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U.S. Department of Health and Human Services

Class 2 Device Recall MEDLINE CONVENIENCE KITS

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 Class 2 Device Recall MEDLINE CONVENIENCE KITSsee related information
Date Initiated by FirmFebruary 27, 2026
Date PostedApril 17, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1877-2026
Recall Event ID 98601
Product Classification Cardiac catheterization kit - Product Code OES
ProductMedline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ADULT CATH PACK-LF DYNJ38395G ANGIO DRAPE PACK (ADLUG)642-LF DYNJ47665F DYNJ47665G ANGIO KIT PACK DYNJ83746 DYNJ83746A ANGIO PACK DYNJ30565G DYNJ51239C DYNJ66631A DYNJ69200A DYNJ88276 ANGIO PHC DYNJ37485D ANGIO TRAY 116118 DYNJ37724K ANGIO TRAY NO LIDO DYNJ85557 DYNJ85557B ANGIOGRAM-30852 DYNJVB91148A ANGIOGRAPHY DRAPE PACK-LF DYNJ0373221P ANGIOGRAPHY PACK DYNJ17218R DYNJ44293F DYNJ44293G DYNJ44293J DYNJ83516 ANGIOGRAPHY PACK-LF DYNJ0854485X ARTERIOGRAM DYNJ28082I BASIC HEART CATH PACK DYNJVB1075B CARDIAC CATH DYNJ910293 CARDIAC CATH PACK DYNJ68653B DYNJ68653C CARDIAC CATH PACK-LF DYNJ85258 CATH LAB (EP) PACK DYNJ65162B CATH LAB ANGIO PACK-LF DYNJ0545064AA CATH LAB ANGIO TRAY DYNJ83506A CATH LAB PACK DYNJ66366D DYNJ66366F DYNJT2202U CATH LAB PROCEDURE PK DYNJ57723C CATH LAB TRAY DYNJ37389P DYNJ37389Q CATH PACK DYNJ62595C DYNJ62595D DYNJ69997A HEART CATH PACK DYNJ85783 HEART CATH-SFMC DYNJ82434 INTERVENTIONAL PACK DYNJ56666D INTERVENTIONAL PACK-LF DYNJ37211J INTERVENTIONAL RADIOLOGY PK-LF DYNJ0516014AI IR PACK DYNJ36752B JUDKINS PACK DYNJ51126C M&E ANGIOGRAPHY PK DYNJ83812 NEURO ANGIO PACK DYNJ51697C NEUROLOGICAL CATH PACK DYNJ63434D OR HYBRID-MRMC DYNJ907758C PTCA PACK DYNJ55359C DYNJ55359D RADIOLOGY ANGIO MAJOR PACK DYNJ62858C SURGERY ANGIO PACK-LF PHS677784013B ANGIO ARTERIOGRAM PACK-LF DYNJ0774026J ANGIO IR PACK DYNJ31196G ANGIO PACK DYNJ30565F, DYNJ69200 ANGIOGRAM PACK-LF DYNJ21574K, DYNJ21574L ANGIOGRAPHY PACK DYNJ26855G, DYNJ26855I BGMC CARDIAC CATH PACK-LF DYNJ0664960D CARDIAC CATH DYNJ59898B CARDIAC CATH PACK DYNJ68653A, DYNJ69150A CATH LAB ANGIO PACK-LF DYNJ0545064Y CATH LAB PACK DYNJ28428F, DYNJ80457 CATH LAB-LF DYNJ51423F CATH PACK DYNJ62595B, DYNJ62983A CATH PROCEDURAL TRAY DYNJ43580D GENERAL ANGIO PACK DYNJ57760C HEART CATH PACK DYNJ69318 HEART CATH TRAY DYNJ53251J, DYNJ81557 IR PACK DYNJ65312 MAIN OR CATH LAB DYNJ61373A M CARDIAC CATH DYNJ58339A N CATH PACK NG140A OR RADIOLOGY PACK DYNJ62747 RADIOLOGY PACK DYNJ42633C R ANGIO PACK DYNJ36338C SPECIAL TRAY DYNJ65756A TAVR PACK DYNJ69246
Code Information DYNJ0373221P UDI-DI 10195327506575 (EA) 40195327506576 (CS) LOTS 24ABR861 DYNJ0516014AI UDI-DI 10198459246234 (EA) 40198459246235 (CS) LOTS 25BME135 25EMI244 DYNJ0545064AA UDI-DI 10195327327385 (EA) 40195327327386 (CS) LOTS 23CMD735 24BMA467 24CME416 24DMG231 24EMI752 24FMD170 24HMD253 24JMC552 24LMA043 25AMJ675 25CMB252 25EMD050 25EMF726 DYNJ0854485X UDI-DI 10195327450366 (EA) 40195327450367 (CS) LOTS 23GMA609 23HMF271 23IMH767 23JMI189 23LMH350 24DMC322 24FMB078 24HMA888 24HMJ182 24LMB120 DYNJ17218R UDI-DI 10195327459642 (EA) 40195327459643 (CS) LOTS 23GDA609 23HDB136 23IDB699 23KDA473 DYNJ28082I UDI-DI 10195327429713 (EA) 40195327429714 (CS) LOTS 23HBC876 23KBE157 24BBC678 24DBN465 24FBQ528 24GBO066 24HBF409 24KBG843 DYNJ30565G UDI-DI 10195327140687 (EA) 40195327140688 (CS) LOTS 22DDB753 22FDB429 22HDB442 22KDA279 22LDB909 23BDB812 23EDA339 23GDA440 23IDA647 23IDB341 23KDB268 24BDA252 24CDB812 24EDC035 24HDC110 24IMA915 24JMI363 24KMG704 24LMF893 DYNJ36752B UDI-DI 10195327226022 (EA) 40195327226023 (CS) LOT 23IMD713 DYNJ37211J UDI-DI 10195327363673 (EA) 40195327363674 (CS) LOTS 24ABL975 24BBM554 24DBA215 24EBF356 24FBR841 24HBF463 24IBV426 24KBC581 24LBM346 DYNJ37389P UDI-DI 10195327201418 (EA) 40195327201419 (CS) LOTS 23DBO927 23FBC559 23GBF169 23GBJ160 23IBM982 DYNJ37389Q UDI-DI 10195327531270 (EA) 40195327531271 (CS) LOTS 23KBL184 23LMC983 23LMG114 24AME115 24BMJ169 24CMB351 24CMI800 24FMH298 24GMH700 24HMH956 24IMI993 24KMF785 24LMF430 DYNJ37485D UDI-DI 10195327397333 (EA) 40195327397334 (CS) LOTS 23DBP804 23FBH420 23GBF219 23HBJ487 23IBO358 23KBA337 23LBC194 24ABI270 24CMD265 24CMG190 24EMJ851 24GMK004 24HMF977 24JMC975 24KMH243 24LMG715 DYNJ37724K UDI-DI 10195327531256 (EA) 40195327531257 (CS) LOTS 23JBS842 23LMF451 24BMH462 24EMI397 24EMJ503 24GMK100 24HMH553 24JMA589 24KMJ234 DYNJ38395G UDI-DI 10195327286767 (EA) 40195327286768 (CS) LOTS 22LMF926 23BMA411 23DMD076 23DMG120 DYNJ44293F UDI-DI 10195327265182 (EA) 40195327265183 (CS) LOTS 23CBH106 DYNJ44293G UDI-DI 10195327427276 (EA) 40195327427277 (CS) LOTS 23HBI186 23HBX788 23IBP108 23JBQ388 23JBT471 23KBX452 23LBU382 24ABH531 24ABU590 24CBQ251 24FBS495 24HBB684 DYNJ44293J UDI-DI 10198459252471 (EA) 40198459252472 (CS) LOTS 25ABS436 25CBC411 25DBS739 25EBN111 25GBK945 DYNJ47665F UDI-DI 10195327355210 (EA) 40195327355211 (CS) LOTS 23GMI750 23IMG679 DYNJ47665G UDI-DI 10195327535810 (EA) 40195327535811 (CS) LOTS 23KMC220 23LMD957 24AMH318 24CMC513 24CMF048 24EMF765 24FMB398 24GMD088 24HMG619 24KMC285 DYNJ51126C UDI-DI 10195327299996 (EA) 40195327299997 (CS) LOTS 24EBL991 24GBL127 24HBB815 24IBI837 24KBT622 DYNJ51239C UDI-DI 10195327663728 (EA) 40195327663729 (CS) LOTS 24FBM878 DYNJ51697C UDI-DI 10195327517267 (EA) 40195327517268 (CS) LOTS 24HBJ453 24JBQ619 24KBL433 DYNJ55359C UDI-DI 10198459167447 (EA) 40198459167448 (CS) LOTS 24JBW626 24LBJ492 25ABM557 DYNJ55359D UDI-DI 10198459253584 (EA) 40198459253585 (CS) LOTS 25CBJ836 25EBB180 25FBC620 DYNJ56666D UDI-DI 10195327366780 (EA) 40195327366781 (CS) LOTS 23FMB079 23HMC084 23JMH176 DYNJ57723C UDI-DI 10195327533007 (EA) 40195327533008 (CS) LOT 24GMA688 DYNJ62595C UDI-DI 10195327386511 (EA) 40195327386512 (CS) LOTS 23FBD527 23FBK131 DYNJ62595D UDI-DI 10195327482626 (EA) 40195327482627 (CS) LOTS 23IBD384 23JBT585 23KBV027 23LBS746 24ABX161 24BBA663 24DBO214 24EBN761 24GBJ844 24IBT077 24JBX775 24KBR861 DYNJ62858C UDI-DI 10195327265212 (EA) 40195327265213 (CS) LOTS 23GMB070 24BMD149 24HMA369 24HMJ618 24JME908 DYNJ63434D UDI-DI 10195327611200 (EA) 40195327611201 (CS) LOTS 24BBU728 24CBK568 24FBE982 24GBP703 24HBS440 24JBD723 24JBN341 24LBQ810 DYNJ65162B UDI-DI 10195327443948 (EA) 40195327443949 (CS) LOTS 23KBA866 23LBL832 DYNJ66366D UDI-DI 10195327493387 (EA) 40195327493388 (CS) LOTS 23LMC414 24BMD428 24EMG916 24EMJ523 24GMC227 24GMG298 24GMI398 DYNJ66366F UDI-DI 10198459033117 (EA) 40198459033118 (CS) LOTS 24HMI310 24IMB847 24IMD381 DYNJ66631A UDI-DI 10195327225193 (EA) 40195327225194 (CS) LOTS 23ABB849 23ABP692 23BBP518 23HBN017 23IBO135 24BBU796 24EBA783 24GBD375 24HBG027 24IBG782 24JBU401 24KBH848 24LBE218 DYNJ68653B UDI-DI 10195327475970 (EA) 40195327475971 (CS) LOTS 23IBO333 23JBE362 23KBS420 DYNJ68653C UDI-DI 10195327626570 (EA) 40195327626571 (CS) LOTS 24BBU897 24EBB962 24EBJ449 24FBR693 24HBB850 DYNJ69200A UDI-DI 10195327489410 (EA) 40195327489411 (CS) LOTS 23IMC515 24AMD850 24DMH188 24FMF806 24JMF887 24JMJ455 DYNJ69997A UDI-DI 10195327260385 (EA) 40195327260386 (CS) LOTS 23KBU803 23LBM407 24ABP852 24BBV440 24DBE698 24EBF945 24FBD806 24FBO409 24HBD424 24IBA964 24JBH315 24KBF590 DYNJ82434 UDI-DI 10195327195991 (EA) 40195327195992 (CS) LOTS 23EBW505 23HBD267 23KBT910 DYNJ83506A UDI-DI 10195327366186 (EA) 40195327366187 (CS) LOTS 23FBD320 23GBC962 23HBI399 23JBR658 23LBG496 24ABV721 24CBC537 24CBU407 24EBC887 24FBC272 24GBS961 24HBQ313 24JBA160 24JBW202 DYNJ83516 UDI-DI 10195327277017 (EA) 40195327277018 (CS) LOTS 23FBR130 24EBL005 24FBG676 24GBO653 DYNJ83746 UDI-DI 10195327300692 (EA) 40195327300693 (CS) LOTS 23FBJ158 DYNJ83746A UDI-DI 10195327450199 (EA) 40195327450190 (CS) LOTS 23LBO128 24DBN523 24EBC851 24FBC179 DYNJ83812 UDI-DI 10195327310097 (EA) 40195327310098 (CS) LOTS 23GBU635 23HBC113 23JBX909 DYNJ85258 UDI-DI 10195327485696 (EA) 40195327485697 (CS) LOT 24CBQ941 DYNJ85557 UDI-DI 10195327516802 (EA) 40195327516803 (CS) LOT 23LBV118 DYNJ85557B UDI-DI 10198459140099 (EA) 40198459140090 (CS) LOT 24LBL658 DYNJ85783 UDI-DI 10195327548858 (EA) 40195327548859 (CS) LOT 24BBB824 DYNJ88276 UDI-DI 10198459139963 (EA) 40198459139964 (CS) LOT 24JBP183 DYNJ907758C UDI-DI 10195327193836 (EA) 40195327193837 (CS) LOT 23CBJ259 DYNJ910293 UDI-DI 10195327618711 (EA) 40195327618712 (CS) LOT 24CBB990 24DBP431 24GBO286 24GBP221 24HBL812 24KBG045 24KBN510 24LBR413 25CBJ733 25DBD091 25DBM647 DYNJT2202U UDI-DI 10195327263010 (EA) 40195327263011 (CS) LOTS 23HME786 DYNJVB1075B UDI-DI 10195327254735 (EA) 40195327254736 (CS) LOTS 23JLA749 DYNJVB91148A UDI-DI 10198459182372 (EA) 40198459182373 (CS) LOTS 25DLA750 25ELB006 25GLA721 PHS677784013B UDI-DI 10195327498887 (EA) 40195327498888 (CS) LOTS 24HMG073 24IMA820 24IME550 24KMB118 DYNJ0774026J UDI-DI 10193489271645 (EA) 40193489271646 (CS) LOTS 23BME179 23CMH777 23EMG669 23FMD595 23HMB354 23IMH606 23JMA027 24ABV703 DYNJ31196G UDI-DI 10198459095610 (EA) 40198459095611 (CS) LOTS 24HBW974 24JBJ110 DYNJ30565F UDI-DI 10195327031961 (EA) 40195327031962 (CS) LOTS 21JDC595 21LDA804 22CDA234 DYNJ69200 UDI-DI 10193489906813 (EA) 40193489906814 (CS) LOTS 23DMF486 23EMF929 23FMF496 23GMB826 23GMI809 DYNJ21574K UDI-DI 10195327008970 (EA) 40195327008971 (CS) LOTS 23FLA441 23GLB169 23ILA271 23JLA395 23JLA665 23KLB042 23LLA789 24BLA140 24BLB079 24DLA079 24FLA280 DYNJ21574L UDI-DI 10198459094385 (EA) 40198459094386 (CS) LOTS 24HLA450 24HLA848 24ILA065 24JLA291 24KLA039 24KLA924 24LLA313 DYNJ26855G UDI-DI 10195327008956 (EA) 40195327008957 (CS) LOTS 22ABE569 22ABZ784 22BBD499 22EBM551 22FBP986 22JBT802 22OBH709 23BBT658 23EBR341 23KBC736 23LBP243 24BBH599 24BBU885 24DBH273 24EBA834 24FBD738 24GBF739 24GBW918 DYNJ26855I UDI-DI 10198459094392 (EA) 40198459094393 (CS) LOTS 24IBR372 24JBS600 24KBO719 DYNJ0664960D UDI-DI 10193489397031 (EA) 40193489397032 (CS) LOTS 24GBE748 24GBV256 24IBO585 24JBC423 24JBG501 24KBK205 DYNJ59898B UDI-DI 10195327037130 (EA) 40195327037131 (CS) LOT 23JBN221 DYNJ68653A UDI-DI 10195327095703 (EA) 40195327095704 (CS) LOTS 23BBS119 23EBK331 23FBG953 23GBQ487 DYNJ69150A UDI-DI 10195327046330 (EA) 40195327046331 (CS) LOT 24BBB818 DYNJ0545064Y UDI-DI 10193489469042 (EA) 40193489469043 (CS) LOTS 21CBO976 21DBA926 21FBO930 21HBC707 21HBQ780 21KBG377 21LBB707 21LBM663 22BBT446 22CBE190 22DMH122 22EMF009 22FMH972 22GMB541 22IME216 22KMD333 22LMG693 DYNJ28428F UDI-DI 10889942218448 (EA) 40889942218449 (CS) LOTS 23EBV379 23GBM428 23HBG542 23JBH720 23JBR648 24BBI852 24CBC564 24CBK578 24DBS782 24GBJ992 24HBR901 24JBO787 DYNJ80457 UDI-DI 10195327039417 (EA) 40195327039418 (CS) LOT 24ABT460 DYNJ51423F UDI-DI 10193489456813 (EA) 40193489456814 (CS) LOTS 23ELA935 23FLB069 23GLA872 23GLA983 23HLB130 23JLA430 23JLA961 23LLA538 DYNJ62595B UDI-DI 10193489930443 (EA) 40193489930444 (CS) LOT 23CBK312 DYNJ62983A UDI-DI 10193489324792 (EA) 40193489324793 (CS) LOTS 23CMD917 23IME947 DYNJ43580D UDI-DI 10193489922622 (EA) 40193489922623 (CS) LOTS 23EDB907 23FDB773 23IDB785 23JDA831 23LDA819 24ADB496 24CDA214 24EDB119 24FDB521 24GDB467 24IDA596 24JDA196 24JDB828 24JDC323 DYNJ57760C UDI-DI 10195327079390 (EA) 40195327079391 (CS) LOTS 23FMI541 23GMC743 23IMC143 23IMD071 23JMG748 24BMD271 24CMF285 24FMD857 24HMG516 24IMB711 24JMH057 DYNJ69318 UDI-DI 10193489930344 (EA) 40193489930345 (CS) LOT 23BME178 DYNJ53251J UDI-DI 10193489965469 (EA) 40193489965460 (CS) LOTS 23BBB184 23BBJ802 23CBF225 23KBH360 24ABB431 24BBQ972 24CBN146 24DBR758 24GBP113 24HBS157 24IBG551 24IBH388 24KBM359 DYNJ81557 UDI-DI 10195327122621 (EA) 40195327122622 (CS) LOT 24DBN954 DYNJ65312 UDI-DI 10193489266405 (EA) 40193489266406 (CS) LOT 24ABP045 DYNJ61373A UDI-DI 10195327014698 (EA) 40195327014699 (CS) LOTS 23GBF047 23KBD741 23KBL501 23LBL092 DYNJ58339A UDI-DI 10193489483147 (EA) 40193489483148 (CS) LOT 24DBG343 NG140A UDI-DI 10889942945474 (EA) 40889942945475 (CS) LOT 23IBK929 DYNJ62747 UDI-DI 10193489687149 (EA) 40193489687140 (CS) LOT 23JBI082 DYNJ42633C UDI-DI 10193489810493 (EA) 40193489810494 (CS) LOTS 23FMG920 23FMH918 DYNJ36338C UDI-DI 10193489915532 (EA) 40193489915533 (CS) LOTS 23DMH629 23FME052 23IME630 23JMI386 23KMB592 23LMI240 24AMI028 DYNJ65756A UDI-DI 10193489423273 (EA) 40193489423274 (CS) LOTS 23EBR170 23FBJ964 DYNJ69246 UDI-DI 10193489917970 (EA) 40193489917971 (CS) LOTS 23BBM275 24CBQ263 24DBM916 24DBR138 24EBJ938 24IBH260 24JBF386 24JBT909 ***Updated 5/20/26 - The following lots were included in the customer notification but were erroneously omitted from FDA submission.*** DYNJ0664960D Lots 22BMH371 22CMC415 22EMC395 22HMA045 22IMA207 22IMH395 22KMA148 22KME310 23AMF897 23BMA101 23CMC444 23DMI595 23FBT283 23FMB607 23HBG453 23IBJ858 23KBR740 24BBE411 25BBE129 25CBK692 25CBL405; DYNJ0774026J Lots 21AMC513 21JMF113 21JMG031 21KMH257 22BMG580 22CME054 22CMH215 22HMD856 22JMI033 23AMA912 23AMA913 23BMA919 23EMC120 23GMB529; DYNJ21574K Lots 21JLA945 21KLA853 22ALA604 22BLA248 22CLB146 22ELB114 22GLA930 22HLA111 22HLA273 22ILA326 22JLA709 22KLA738 23ALA838 23BLA577 23CLA743 23DLA672 23DLA862 23ELA433; DYNJ21574L Lots 25ABP571 25ALA224 25CBL413; DYNJ26855G Lots 22KBH184 22KBH187 22KBW271 23CBU979 23DBJ420 23FBV657 23HBV978; DYNJ26855I Lots 25ABS101 25CBP637; DYNJ28428F Lots 21ABE606 21ABX433 21DBY170 21FBJ513 21HBL286 21KBL869 21LBW789 22BBZ883 22EBL952 22FBL846 22HBD442 22IBK193 22KBA938 22OBH723 23ABO267 23BBO094 23DBR441; DYNJ30565F Lots 22ADB192; DYNJ36338C Lots 21FMA808 21HMA558 21JMB764 21KMB724 21KMG896 21LME033 22AMA454 22AMC503 22AMD333 22AMD669 22CME152 22DMA962 22FMF229 22GME871 22HMF490 22HMF491 22LMD108 22LMD109 23AMD169 23CMC655 23EMG065 23GMG999; DYNJ43580D Lots 21HDB002 21IDA328 22ADA853 22ADB914 22BDA682 22DDA018 22GDA604 22JDB108 22KDA603 22LDA587 23CDB423 23DDA524 23EDA193 23HDA952 25ADA786 25CDA860 25DDB647; DYNJ51423F Lots 21BMA533 21BMC382 21DMD570 21EME514 21FMF497 21HMF227 21IMG702 21JMF701 22AMB754 22CME045 22CMI781 22DME838 22ELA971 22EMD527 22HLA188 22HLB263 22ILA267 22JLA278 22KLA321 22LLA091 23BLA350 23BLA675 23BLA970 23DLA222; DYNJ53251J Lots 22ELA480 22FLA093 22FLA778 22HLB264 22ILA736 22KBM371 22LBG230 23DBA349 23EBF780 23FBO855 23IBF068; DYNJ57760C Lots 22AMB380 22AMF802 22AMG614 22CMI270 22EMF515 22IMC996 22IMD003 23AMB106 23DMB626 23EMI855 25BMA402 25BMF957 25DMB075 25EMF632; DYNJ59898B Lots 22GBM877; DYNJ61373A Lots 21JMC103 21KMF078 21LMG304 22FMA200 22HMF897 22LMI439 23AMC909 23BMA352 23DMI379; DYNJ62595B Lots 21GBI606 21IBQ183 21KBH759 21KBH852 22ABC865 22BBG092 22EBF374 22EBM342 22GBL120 22HBU026 22JBD037 22KBO462 23ABH032 23BBG807 23DBB324; DYNJ62983A Lots 21FME305 21GMA862 22CMB536 23CMF038; DYNJ68653A Lots 22BBY312 22DBQ489 22EBL391 22GBZ211 22HBD649 22IBL267 22JBU310 22LBS024 23BBI165; DYNJ69200 Lots 21FME681 21HMB876 21IMC917 21JMD933 21JMI310 21KME674 22AME702 22FMA061 22FME489 22HMC803 22IMF050 22KMD085; DYNJ69246 Lots 21GBF658 21IBF761 22BBR453 22DBG565 22DBL761 22DBQ762 22FBN799 22GBV212 22GBV631 22IBA366 22IBL998 22LBH201 23BBS113 23DBP363 23EBU262 23FBQ188 23FBU876 23HBC446 23IBR816 23JBM664 23JBY394 23LBD914 24ABW660; DYNJ69318 Lots 21HMA008 21JMF648 21KMB459 22AMB554 22DMG103 22GMF851 22HMF642 22LMI947; DYNJ0545064AA Lots 23DMD621 23EME923 23FMD499 23HMA183 23IMC062 23KMA689; DYNJ28082I Lots 23GBC376; DYNJ30565G Lots 25BMF623; DYNJ37211J Lots 23CBU820 23DBS754 23FBU325 23HBT944 23JBA287 23LBH723 25ABW234 25CBI624; DYNJ37389P Lots 22IBD442 22JBI417 22KBJ960 22LBM305 23ABG699 23BBO067 23CBW125 23HBP088 23HBX781; DYNJ37389Q Lots 25BMB454 25CMD795 25EMD467; DYNJ37485D Lots 25AMJ305 25CMA151; DYNJ44293F Lots 22KBD454 23ABF404 23BBA548 23BBK630 23EBI351; DYNJ44293G Lots 24FBI497; DYNJ47665F Lots 23DMB165; DYNJ51126C Lots 23ABM214 23BBP534 23EBS133 23HBE509 23HBJ990 23IBJ494 23JBW154 23KBL881 24ABQ378 24CBH872 25ABD115 25BBP620 25CBF365; DYNJ51697C Lots 23JBJ820 23JBV985 23KBK659 24ABY364 24ABY589 24CBI875 24DBS165; DYNJ56666D Lots 23CMG612; DYNJ62595C Lots 23GBR603; DYNJ62595D Lots 24ABW004 25ABM934; DYNJ62858C Lots 25DMH376; DYNJ63434D Lots 24ABQ391 25EBQ015; DYNJ66366D Lots 23IMF996 23IMH874; DYNJ66366F Lots 25AMI656 25BMG505 25DMH492; DYNJ66631A Lots 22JBI275 22KBD175 25ABG940 25BBC391 25CBL495 25EBL467; DYNJ69200A Lots 25CMC399; DYNJ69997A Lots 22JBJ752 22LBE072 23ABO318 23DBF723 23EBS260 23FBR213 23HBJ664 23HBR069 23IBU588 25ABC945 25ABM804; DYNJ82434 Lots 22GBI888 22JBH646 22KBS435 23ABP641 23BBU305 23DBN593; DYNJ83506A Lots 23DBB771 23IBW275 25ABQ327 25BBS217 25EBC671; DYNJ83516 Lots 23ABB567 25BBC442; DYNJ83746 Lots 23BBJ812 23DBO406; DYNJ83746A Lots 23HBP852 23IBQ994; DYNJ83812 Lots 23BBQ875 23IBQ978; DYNJ85557B Lots 25ABD786 25ABU479 25BBT267 25CBH200 25EBI339; DYNJ88276 Lots 25CBS899 25EBF002; DYNJ907758C Lots 22LBH052 23ABL480 23BBK917; DYNJT2202U Lots 23AMD707; PHS677784013B Lots 25BMA486 25BMI667 25CMG487 25EMJ834
FEI Number 1417592
Recalling Firm/
Manufacturer		 Medline Industries, LP
3 Lakes Dr
Northfield IL 60093-2753
For Additional Information ContactHaley Barclay
800-633-5463
Manufacturer Reason
for Recall		Unapproved design changes to the products outside of the 510(k) clearance.
FDA Determined
Cause 2		Component change control
ActionOn February 27, 2026, the firm began notifying customers via email and first-class mail. Customers were instructed to request over-labels to place on affected kits containing recalled syringes instructing them to remove the recalled component and replace with product from their supply.
Quantity in Commerce270,311 total
DistributionWorldwide distribution - US Nationwide and the countries of Canada, Panama, Barbados.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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