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Medium RiskFDA Device
Medical Devices/Surgical Equipment

BD PhaSeal Drug Transfer Devices Recalled for Missing Instructions

Agency Publication Date: August 27, 2025
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Summary

BD SWITZERLAND SARL has recalled approximately 3,884,670 BD PhaSeal drug transfer devices because they were shipped to the U.S. market without a U.S. version of the instructions for use. These devices, which include various injectors, protectors, connectors, and adapters, are closed systems used by healthcare professionals to safely handle and transfer hazardous drugs. While no incidents or injuries have been reported to date, the lack of proper instructions could lead to errors in how the devices are used, potentially exposing medical staff or patients to hazardous substances. Affected products were distributed nationwide across at least 38 states and the District of Columbia.

Risk

If healthcare professionals do not have access to the correct U.S. instructions, the device may be assembled or operated incorrectly. This poses a risk of exposure to hazardous drugs for the staff and potential treatment errors for patients.

What You Should Do

  1. This recall affects BD PhaSeal drug transfer systems, including Injectors, Protectors, Connectors, and adapters, sold under various model (REF) numbers including 515001, 515003, 515004, 515005, 515100, 515102, 515103, 515104, 515105, 515106, 515107, 515117, 515200, 515202, 515304, 515305, 515306, 515307, 515404, 515406, 515052, 515053, 515056, 515057, 515060, 515062, 515063, 515064, 515065, 515070, 515078, and 515079.
  2. Check your device packaging for the model (REF) number and Lot number. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled devices immediately if the instructions for use are missing or are not the U.S. version.
  4. Contact the manufacturer, BD SWITZERLAND SARL, or your medical device distributor to arrange for a return, replacement, or to obtain the correct version of the instructions for use.
  5. Call the FDA Consumer Complaint hotline at 1-888-463-6332 if you have further questions regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled devices immediately if instructions are missing. Contact the manufacturer, BD SWITZERLAND SARL, or your distributor to arrange for a return, replacement, or to obtain the correct U.S. instructions for use.

Affected Products

Product: BD PhaSeal Injector Luer (N30C)
Model / REF:
515001
UDI:
00382905150012

No lot numbers specified in recall data.

Product: BD PhaSeal Injector Luer Lock (N35)
Model / REF:
515003
Lot Numbers:
2402001 (Exp 31-Jul-26)
2403002 (Exp 31-Aug-26)
2403003 (Exp 31-Aug-26)
2404006 (Exp 30-Sep-26)
2405007 (Exp 31-Oct-26)
2405014 (Exp 31-Oct-26)
2408005 (Exp 31-Jan-27)
2408006 (Exp 31-Jan-27)
2409005 (Exp 28-Feb-27)
2403713 (Exp 31-Aug-26)
2404001 (Exp 30-Sep-26)
2404002 (Exp 30-Sep-26)
2404003 (Exp 30-Sep-26)
2404004 (Exp 30-Sep-26)
2404005 (Exp 30-Sep-26)
2410001 (Exp 31-Mar-27)
2410002 (Exp 31-Mar-27)
2411001 (Exp 30-Apr-27)
2411002 (Exp 30-Apr-27)
2411003 (Exp 30-Apr-27)
2411709 (Exp 30-Apr-27)
2412002 (Exp 31-May-27)
2501001 (Exp 30-Jun-27)
2501002 (Exp 30-Jun-27)
2501003 (Exp 30-Jun-27)
2502001 (Exp 31-Jul-27)
2502002 (Exp 31-Jul-27)
2405004 (Exp 31-Oct-26)
2405008 (Exp 31-Oct-26)
2407001 (Exp 31-Dec-26)
2412001 (Exp 31-May-27)
2503001 (Exp 31-Aug-27)
2503002 (Exp 31-Aug-27)
2503003 (Exp 31-Aug-27)
2504001 (Exp 30-Sep-27)
2504002 (Exp 30-Sep-27)
2504003 (Exp 30-Sep-27)
UDI:
00382905150036
Product: BD PhaSeal Injector Luer Lock (N35C)
Model / REF:
515004
Lot Numbers:
2405001 (Exp 31-Oct-26)
2408018 (Exp 31-Jan-27)
2411708 (Exp 30-Apr-27)
2411727 (Exp 30-Apr-27)
UDI:
00382905150043
Product: BD PhaSeal Injector Lu63er Lock (N35C Multi)
Model / REF:
515005
Lot Numbers:
2403006 (Exp 31-Aug-26)
2404008 (Exp 30-Sep-26)
2404009 (Exp 30-Sep-26)
2404010 (Exp 30-Sep-26)
2404011 (Exp 30-Sep-26)
2404012 (Exp 30-Sep-26)
2405002 (Exp 31-Oct-26)
2407010 (Exp 31-Dec-26)
2409011 (Exp 28-Feb-27)
2409012 (Exp 28-Feb-27)
2409016 (Exp 28-Feb-27)
2410007 (Exp 31-Mar-27)
2410008 (Exp 31-Mar-27)
2410010 (Exp 31-Mar-27)
2411725 (Exp 30-Apr-27)
2405003 (Exp 31-Oct-26)
2407011 (Exp 31-Dec-26)
2407012 (Exp 31-Dec-26)
2408008 (Exp 31-Jan-27)
2408009 (Exp 31-Jan-27)
2409007 (Exp 28-Feb-27)
2409008 (Exp 28-Feb-27)
2409009 (Exp 28-Feb-27)
2409010 (Exp 28-Feb-27)
2501006 (Exp 30-Jun-27)
2503738 (Exp 31-Aug-27)
2504004 (Exp 30-Sep-27)
UDI:
00382905150050
Product: BD PhaSeal Protector (P14)
Model / REF:
515100
Lot Numbers:
2504117 (Exp 31-Mar-30)
2404103 (Exp 31-Mar-29)
2404122 (Exp 31-Mar-29)
2404123 (Exp 31-Mar-29)
2406112 (Exp 31-May-29)
2406113 (Exp 31-May-29)
2404124 (Exp 31-Mar-29)
2405130 (Exp 30-Apr-29)
2407112 (Exp 30-Jun-29)
2409113 (Exp 31-Aug-29)
2410113 (Exp 30-Sep-29)
2410114 (Exp 30-Sep-29)
2411115 (Exp 31-Oct-29)
2412109 (Exp 30-Nov-29)
2502116 (Exp 31-Jan-30)
2503112 (Exp 28-Feb-30)
UDI:
00382905151002
Product: BD PhaSeal Protector (P21)
Model / REF:
515102
Lot Numbers:
2403101 (Exp 28-Feb-29)
2403102 (Exp 28-Feb-29)
2403103 (Exp 28-Feb-29)
2403104 (Exp 28-Feb-29)
2403141 (Exp 28-Feb-29)
2403707 (Exp 28-Feb-29)
2404130 (Exp 31-Mar-29)
2404131 (Exp 31-Mar-29)
2404132 (Exp 31-Mar-29)
2404141 (Exp 31-Mar-29)
2404143 (Exp 31-Mar-29)
2409601 (Exp 31-Aug-29)
2403140 (Exp 28-Feb-29)
2404125 (Exp 31-Mar-29)
2404126 (Exp 31-Mar-29)
2404127 (Exp 31-Mar-29)
2404128 (Exp 31-Mar-29)
2404129 (Exp 31-Mar-29)
2404142 (Exp 31-Mar-29)
2409108 (Exp 31-Aug-29)
2409109 (Exp 31-Aug-29)
2410701 (Exp 30-Sep-29)
2412108 (Exp 30-Nov-29)
2412114 (Exp 30-Nov-29)
2501101 (Exp 31-Dec-29)
2501102 (Exp 31-Dec-29)
2501103 (Exp 31-Dec-29)
2501104 (Exp 31-Dec-29)
2501105 (Exp 31-Dec-29)
2504108 (Exp 31-Mar-30)
2504109 (Exp 31-Mar-30)
2504119 (Exp 31-Mar-30)
UDI:
00382905151026
Product: BD PhaSeal Protector (P21 Multi)
Model / REF:
515103
Lot Numbers:
2404133 (Exp 31-Mar-29)
2404134 (Exp 31-Mar-29)
2404140 (Exp 31-Mar-29)
2410101 (Exp 30-Sep-29)
2410102 (Exp 30-Sep-29)
2410103 (Exp 30-Sep-29)
2410104 (Exp 30-Sep-29)
2504111 (Exp 31-Mar-30)
UDI:
00382905151033
Product: BD PhaSeal Protector (P28)
Model / REF:
515104
Lot Numbers:
2410119 (Exp 30-Sep-29)
2410107 (Exp 30-Sep-29)
UDI:
00382905151040
Product: BD PhaSeal Protector (P50)
Model / REF:
515105
Lot Numbers (73):
2402112 (Exp 31-Jan-29)
2403122 (Exp 28-Feb-29)
2403123 (Exp 28-Feb-29)
2403124 (Exp 28-Feb-29)
2403125 (Exp 28-Feb-29)
2403127 (Exp 28-Feb-29)
2404113 (Exp 31-Mar-29)
2404115 (Exp 31-Mar-29)
2404117 (Exp 31-Mar-29)
2405101 (Exp 30-Apr-29)
2405102 (Exp 30-Apr-29)
2405106 (Exp 30-Apr-29)
2405107 (Exp 30-Apr-29)
2405108 (Exp 30-Apr-29)
2405152 (Exp 30-Apr-29)
2406104 (Exp 31-May-29)
2406105 (Exp 31-May-29)
2406106 (Exp 31-May-29)
2406107 (Exp 31-May-29)
2406109 (Exp 31-May-29)
2407103 (Exp 30-Jun-29)
2407104 (Exp 30-Jun-29)
2407106 (Exp 30-Jun-29)
2407107 (Exp 30-Jun-29)
2407108 (Exp 30-Jun-29)
2407109 (Exp 30-Jun-29)
2409103 (Exp 31-Aug-29)
2409602 (Exp 31-Aug-29)
2411123 (Exp 31-Oct-29)
2411125 (Exp 31-Oct-29)
2411126 (Exp 31-Oct-29)
2411707 (Exp 31-Oct-29)
2412105 (Exp 30-Nov-29)
2403126 (Exp 28-Feb-29)
2404102 (Exp 31-Mar-29)
2404110 (Exp 31-Mar-29)
2404111 (Exp 31-Mar-29)
2404112 (Exp 31-Mar-29)
2404114 (Exp 31-Mar-29)
2404116 (Exp 31-Mar-29)
2404118 (Exp 31-Mar-29)
2404119 (Exp 31-Mar-29)
2405103 (Exp 30-Apr-29)
2405104 (Exp 30-Apr-29)
2405105 (Exp 30-Apr-29)
2407102 (Exp 30-Jun-29)
2407105 (Exp 30-Jun-29)
2409104 (Exp 31-Aug-29)
2409105 (Exp 31-Aug-29)
2411113 (Exp 31-Oct-29)
UDI:
00382905151057
Product: BD PhaSeal Protector (P50 Multi)
Model / REF:
515106
Lot Numbers (54):
2403109 (Exp 28-Feb-29)
2403110 (Exp 28-Feb-29)
2403111 (Exp 28-Feb-29)
2403112 (Exp 28-Feb-29)
2403113 (Exp 28-Feb-29)
2403114 (Exp 28-Feb-29)
2403115 (Exp 28-Feb-29)
2403116 (Exp 28-Feb-29)
2403117 (Exp 28-Feb-29)
2403118 (Exp 28-Feb-29)
2403119 (Exp 28-Feb-29)
2403120 (Exp 28-Feb-29)
2403121 (Exp 28-Feb-29)
2404101 (Exp 31-Mar-29)
2404104 (Exp 31-Mar-29)
2404105 (Exp 31-Mar-29)
2404106 (Exp 31-Mar-29)
2404107 (Exp 31-Mar-29)
2404108 (Exp 31-Mar-29)
2405119 (Exp 30-Apr-29)
2405120 (Exp 30-Apr-29)
2405121 (Exp 30-Apr-29)
2405122 (Exp 30-Apr-29)
2405123 (Exp 30-Apr-29)
2405124 (Exp 30-Apr-29)
2405125 (Exp 30-Apr-29)
2405126 (Exp 30-Apr-29)
2405127 (Exp 30-Apr-29)
2405128 (Exp 30-Apr-29)
2405129 (Exp 30-Apr-29)
2406101 (Exp 31-May-29)
2406102 (Exp 31-May-29)
2406103 (Exp 31-May-29)
2407101 (Exp 30-Jun-29)
2408101 (Exp 31-Jul-29)
2409102 (Exp 31-Aug-29)
2410110 (Exp 30-Sep-29)
2409101 (Exp 31-Aug-29)
2410108 (Exp 30-Sep-29)
2410109 (Exp 30-Sep-29)
2411101 (Exp 31-Oct-29)
2411102 (Exp 31-Oct-29)
2411103 (Exp 31-Oct-29)
2411104 (Exp 31-Oct-29)
2412106 (Exp 30-Nov-29)
2412107 (Exp 30-Nov-29)
2501110 (Exp 31-Dec-29)
2502102 (Exp 31-Jan-30)
2502103 (Exp 31-Jan-30)
2503107 (Exp 28-Feb-30)
UDI:
00382905151064
Product: BD PhaSeal Protector (P53)
Model / REF:
515107
Lot Numbers:
2407115 (Exp 30-Jun-29)
UDI:
00382905151071
Product: BD PhaSeal Protector (P55)
Model / REF:
515117
Lot Numbers:
2405131 (Exp 30-Apr-29)
2405132 (Exp 30-Apr-29)
2405133 (Exp 30-Apr-29)
2405134 (Exp 30-Apr-29)
2407113 (Exp 30-Jun-29)
2407114 (Exp 30-Jun-29)
2409115 (Exp 31-Aug-29)
2409120 (Exp 31-Aug-29)
2409121 (Exp 31-Aug-29)
2409122 (Exp 31-Aug-29)
2411117 (Exp 31-Oct-29)
2503111 (Exp 28-Feb-30)
2504115 (Exp 31-Mar-30)
2504116 (Exp 31-Mar-30)
UDI:
00382905151170
Product: BD PhaSeal Connector Luer Lock (C35)
Model / REF:
515200
Lot Numbers:
2403715 (Exp 29-Feb-28)
2404208 (Exp 31-Mar-28)
2405203 (Exp 30-Apr-28)
2407204 (Exp 30-Jun-28)
2409202 (Exp 31-Aug-28)
2411202 (Exp 31-Oct-28)
2501201 (Exp 31-Dec-28)
2405204 (Exp 30-Apr-28)
2407203 (Exp 30-Jun-28)
2409201 (Exp 31-Aug-28)
2410201 (Exp 30-Sep-28)
2410202 (Exp 30-Sep-28)
2411201 (Exp 31-Oct-28)
2411203 (Exp 31-Oct-28)
2501202 (Exp 31-Dec-28)
2502201 (Exp 31-Jan-29)
2503201 (Exp 28-Feb-29)
2503202 (Exp 28-Feb-29)
2504201 (Exp 31-Mar-29)
2504202 (Exp 31-Mar-29)
UDI:
00382905152009
Product: BD PhaSeal Connector Luer Lock (C45)
Model / REF:
515202
Lot Numbers:
2404207 (Exp 31-Mar-28)
2404202 (Exp 31-Mar-28)
2407201 (Exp 30-Jun-28)
2412202 (Exp 30-Nov-28)
2501222 (Exp 31-Dec-28)
2503206 (Exp 28-Feb-29)
2504203 (Exp 31-Mar-29)
UDI:
00382905152023
Product: BD PhaSeal Y-site Connector (C80)
Model / REF:
515304
Lot Numbers:
2406206 (Exp 30-Sep-26)
2412212 (Exp 31-Jan-27)
2503802 (Exp 30-Apr-27)
UDI:
00382905153044
Product: BD PhaSeal L Connector (C90)
Model / REF:
515305
Lot Numbers:
2403220 (Exp 29-Feb-28)
2405221 (Exp 30-Apr-28)
2405222 (Exp 30-Apr-28)
2409218 (Exp 31-Aug-28)
2404201 (Exp 31-Mar-28)
2404206 (Exp 31-Mar-28)
2502215 (Exp 31-Jan-29)
UDI:
00382905153051
Product: BD PhaSeal Infusion Adapter (C100)
Model / REF:
515306
Lot Numbers:
2402228 (Exp 31-Jan-29)
2404210 (Exp 31-Mar-28)
2404211 (Exp 31-Mar-28)
2404212 (Exp 31-Mar-28)
2404213 (Exp 31-Mar-28)
2404214 (Exp 31-Mar-28)
2404215 (Exp 31-Mar-28)
2404216 (Exp 31-Mar-28)
2406204 (Exp 31-May-28)
2410212 (Exp 30-Sep-28)
2410213 (Exp 30-Sep-28)
2412216 (Exp 30-Nov-28)
2404209 (Exp 31-Mar-28)
2405224 (Exp 30-Apr-28)
2502213 (Exp 31-Jan-29)
2502214 (Exp 31-Jan-29)
2406202 (Exp 31-May-28)
2406203 (Exp 31-May-28)
2410217 (Exp 30-Sep-28)
2411206 (Exp 31-Oct-28)
2411207 (Exp 31-Oct-28)
2411721 (Exp 31-Oct-28)
2411722 (Exp 31-Oct-28)
2411723 (Exp 31-Oct-28)
2412205 (Exp 30-Nov-28)
2412206 (Exp 30-Nov-28)
2412217 (Exp 30-Nov-28)
2501213 (Exp 31-Dec-28)
2501214 (Exp 31-Dec-28)
2503207 (Exp 28-Feb-29)
2503208 (Exp 28-Feb-29)
2503209 (Exp 28-Feb-29)
2504204 (Exp 31-Mar-29)
2504205 (Exp 31-Mar-29)
2504206 (Exp 31-Mar-29)
UDI:
00382905153068
Product: BD PhaSeal Infusion Adapter (C100 Multi)
Model / REF:
515307
Lot Numbers:
2403714 (Exp 29-Feb-28)
2502212 (Exp 31-Jan-29)
2403601 (Exp 28-Feb-26)
2405225 (Exp 30-Apr-28)
2410216 (Exp 30-Sep-28)
UDI:
00382905153075
Product: BD PhaSeal Cap for Injector (M50)
Model / REF:
515404
Lot Numbers:
2404203 (Exp 31-Mar-29)
2409220 (Exp 31-Aug-29)
2405201 (Exp 30-Apr-29)
2405202 (Exp 30-Apr-29)
2406205 (Exp 31-May-29)
UDI:
00382905154041
Product: BD PhaSeal Connector Cap (M70)
Model / REF:
515406
Lot Numbers:
2404217 (Exp 31-Mar-29)
UDI:
00382905154065
Product: BD PhaSeal Optima Injector (N35-O)
Model / REF:
515052
Lot Numbers:
2403303 (Exp 31-Aug-26)
2403304 (Exp 31-Aug-26)
2403306 (Exp 31-Aug-26)
2403307 (Exp 31-Aug-26)
2404301 (Exp 30-Sep-26)
2406303 (Exp 30-Nov-26)
2406702 (Exp 30-Nov-26)
2406801 (Exp 30-Nov-26)
2408305 (Exp 31-Jan-27)
2409302 (Exp 28-Feb-27)
2410304 (Exp 31-Mar-27)
2410306 (Exp 31-Mar-27)
2411301 (Exp 30-Apr-27)
2411302 (Exp 30-Apr-27)
2412305 (Exp 31-May-27)
2501303 (Exp 30-Jun-27)
2501304 (Exp 30-Jun-27)
2501305 (Exp 30-Jun-27)
2502303 (Exp 31-Jul-27)
2502304 (Exp 31-Jul-27)
2502305 (Exp 31-Jul-27)
2503301 (Exp 31-Aug-27)
2405301 (Exp 31-Oct-26)
2405302 (Exp 31-Oct-26)
2405303 (Exp 31-Oct-26)
2406302 (Exp 30-Nov-26)
2406310 (Exp 30-Nov-26)
2406803 (Exp 30-Nov-26)
2407301 (Exp 31-Dec-26)
2407302 (Exp 31-Dec-26)
2407303 (Exp 31-Dec-26)
2408304 (Exp 31-Jan-27)
2408306 (Exp 31-Jan-27)
2408307 (Exp 31-Jan-27)
2408308 (Exp 31-Jan-27)
2409301 (Exp 28-Feb-27)
2409303 (Exp 28-Feb-27)
2409304 (Exp 28-Feb-27)
2410305 (Exp 31-Mar-27)
2410307 (Exp 31-Mar-27)
2503716 (Exp 31-Aug-27)
2503717 (Exp 31-Aug-27)
2503721 (Exp 31-Aug-27)
2503722 (Exp 31-Aug-27)
2504303 (Exp 30-Sep-27)
2504304 (Exp 30-Sep-27)
2504305 (Exp 30-Sep-27)
2504306 (Exp 30-Sep-27)
2504307 (Exp 30-Sep-27)
UDI:
00382905150524
Product: BD PhaSeal Optima Injector (N35-O Multi)
Model / REF:
515053
Lot Numbers:
2404302 (Exp 30-Sep-26)
2404303 (Exp 30-Sep-26)
2404304 (Exp 30-Sep-26)
2409305 (Exp 28-Feb-27)
2409306 (Exp 28-Feb-27)
2409307 (Exp 28-Feb-27)
2405304 (Exp 31-Oct-26)
2405305 (Exp 31-Oct-26)
2410308 (Exp 31-Mar-27)
2412303 (Exp 31-May-27)
2412304 (Exp 31-May-27)
2501301 (Exp 30-Jun-27)
2501302 (Exp 30-Jun-27)
2406701 (Exp 30-Nov-26)
2406703 (Exp 30-Nov-26)
2407304 (Exp 31-Dec-26)
2407305 (Exp 31-Dec-26)
2407306 (Exp 31-Dec-26)
2407307 (Exp 31-Dec-26)
2407308 (Exp 31-Dec-26)
2407802 (Exp 31-Dec-26)
2408309 (Exp 31-Jan-27)
2408310 (Exp 31-Jan-27)
2411303 (Exp 30-Apr-27)
2501601 (Exp 30-Jun-27)
2502701 (Exp 31-Jul-27)
2502702 (Exp 31-Jul-27)
2502703 (Exp 31-Jul-27)
2502704 (Exp 31-Jul-27)
2503723 (Exp 31-Aug-27)
2503724 (Exp 31-Aug-27)
2503725 (Exp 31-Aug-27)
2504308 (Exp 30-Sep-27)
UDI:
00382905150531
Product: BD PhaSeal Injector Locking (N40-O)
Model / REF:
515056
Lot Numbers:
2405306 (Exp 31-Oct-26)
2405307 (Exp 31-Oct-26)
2405308 (Exp 31-Oct-26)
2405312 (Exp 31-Oct-26)
2408301 (Exp 31-Jan-27)
2406301 (Exp 30-Nov-26)
2409310 (Exp 28-Feb-27)
2410301 (Exp 31-Mar-27)
2410303 (Exp 31-Mar-27)
2411304 (Exp 30-Apr-27)
2411305 (Exp 30-Apr-27)
2412301 (Exp 31-May-27)
2501306 (Exp 30-Jun-27)
2501307 (Exp 30-Jun-27)
2501308 (Exp 30-Jun-27)
2502301 (Exp 31-Jul-27)
2502302 (Exp 31-Jul-27)
2407309 (Exp 31-Dec-26)
2407310 (Exp 31-Dec-26)
2408302 (Exp 31-Jan-27)
2409309 (Exp 28-Feb-27)
2410302 (Exp 31-Mar-27)
2410309 (Exp 31-Mar-27)
2411306 (Exp 30-Apr-27)
2503736 (Exp 31-Aug-27)
2503737 (Exp 31-Aug-27)
2504301 (Exp 30-Sep-27)
2504801 (Exp 30-Sep-27)
UDI:
00382905150562
Product: BD PhaSeal Injector Locking (N40-O Multi)
Model / REF:
515057
Lot Numbers:
2405311 (Exp 31-Oct-26)
2409308 (Exp 28-Feb-27)
2411308 (Exp 30-Apr-27)
2412302 (Exp 31-May-27)
2501309 (Exp 30-Jun-27)
2501310 (Exp 30-Jun-27)
2408303 (Exp 31-Jan-27)
2411307 (Exp 30-Apr-27)
2504302 (Exp 30-Sep-27)
UDI:
00382905150579
Product: BD PhaSeal Optima Protector (P13-O)
Model / REF:
515060
Lot Numbers:
2403413 (Exp 28-Feb-26)
2403415 (Exp 28-Feb-26)
2404408 (Exp 31-Mar-26)
2404409 (Exp 31-Mar-26)
2405409 (Exp 30-Apr-26)
2405410 (Exp 30-Apr-26)
2405412 (Exp 30-Apr-26)
2405413 (Exp 30-Apr-26)
2405414 (Exp 30-Apr-26)
2405415 (Exp 30-Apr-26)
2406407 (Exp 31-May-26)
2407805 (Exp 30-Jun-26)
2407806 (Exp 30-Jun-26)
2407807 (Exp 30-Jun-26)
2403414 (Exp 28-Feb-26)
2404407 (Exp 31-Mar-26)
2404410 (Exp 31-Mar-26)
2405411 (Exp 30-Apr-26)
2407803 (Exp 30-Jun-26)
2407804 (Exp 30-Jun-26)
2408406 (Exp 31-Jul-26)
2408407 (Exp 31-Jul-26)
2408408 (Exp 31-Jul-26)
2409411 (Exp 31-Aug-26)
2409413 (Exp 31-Aug-26)
2410402 (Exp 30-Sep-26)
2410408 (Exp 30-Sep-26)
2410409 (Exp 30-Sep-26)
2410410 (Exp 30-Sep-26)
2410416 (Exp 30-Sep-26)
2410417 (Exp 30-Sep-26)
2410602 (Exp 30-Sep-26)
2411413 (Exp 31-Oct-26)
2411414 (Exp 31-Oct-26)
2412407 (Exp 30-Nov-26)
2412408 (Exp 30-Nov-26)
2412409 (Exp 30-Nov-26)
2412410 (Exp 30-Nov-26)
2412411 (Exp 30-Nov-26)
2412701 (Exp 30-Nov-26)
2501406 (Exp 31-Dec-26)
2409412 (Exp 31-Aug-26)
2409414 (Exp 31-Aug-26)
2409415 (Exp 31-Aug-26)
2409416 (Exp 31-Aug-26)
2412412 (Exp 30-Nov-26)
2412414 (Exp 30-Nov-26)
2501407 (Exp 31-Dec-26)
2501408 (Exp 31-Dec-26)
2504409 (Exp 31-Mar-27)
UDI:
00382905150609
Product: BD PhaSeal Optima Protector (P13-O Multi)
Model / REF:
515062
UDI:
00382905150623

No lot numbers specified in recall data.

Product: BD PhaSeal Optima Protector (P28-O)
Model / REF:
515063
Lot Numbers:
2502706 (Exp 31-Mar-27)
2502705 (Exp 31-Mar-27)
UDI:
00382905150630
Product: BD PhaSeal Optima Protector (P20-O)
Model / REF:
515064
Lot Numbers (84):
2402405 (Exp 31-Jan-26)
2403401 (Exp 28-Feb-26)
2403404 (Exp 28-Feb-26)
2403405 (Exp 28-Feb-26)
2403408 (Exp 28-Feb-26)
2403409 (Exp 28-Feb-26)
2403410 (Exp 28-Feb-26)
2403411 (Exp 28-Feb-26)
2403412 (Exp 28-Feb-26)
2403703 (Exp 28-Feb-26)
2403704 (Exp 28-Feb-26)
2404403 (Exp 31-Mar-26)
2404404 (Exp 31-Mar-26)
2404405 (Exp 31-Mar-26)
2404411 (Exp 31-Mar-26)
2404412 (Exp 31-Mar-26)
2404416 (Exp 31-Mar-26)
2405401 (Exp 30-Apr-26)
2405403 (Exp 30-Apr-26)
2405407 (Exp 30-Apr-26)
2405408 (Exp 30-Apr-26)
2405417 (Exp 30-Apr-26)
2406402 (Exp 31-May-26)
2406403 (Exp 31-May-26)
2406404 (Exp 31-May-26)
2406411 (Exp 31-May-26)
2406412 (Exp 31-May-26)
2406413 (Exp 31-May-26)
2406414 (Exp 31-May-26)
2406415 (Exp 31-May-26)
2406416 (Exp 31-May-26)
2407402 (Exp 30-Jun-26)
2407403 (Exp 30-Jun-26)
2407404 (Exp 30-Jun-26)
2408410 (Exp 31-Jul-26)
2408413 (Exp 31-Jul-26)
2408414 (Exp 31-Jul-26)
2405402 (Exp 30-Apr-26)
2407415 (Exp 30-Jun-26)
2408403 (Exp 31-Jul-26)
2408404 (Exp 31-Jul-26)
2408411 (Exp 31-Jul-26)
2408412 (Exp 31-Jul-26)
2409401 (Exp 31-Aug-26)
2409402 (Exp 31-Aug-26)
2409403 (Exp 31-Aug-26)
2409405 (Exp 31-Aug-26)
2411403 (Exp 31-Oct-26)
2411404 (Exp 31-Oct-26)
2411411 (Exp 31-Oct-26)
UDI:
00382905150647
Product: BD PhaSeal Optima Protector (P20-O Multi)
Model / REF:
515065
Lot Numbers (79):
2402404 (Exp 31-Jan-26)
2402411 (Exp 31-Jan-26)
2402412 (Exp 31-Jan-26)
2403403 (Exp 28-Feb-26)
2403406 (Exp 28-Feb-26)
2403416 (Exp 28-Feb-26)
2403417 (Exp 28-Feb-26)
2404401 (Exp 31-Mar-26)
2404402 (Exp 31-Mar-26)
2404406 (Exp 31-Mar-26)
2405404 (Exp 30-Apr-26)
2405405 (Exp 30-Apr-26)
2405406 (Exp 30-Apr-26)
2406401 (Exp 31-May-26)
2406405 (Exp 31-May-26)
2406406 (Exp 31-May-26)
2406408 (Exp 31-May-26)
2406409 (Exp 31-May-26)
2406410 (Exp 31-May-26)
2407401 (Exp 30-Jun-26)
2407405 (Exp 30-Jun-26)
2407406 (Exp 30-Jun-26)
2407407 (Exp 30-Jun-26)
2407408 (Exp 30-Jun-26)
2407409 (Exp 30-Jun-26)
2407416 (Exp 30-Jun-26)
2407417 (Exp 30-Jun-26)
2408401 (Exp 31-Jul-26)
2408405 (Exp 31-Jul-26)
2408417 (Exp 31-Jul-26)
2409404 (Exp 31-Aug-26)
2409407 (Exp 31-Aug-26)
2409408 (Exp 31-Aug-26)
2404417 (Exp 31-Mar-26)
2408402 (Exp 31-Jul-26)
2409406 (Exp 31-Aug-26)
2410406 (Exp 30-Sep-26)
2411401 (Exp 31-Oct-26)
2411402 (Exp 31-Oct-26)
2411418 (Exp 31-Oct-26)
2412404 (Exp 30-Nov-26)
2501401 (Exp 31-Dec-26)
2501413 (Exp 31-Dec-26)
2501418 (Exp 31-Dec-26)
2410401 (Exp 30-Sep-26)
2502405 (Exp 31-Jan-27)
2410404 (Exp 30-Sep-26)
2410405 (Exp 30-Sep-26)
2502409 (Exp 31-Jan-27)
2502415 (Exp 31-Jan-27)
UDI:
00382905150654
Product: BD PhaSeal Optima Connector (C35-O)
Model / REF:
515070
Lot Numbers:
2403701 (Exp 28-Feb-26)
2403705 (Exp 28-Feb-26)
2404507 (Exp 31-Mar-26)
2404508 (Exp 31-Mar-26)
2404509 (Exp 31-Mar-26)
2405505 (Exp 30-Apr-26)
2405506 (Exp 30-Apr-26)
2406507 (Exp 31-May-26)
2407506 (Exp 30-Jun-26)
2407507 (Exp 30-Jun-26)
2404506 (Exp 31-Mar-26)
2406508 (Exp 31-May-26)
2409501 (Exp 31-Aug-26)
2409502 (Exp 31-Aug-26)
2409506 (Exp 31-Aug-26)
2410505 (Exp 30-Sep-26)
2410506 (Exp 30-Sep-26)
2411503 (Exp 31-Oct-26)
2411504 (Exp 31-Oct-26)
2412503 (Exp 30-Nov-26)
2412504 (Exp 30-Nov-26)
2501506 (Exp 31-Dec-26)
2501507 (Exp 31-Dec-26)
2501508 (Exp 31-Dec-26)
2502501 (Exp 31-Jan-27)
2501518 (Exp 31-Dec-26)
2502502 (Exp 31-Jan-27)
2503726 (Exp 28-Feb-27)
2503727 (Exp 28-Feb-27)
2504501 (Exp 31-Mar-27)
2504502 (Exp 31-Mar-27)
2504503 (Exp 31-Mar-27)
UDI:
00382905150708
Product: BD PhaSeal Optima Infusion Adapter (C100-O)
Model / REF:
515078
Lot Numbers:
2402505 (Exp 31-Jan-26)
2403505 (Exp 28-Feb-26)
2403507 (Exp 28-Feb-26)
2404501 (Exp 31-Mar-26)
2404502 (Exp 31-Mar-26)
2405501 (Exp 30-Apr-26)
2405502 (Exp 30-Apr-26)
2405503 (Exp 30-Apr-26)
2405504 (Exp 30-Apr-26)
2406504 (Exp 31-May-26)
2406505 (Exp 31-May-26)
2406506 (Exp 31-May-26)
2407501 (Exp 30-Jun-26)
2407502 (Exp 30-Jun-26)
2407801 (Exp 30-Jun-26)
2403504 (Exp 28-Feb-26)
2404505 (Exp 31-Mar-26)
2408501 (Exp 31-Jul-26)
2409504 (Exp 31-Aug-26)
2409505 (Exp 31-Aug-26)
2410501 (Exp 30-Sep-26)
2410502 (Exp 30-Sep-26)
2410507 (Exp 30-Sep-26)
2411501 (Exp 31-Oct-26)
2411502 (Exp 31-Oct-26)
2411508 (Exp 31-Oct-26)
2412502 (Exp 30-Nov-26)
2501501 (Exp 31-Dec-26)
2501502 (Exp 31-Dec-26)
2501503 (Exp 31-Dec-26)
2502505 (Exp 31-Jan-27)
2502506 (Exp 31-Jan-27)
2502507 (Exp 31-Jan-27)
2503728 (Exp 28-Feb-27)
2504506 (Exp 31-Mar-27)
2504507 (Exp 31-Mar-27)
UDI:
00382905150784
Product: BD PhaSeal Optima Infusion Adapter (C100-O Multi)
Model / REF:
515079
Lot Numbers:
2402601 (Exp 31-Jan-26)
2403702 (Exp 28-Feb-26)
2403706 (Exp 28-Feb-26)
2404503 (Exp 31-Mar-26)
2406501 (Exp 31-May-26)
2406502 (Exp 31-May-26)
2406503 (Exp 31-May-26)
2408502 (Exp 31-Jul-26)
2408503 (Exp 31-Jul-26)
2408504 (Exp 31-Jul-26)
2408505 (Exp 31-Jul-26)
2410503 (Exp 30-Sep-26)
2410504 (Exp 30-Sep-26)
2403508 (Exp 28-Feb-26)
2409503 (Exp 31-Aug-26)
2411506 (Exp 31-Oct-26)
2411507 (Exp 31-Oct-26)
2412501 (Exp 30-Nov-26)
2501504 (Exp 31-Dec-26)
2501505 (Exp 31-Dec-26)
2502503 (Exp 31-Jan-27)
2502504 (Exp 31-Jan-27)
2503504 (Exp 28-Feb-27)
2503505 (Exp 28-Feb-27)
2503506 (Exp 28-Feb-27)
2504504 (Exp 31-Mar-27)
2504505 (Exp 31-Mar-27)
UDI:
00382905150791

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97070
Status: Active
Manufacturer: BD SWITZERLAND SARL
Sold By: Authorized Medical Distributors; Healthcare Facilities
Manufactured In: Switzerland
Units Affected: 3,884,670
Distributed To: California, Washington, Alabama, Ohio, North Carolina, Georgia, Massachusetts, Illinois, Missouri, Arizona, Pennsylvania, Mississippi, Minnesota, Michigan, Texas, Virginia, Indiana, Nevada, Colorado, Florida, West Virginia, Wisconsin, New York, New Jersey, Utah, Maryland, Montana, New Mexico, Tennessee, Hawaii, Oklahoma, Oregon, Alaska, District of Columbia, Iowa, Louisiana, Maine, South Carolina

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.