal 515307BD Switzerland Sàrl · Closed antineoplastic and hazardous drug reconstitution and transfer system1 recall1 report
- BD PhaSeal 515404BD Switzerland Sàrl · Closed antineoplastic and hazardous drug reconstitution and transfer system1 recall1 report
- BD PhaSeal Optima 515062BD Switzerland Sàrl · Closed antineoplastic and hazardous drug reconstitution and transfer system1 recall0 reports
- BD PhaSeal 515406BD Switzerland Sàrl · Closed antineoplastic and hazardous drug reconstitution and transfer system1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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