Limited official informationFDA Medical Device Enforcement ReportsRecall date: Jul 1, 2026

Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. CATARACT FULL BODY DYNJ85743 MAJOR VASCULAR PACK DYNJ8161...

Full official product description

Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. CATARACT FULL BODY DYNJ85743 MAJOR VASCULAR PACK DYNJ81610C MINIMALLY INVASIVE PACK-LF DYNJ0843063L PEDIATRIC CATH ANGIO PACK DYNJ54755J PERIPHERAL ARTERIOGRAM RAD DYNJ61383C POSTERIOR SPINE PACK-LF DYNJ0843339O UPPER EXTREMITY DYNJ61907A VISCERAL ANGIOGRAM PACK-LF DYNJ0429121L | Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ANGIO PACK DYNJ30565C DYNJ32555B ANGIO PACK-LF DYNJ0774765U ANGIO TRAY DYNJ46153A ANGIOGRAM TRAY DYNJ33638K ANGIOGRAPHY DRAPE PK QVH-LF DYNJ35110D ANGIOGRAPHY PACK DYNJ44293D ANGIOGRAPHY PACK-LF DYNJ0854485T DYNJ35916J GENERAL ANGIO PACK DYNJ57760B GENERAL ENDO PACK-LF DYNJ0842873J JUDKINS PACK DYNJ51126A RADIOLOGY ANGIO MAJOR PACK DYNJ62858B TAVR JUDKINS PACK DYNJ51127B | Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. CRANIOTOMY PACK-LF DYNJ0101292F DYNJ0101292G HYBRID PACK DYNJ65925A LAMINECTOMY DYNJ905156L DYNJ905156M DYNJ905156N DYNJ905156O DYNJ905156P MAJOR EXTREMITY DYNJ905159F DYNJ905159I DYNJ905159J DYNJ905159K NEURO CERVICAL PACK DYNJ0101287J DYNJ0101287K NEURO SPINE PACK DYNJ81612C POSTERIOR SPINE PACK-LF DYNJ0843339L DYNJ0843339M DYNJ0843339N SPINE PACK DYNJ30150F | Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ANGIO CATH COMBINED PACK DYNJ43609S ANGIO PACK DYNJ67987D DYNJ80317A ANGIO SPECIAL PROCEDURE-LF DYNJ38412C ANGIOGRAM SET UP PACK DYNJ66260A ANGIOGRAPHY PACK DYNJ44293I ANGIOGRAPHY PACK-LF DYNJ0854485W CARDIAC CATH PACK DYNJ82709 CARDIAC CATH PACK-LF DYNJ0261554AL DYNJ31103F CATH LAB ANGIO TRAY DYNJ83506 CATH LAB PACK DYNJ66366C MSC-GREEN BAY ST VINCENT SAMPC0686 NEUROLOGICAL CATH PACK DYNJ63434B OR HYBRID-MRMC DYNJ907758B STEWARD OR ANGIO PACK GSS DYNJ80925B | Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ANGIO DRAPE PACK (ADLUG)642-LF DYNJ47665D ANGIO PACK DYNJ30565D ANGIOGRAPHY PACK-LF DYNJ0854485V ARTERIOGRAM DYNJ28082D DYNJ28082F CARDIAC CATH DYNJ67349 CARDIAC CATH PACK DYNJ57874C CATH I PLUS-LF DYNJSCL100 CATH III PLUS-LF DYNJSCL300 CATH LAB ANGIOGRAPHY PACK DYNJ50779F CATH LAB PACK DYNJ41088B DYNJ48085 CATH LAB TRAY DYNJ37389N DYNJ37389O CATH PACK DYNJ62595A DYNJ69997 EP DRAPE PACK-LF DYNJ47645B HOSPITAL REGIONAL DE CONCEPCIO DYNJ67918A INTERVENTIONAL PACK DYNJ56666C INTERVENTIONAL RAD PACK DYNJ44100L INTERVENTIONAL RADIOLOGY PACK DYNJ43664 INTERVENTIONAL RADIOLOGY PK-LF DYNJ0516014AF OR HYBRID-MRMC DYNJ907758A VMA TRAY DYNJ62376A | Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. AAA DYNJ905651B ARTERIOGRAM TRAY 00-402001S AV SHUNT PACK-LF DYNJ0842516F BASIC IR PACK-LF PHS463660F CATH PROCEDURAL TRAY DYNJ43580C CONGENITAL ADD-ON KIT DYNDA2213A CUSTOM PROCEDURE KIT DYNJ65277A DEEP BRAIN STIMULATION PACK DYNJ0842793F HOSPITAL REGIONAL DE CONCEPCIO DYNJ67918 INTERVENTIONAL PACK DYNJ56666B INVASIVE LINE INSERTION DYNJ44123A JUDKINS PACK DYNJ51126B LARKIN CUSTOM NEURO TRAY PAIN1454 MAJOR PLUS PACK DYNJ905160I MINIMALLY INVASIVE PACK-LF DYNJ0843063J NEURO ANGIO PACK SJF-LF DYNJ37304F NON-VASCULAR PACK DYNJ56386B OR HYBRID-MRMC DYNJ907758 PACER PACK DYNJ40952 PAIN PACK DYNJ60715 PICC PHC DYNJ37484B ROBOTIC PACK DYNJ908706A THORACOTOMY PACK-LF DYNJ0101339J DYNJ69090 VENOUS PACK DYNJ56260B | Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ANGIOGRAM PACK-LF DYNJ21574J JUDKINS PACK DYNJ51126 | Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. CENTRAL LINE TRAY DYNJ41089 FISTULAGRAM PACK DYNJ62827A FISTULOGRAM PACK DYNJ47899A INVASIVE LINE INSERTION DYNJ44123B NON VASCULAR PACK DYNJ68037A VASCULAR ACCESS PACK-LF DYNJ0101291F | Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. MAJOR BASIN SET DYNJ85723 | Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. PICC LINEPACK (PCLUI)642-LF DYNJ47717A

Verification delayed

The last verified facts remain visible. Last successful verification: Aug 5, 2026, 7:44 AM UTC. A temporary source failure does not mean the recall changed.

Official information is incomplete

Missing: action, consumer scope. The page is public for lookup but excluded from search indexing and advertising.

1Is my item affected?

Compare the complete identifiers. Name similarity alone is not a confirmed match.

Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. CATARACT FULL BODY DYNJ85743 MAJOR VASCULAR PACK DYNJ81610C MINIMALLY INVASIVE PACK-LF DYNJ0843063L PEDIATRIC CATH ANGIO PACK DYNJ54755J PERIPHERAL ARTERIOGRAM RAD DYNJ61383C POSTERIOR SPINE PACK-LF DYNJ0843339O UPPER EXTREMITY DYNJ61907A VISCERAL ANGIOGRAM PACK-LF DYNJ0429121L; Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ANGIO PACK DYNJ30565C DYNJ32555B ANGIO PACK-LF DYNJ0774765U ANGIO TRAY DYNJ46153A ANGIOGRAM TRAY DYNJ33638K ANGIOGRAPHY DRAPE PK QVH-LF DYNJ35110D ANGIOGRAPHY PACK DYNJ44293D ANGIOGRAPHY PACK-LF DYNJ0854485T DYNJ35916J GENERAL ANGIO PACK DYNJ57760B GENERAL ENDO PACK-LF DYNJ0842873J JUDKINS PACK DYNJ51126A RADIOLOGY ANGIO MAJOR PACK DYNJ62858B TAVR JUDKINS PACK DYNJ51127B; plus 8 additional official variants listed below.

Identifiers to compare

  • UDI 10195327542337
  • UDI 10195327556938
  • UDI 10195327567071
  • UDI 10195327549909
  • UDI 10195327593346
  • UDI 10195327567057
  • UDI 10195327542450
  • UDI 10195327587697
  • UDI 10889942165704
  • UDI 10884389648216
  • UDI 10193489634594
  • UDI 10889942185863
  • UDI 10193489343281
  • UDI 10193489329940
  • UDI 10193489833416
  • UDI 10193489864199
  • UDI 10193489838404
  • UDI 10193489342581
  • UDI 10193489448917
  • UDI 10193489854886
  • UDI 10193489891263
  • UDI 10193489854893
  • UDI 10193489434040
  • UDI 10195327286255
  • UDI 10193489427264
  • UDI 10193489397369
  • UDI 10193489908961
  • UDI 10193489996371
  • UDI 10195327219949
  • UDI 10195327405847
  • UDI 10193489397475
  • UDI 10195327219987
  • UDI 10195327406028
  • UDI 10195327556884
  • UDI 10195327286484
  • UDI 10195327500177
  • UDI 10195327536145
  • UDI 10193489345544
  • UDI 10193489964615
  • UDI 10195327286552
  • UDI 10889942186679
  • UDI 10195327322984
  • UDI 10195327265496
  • UDI 10195327410780
  • UDI 10195327291792
  • UDI 10195327185749
  • UDI 10198459152108
  • UDI 10195327403430
  • UDI 10195327202590
  • UDI 10195327467760
  • UDI 10195327461317
  • UDI 10195327272890
  • UDI 10195327232887
  • UDI 10195327195489
  • UDI 10195327335502
  • UDI 10195327181000
  • UDI 10195327624903
  • UDI 10193489952827
  • UDI 10193489905205
  • UDI 10195327096885
  • UDI 10193489268676
  • UDI 10193489949452
  • UDI 10193489895728
  • UDI 10193489976618
  • UDI 10884389625583
  • UDI 10884389625606
  • UDI 10193489436068
  • UDI 10889942632794
  • UDI 10888277546035
  • UDI 10193489306019
  • UDI 10193489925302
  • UDI 10193489364262
  • UDI 10195327004743
  • UDI 10193489952834
  • UDI 10195327042776
  • UDI 10193489876079
  • UDI 10193489808810
  • UDI 10888277065475
  • UDI 10193489346978
  • UDI 10193489978384
  • UDI 10193489933598
  • UDI 10193489925067
  • UDI 10889942893645
  • UDI 10193489352375
  • UDI 10195327096991
  • UDI 10889942249398
  • UDI 10889942925421
  • UDI 10193489409536
  • UDI 10193489345230
  • UDI 10193489459081
  • UDI 10888277740273
  • UDI 10889942952977
  • UDI 10195327044138
  • UDI 10193489688863
  • UDI 10193489397482
  • UDI 10193489345377
  • UDI 10889942727919
  • UDI 10888277762886
  • UDI 10193489872002
  • UDI 10884389898826
  • UDI 10193489520279
  • UDI 10889942777792
  • UDI 10195327406042
  • UDI 10193489472516
  • UDI 10193489883596
  • UDI 10193489569827
  • UDI 10889942153497
  • UDI 10889942122820
  • UDI 10884389891360
  • UDI 10193489306606
  • UDI 10889942574681
  • UDI 10195327381653
  • UDI 10195327003630
  • UDI 10195327286644
  • UDI 10195327538491
  • UDI 10193489454529
  • Lot 24ABP082
  • Lot 24BBB405
  • Lot 23LDB992
  • Lot 24ABJ741
  • Lot 24CLA801
  • Lot 24CDB480
  • Lot 24ABP069
  • Lot 24BMH315
  • Lot 21CDA555
  • Lot 21AMA053
  • Lot 21FLA468
  • Lot 20XBH471
  • Lot 21HLA726
  • Lot 21IMC537
  • Lot 21CBE250
  • Lot 21FBC416
  • Lot 21CBF463
  • Lot 21CME104
  • Lot 21ADA204
  • Lot 21DDA694
  • Lot 21FMF601
  • Lot 22FBV791
  • Lot 21CDC411
  • Lot 22KDB031
  • Lot 21BLA577
  • Lot 21EBI411
  • Lot 21HBC497
  • Lot 21LBQ932
  • Lot 22HBR341
  • Lot 23GBH099
  • Lot 21CBF265
  • Lot 22JMF458
  • Lot 23FMC192
  • Lot 23LMF481
  • Lot 23ADA628
  • Lot 23JDC525
  • Lot 24BBB406
  • Lot 21EDC223
  • Lot 21HDB435
  • Lot 23ADA251
  • Lot 24BBE416
  • Lot 23BMG740
  • Lot 22LMI014
  • Lot 23JLA076
  • Lot 24CME277
  • Lot 22GMH445
  • Lot 24JBX196
  • Lot 23EMI244
  • Lot 22KBG072
  • Lot 23IMA846
  • Lot 23ILA143
  • Lot 22LBM317
  • Lot 22HME111
  • Lot 22HDA577
  • Lot 23CBG406
  • Lot 22GBD778
  • Lot 24CBG978
  • Lot 21HBJ571
  • Lot 21FDB653
  • Lot 22CMB440
  • Lot 21ABN806
  • Lot 21HBM290
  • Lot 23JMA721
  • Lot 24ABM611
  • Lot 24ABM801
  • Lot 24ABM802
  • Lot 21DME914
  • Lot 21ABG127
  • Lot 24AMF987
  • Lot 21ABN379
  • Lot 21FBL377
  • Lot 21ABH085
  • Lot 22DBK793
  • Lot 21GBM457
  • Lot 21LBP804
  • Lot 21GMD986
  • Lot 20LMF752
  • Lot 22FBP452
  • Lot 21ABD076
  • Lot 21KBQ655
  • Lot 24ABP679
  • Lot 24BME750
  • Lot 21ABV063
  • Lot 21BDB242
  • Lot 22BBT652
  • Lot 21BDB710
  • Lot 23LBC294
  • Lot 24BBD609
  • Lot 21CDA191
  • Lot 21ABP630
  • Lot 21BMB700
  • Lot 21ABV982
  • Lot 22ADA961
  • Lot 21CBA985
  • Lot 21BBE987
  • Lot 21CDA233
  • Lot 23KMI510
  • Lot 21CBX170
  • Lot 21FBF623
  • Lot 21FBK360
  • Lot 24ABO126
  • Lot 21BDA459
  • Lot 23FMI173
  • Lot 21BDA985
  • Lot 21FMF068
  • Lot 24ABR394
  • Lot 21ALA586
  • Lot 21ADA917
  • Lot 21BBB592
  • Lot 24BBN289
  • Lot 21GBI377
  • Lot 23FBR833
  • Lot 21JBQ304
  • Lot 22KDB751
  • Lot 24ABO130
  • Lot 21CMD153

10 official variants

Affected variants from the official event record
Product or modelCodes and lotsQuantityRecall number
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. CATARACT FULL BODY DYNJ85743 MAJOR VASCULAR PACK DYNJ81610C MINIMALLY INVASIV...DYNJ85743 UDI-DI 10195327542337 Lots 24ABP082 24BBA479 DYNJ81610C UDI-DI 10195327556938 Lot 24BBB405 DYNJ0843063L UDI-DI 10195327567071 Lots 23LDB992 24BDA641 24BDA782 24FDA795 24GDB014 24HDB074 DYNJ54755J UDI-DI 10195327549909 Lots 24ABJ741 24CBI600 24EBA488 24FBM084 24GBN355 24HBH571 DYNJ61383C UDI-DI 10195327593346 Lot 24CLA801 DYNJ0843339O UDI-DI 10195327567057 Lots 24CDB480 24DDA248 24GDB068 DYNJ61907A UDI-DI 10195327542450 Lot 24ABP069 DYNJ0429121L UDI-DI 10195327587697 Lot 24BMH315113,843 kitsZ-2590-2026
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ANGIO PACK DYNJ30565C DYNJ32555B ANGIO PACK-LF DYNJ0774765U ANGIO TRAY DYNJ46...DYNJ30565C UDI-DI 10889942165704 Lots 21CDA555 21DDA970 DYNJ32555B UDI-DI 10884389648216 Lot 21AMA053 DYNJ0774765U UDI-DI 10193489634594 Lot 21FLA468 DYNJ46153A UDI-DI 10889942185863 Lots 20XBH471 21BBC325 DYNJ33638K UDI-DI 10193489343281 Lot 21HLA726 DYNJ35110D UDI-DI 10193489329940 Lot 21IMC537 DYNJ44293D UDI-DI 10193489833416 Lots 21CBE250 21CBX084 21FBB546 21HBD075 21KBN509 22ABV463 22BBX022 22DBJ641 22HBB710 22HBT960 22IBD236 22OBF392 DYNJ0854485T UDI-DI 10193489864199 Lots 21FBC416 21GBL506 21IBO920 21JBS587 DYNJ35916J UDI-DI 10193489838404 Lots 21CBF463 21DBP668 21DBR247 DYNJ57760B UDI-DI 10193489342581 Lots 21CME104 21EME408 21FMD506 21GMG028 21JMF774 21KMH487 DYNJ0842873J UDI-DI 10193489448917 Lots 21ADA204 21CDB566 21EDB709 21GDC532 21HDC041 21JDB401 21JDC566 21LDA726 22BDA893 22CDC138 22EDA075 22FDC040 22HDB149 22JDA080 DYNJ51126A UDI-DI 10193489854886 Lots 21DDA694 21EDB249 21GDD164 21IDA472 21KDA815 DYNJ62858B UDI-DI 10193489891263 Lots 21FMF601 21HMF637 21HMG835 21JMF531 DYNJ51127B UDI-DI 10193489854893 Lot 22FBV791113,843 kitsZ-2591-2026
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. CRANIOTOMY PACK-LF DYNJ0101292F DYNJ0101292G HYBRID PACK DYNJ65925A LAMINECTO...DYNJ0101292F UDI-DI 10193489434040 Lots 21CDC411 21EDA768 21EDC107 21HDA937 21HDC815 21IDC204 21KDA780 22ADA317 22ADC159 22BDA066 22CDA470 22EDB043 22EDB214 22IDA695 DYNJ0101292G UDI-DI 10195327286255 Lots 22KDB031 23BDA768 23DDA637 23EDA187 23HDB829 23JDA057 23LDA727 24ADA469 24ADC048 24HDA453 DYNJ65925A UDI-DI 10193489427264 Lots 21BLA577 21DLA194 21DLA397 DYNJ905156L UDI-DI 10193489397369 Lots 21EBI411 DYNJ905156M UDI-DI 10193489908961 Lots 21HBC497 21HBT672 DYNJ905156N UDI-DI 10193489996371 Lots 21LBQ932 22BBB708 22DBP992 22DBQ776 22FBQ287 DYNJ905156O UDI-DI 10195327219949 Lots 22HBR341 22HBW892 22KBC930 22KBC932 22KBK539 23DBD118 23DBD666 23EBC709 DYNJ905156P UDI-DI 10195327405847 Lots 23GBH099 23GBH829 23GBH830 23HBK732 23JBS610 23JBS704 23LBD615 23LBO186 24ABQ915 24CBD453 DYNJ905159F UDI-DI 10193489397475 Lots 21CBF265 21FBF870 21HBK984 21HBO573 21JBD205 21LBC602 22BBQ673 22CMH568 22EMD159 22GMG564 DYNJ905159I UDI-DI 10195327219987 Lots 22JMF458 22LMH325 23DMI033 23EMF058 DYNJ905159J UDI-DI 10195327406028 Lots 23FMC192 23FMG785 23GMI481 23HMF747 23IMG923 23IMI383 23JMA274 DYNJ905159K UDI-DI 10195327556884 Lots 23LMF481 24BMA401 24CMJ402 DYNJ0101287J UDI-DI 10195327286484 Lots 23ADA628 23EDA927 23GDA587 23HDC199 DYNJ0101287K UDI-DI 10195327500177 Lot 23JDC525 DYNJ81612C UDI-DI 10195327536145 Lot 24BBB406 DYNJ0843339L UDI-DI 10193489345544 Lots 21EDC223 21FDB611 DYNJ0843339M UDI-DI 10193489964615 Lots 21HDB435 21IDB916 21KDC093 22BDA178 22DDA738 22EDA069 22EDB876 22HDC322 22JDA142 22KDB701 DYNJ0843339N UDI-DI 10195327286552 Lots 23ADA251 23BDB752 23DDB611 23FDA191 23HDB830 23IDB329 23JDA990 23LDA449 DYNJ30150F UDI-DI 10889942186679 Lot 24BBE416113,843 kitsZ-2587-2026
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ANGIO CATH COMBINED PACK DYNJ43609S ANGIO PACK DYNJ67987D DYNJ80317A ANGIO SP...DYNJ43609S UDI-DI 10195327322984 Lot 23BMG740; DYNJ67987D UDI-DI 10195327265496 Lot 22LMI014; DYNJ80317A UDI-DI 10195327410780 Lot 23JLA076 DYNJ38412C UDI-DI 10195327291792 Lot 24CME277 DYNJ66260A UDI-DI 10195327185749 Lot 22GMH445 DYNJ44293I UDI-DI 10198459152108 Lots 24JBX196 24KBJ077 24LBF062 24LBP058 DYNJ0854485W UDI-DI 10195327403430 Lot 23EMI244 DYNJ82709 UDI-DI 10195327202590 Lots 22KBG072 23ABM307 23ABR612 DYNJ0261554AL UDI-DI 10195327467760 Lot 23IMA846 DYNJ31103F UDI-DI 10195327461317 Lots 23ILA143 23JLA420 23KLB055 23LLA790 24ALA692 24BLA009 24BLA835 24CLA859 24ELA213 24ELA684 24FLA287 24GLA266 24HLA117 24HLB121 24JLA570 24KLB094 24LLA468 25ALA377 DYNJ83506 UDI-DI 10195327272890 Lot 22LBM317 DYNJ66366C UDI-DI 10195327232887 Lots 22HME111 22IME517 22JMF050 22LMH296 23DMD313 23EMF238 23FMH270 23GMF506 23HME060 SAMPC0686 UDI-DI 10195327195489 Lot 22HDA577 DYNJ63434B UDI-DI 10195327335502 Lots 23CBG406 23CBU167 23DBT002 23EBS228 DYNJ907758B UDI-DI 10195327181000 Lot 22GBD778 DYNJ80925B UDI-DI 10195327624903 Lot 24CBG978113,843 kitsZ-2582-2026
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ANGIO DRAPE PACK (ADLUG)642-LF DYNJ47665D ANGIO PACK DYNJ30565D ANGIOGRAPHY P...DYNJ47665D UDI-DI 10193489952827 Lots 21HBJ571 21JBD819 21LBA976 22BBP310 22CBW541 22CMH003 22DMD476 22EMA241 22FMF056 22HMC694 22HME818 22IMC158 22IMG796 22JMD311 22LMD944 22NBC196 23AMB219 DYNJ30565D UDI-DI 10193489905205 Lots 21FDB653 21GDB275 DYNJ0854485V UDI-DI 10195327096885 Lots 22CMB440 22EMF763 22HMA699 22HMG186 22IMD134 22LME930 23BMC883 23CMB807 23CMI020 DYNJ28082D UDI-DI 10193489268676 Lots 21ABN806 21BBP110 21DBL217 21EBS784 21FBU514 DYNJ28082F UDI-DI 10193489949452 Lots 21HBM290 21IBQ174 21KBO096 21KBO098 DYNJ67349 UDI-DI 10193489895728 Lots 23JMA721 24BMF147 DYNJ57874C UDI-DI 10193489976618 Lot 24ABM611 DYNJSCL100 UDI-DI 10884389625583 Lot 24ABM801 DYNJSCL300 UDI-DI 10884389625606 Lot 24ABM802 DYNJ50779F UDI-DI 10193489436068 Lots 21DME914 21EMF097 21GMB502 21JMA420 22BMA533 22BMB246 22DMA002 22DMD984 22DMI243 22EMG746 22GMB725 22HMH063 22IME310 22KMA626 23AME217 23BME137 23DMH595 23EMI849 23FMJ773 23JMB530 23LMH087 24BMF696 24CMJ355 24DMA986 DYNJ41088B UDI-DI 10889942632794 Lot 21ABG127 DYNJ48085 UDI-DI 10888277546035 Lot 24AMF987 DYNJ37389N UDI-DI 10193489306019 Lots 21ABN379 21CBU277 21DBP810 DYNJ37389O UDI-DI 10193489925302 Lots 21FBL377 21GBD005 21HBN337 21JBW141 21JBW142 21LBG627 22ABH544 22CBF313 22DBD511 22DBE512 22FBS027 DYNJ62595A UDI-DI 10193489364262 Lots 21ABH085 21ABI181 21ABV975 21BBO277 21CBU091 21EBA810 DYNJ69997 UDI-DI 10195327004743 Lots 22DBK793 22IBD718 22IBE297 22OBC253 DYNJ47645B UDI-DI 10193489952834 Lots 21GBM457 21IBV915 21KBF627 21LBA512 21LME436 22DMI445 22EMD836 22FMC418 22GME258 22KMD663 DYNJ67918A UDI-DI 10195327042776 Lots 21LBP804 22CBZ026 22CBZ027 22OBG779 DYNJ56666C UDI-DI 10193489876079 Lots 21GMD986 21IMF632 21KMI417 22BMG174 22EMC819 22GMA609 22HMB858 22IME607 22JMI267 22LMA954 22LMH272 23BMH725 DYNJ44100L UDI-DI 10193489808810 Lots 20LMF752 21AMD830 21BMB938 21DMB287 21FMA141 21GMF673 21HMF024 21JMH879 21LMD528 22AME658 22CMD992 22DME753 22EMI131 22FMD999 22GMA910 22HMG804 22KMC260 22LMF595 DYNJ43664 UDI-DI 10888277065475 Lot 22FBP452 DYNJ0516014AF UDI-DI 10193489346978 Lots 21ABD076 21FBH595 21HBP277 21IBX390 21KBK660 22BBF662 22CBA986 22CBQ787 22DBI149 22FMC751 22FMF379 22IMA038 22IMH722 DYNJ907758A UDI-DI 10193489978384 Lot 21KBQ655 DYNJ62376A UDI-DI 10193489933598 Lot 24ABP679113, 843 kitsZ-2592-2026
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. AAA DYNJ905651B ARTERIOGRAM TRAY 00-402001S AV SHUNT PACK-LF DYNJ0842516F BAS...DYNJ905651B UDI-DI 10193489925067 Lot 24BME750 00-402001S UDI-DI 10889942893645 Lots 21ABV063 21BBK296 21OBA437 DYNJ0842516F UDI-DI 10193489352375 Lots 21BDB242 21CDC063 21HDB970 21IDB395 21KDC355 22BDA157 22DDB628 22FDA331 22GDB353 PHS463660F UDI-DI 10195327096991 Lots 22BBT652 22DBK236 DYNJ43580C UDI-DI 10889942249398 Lots 21BDB710 21DDB799 DYNDA2213A UDI-DI 10889942925421 Lots 23LBC294 DYNJ65277A UDI-DI 10193489409536 Lots 24BBD609 24BBD609A DYNJ0842793F UDI-DI 10193489345230 Lots 21CDA191 21CDC092 21EDA769 21GDB289 21HDC822 22BDB295 22DDA792 22EDB725 22IDC164 DYNJ67918 UDI-DI 10193489459081 Lots 21ABP630 21DBL459 21EBD905 21HBE280 21HBE285 21IBS959 21VBD188 DYNJ56666B UDI-DI 10888277740273 Lots 21BMB700 21CMA789 DYNJ44123A UDI-DI 10889942952977 Lots 21ABV982 21CBB916 21HBQ740 21KBE936 21VBC816 22ABS461 22CBX354 22DBD608 22EBT322 22GBR526 22HBS119 22LBA937 22LBM278 23ABJ758 23BBG292 23CBD680 DYNJ51126B UDI-DI 10195327044138 Lots 22ADA961 22BDC241 22DDA320 22DDB652 22FBD047 22FBH293 22HBQ223 22HBY535 22JBG518 PAIN1454 UDI-DI 10193489688863 Lots 21CBA985 21DBU969 21FBN495 21GBG636 21KBJ919 22ABJ583 22BBN243 22IBT753 22KBA570 23ABK226 23IBE552 23JBF419 23KBJ152 DYNJ905160I UDI-DI 10193489397482 Lots 21BBE987 21DBD058 21EBC916 DYNJ0843063J UDI-DI 10193489345377 Lots 21CDA233 21EDC220 21GDC682 21IDA570 21JDA064 21LDA151 22ADC136 22CDB166 22EDA616 22FDB836 22HDB150 22KDA481 DYNJ37304F UDI-DI 10889942727919 Lot 23KMI510 DYNJ56386B UDI-DI 10888277762886 Lots 21CBX170 21GBQ837 21JBW253 21LBH797 22ABX259 22BBC246 22CBW026 22DBU970 22GBA195 22HBL094 22LBH829 23ABG503 23ABO274 23BBO056 23DBQ675 23FBQ670 23HBV115 23JBC749 23JBP144 DYNJ907758 UDI-DI 10193489872002 Lot 21FBF623 DYNJ40952 UDI-DI 10884389898826 Lot 21FBK360 DYNJ60715 UDI-DI 10193489520279 Lot 24ABO126 DYNJ37484B UDI-DI 10889942777792 Lots 21BDA459 21DDA549 21DDB648 21GDC975 21IDB972 21JDC475 21LDB205 22ADC256 22BDB581 22FDA100 22GDB220 22IDB953 22KDB836 23ADA661 23CDB420 23DDC200 DYNJ908706A UDI-DI 10195327406042 Lots 23FMI173 23GMB991 23HMF410 23IMF032 DYNJ0101339J UDI-DI 10193489472516 Lots 21BDA985 21DDB919 21GDD035 21HDC817 21KDA162 22ADA293 22BDB849 22EDB044 22HDB148 22IDC162 DYNJ69090 UDI-DI 10193489883596 Lots 21FMF068 22EMB610 DYNJ56260B UDI-DI 10193489569827 Lots 24ABR394113,843 kitsZ-2585-2026
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ANGIOGRAM PACK-LF DYNJ21574J JUDKINS PACK DYNJ51126DYNJ21574J UDI-DI 10889942153497 Lots 21ALA586 21CLA398 21ELA408 21FLA144 21FLA788 21HLA420 21ILA431 DYNJ51126 UDI-DI 10889942122820 Lots 21ADA917113,843 kitsZ-2581-2026
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. CENTRAL LINE TRAY DYNJ41089 FISTULAGRAM PACK DYNJ62827A FISTULOGRAM PACK DYNJ...DYNJ41089 UDI-DI 10884389891360 Lot 21BBB592 DYNJ62827A UDI-DI 10193489306606 Lot 24BBN289 DYNJ47899A UDI-DI 10889942574681 Lots 21GBI377 21IBL299 21LBE099 21LBU529 22JBV803 DYNJ44123B UDI-DI 10195327381653 Lots 23FBR833 23GBN041 23HBW014 23JBO264 23JBW218 23KBI873 DYNJ68037A UDI-DI 10195327003630 Lots 21JBQ304 21LBQ205 22ABN185 22DBT349 22EBL611 22HBH550 22IBN880 22JBH689 22KBS987 22OBA368 23ABD642 23BBH830 23DBL865 23EBT367 23FBM946 23GBT261 DYNJ0101291F UDI-DI 10195327286644 Lots 22KDB751 23EDA119 23EDB388 23FDA396 23GDA313 23HDA759 23LDB909 24ADB667 24GDA294 24HDB515113, 843 kitsZ-2594-2026
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. MAJOR BASIN SET DYNJ85723DYNJ85723 UDI-DI 10195327538491 Lot 24ABO130113,843 kitsZ-2588-2026
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. PICC LINEPACK (PCLUI)642-LF DYNJ47717ADYNJ47717A UDI-DI 10193489454529 Lots 21CMD153 21EMC033 21HMB521 21HMF278 21IME100 21IMG896 21JMG286 22AME235 22BMH056 22EMF125 22GMI215 22JME782 22LMC139 22LMC336113, 843 kitsZ-2595-2026

2What is the risk?

The agency's statement is shown without a site-authored severity score.

Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.

Agency classification: Class II

3What should I do?

Only instructions associated with this recall event qualify as an action.

Consumer action is not available in the associated official record. The site does not infer or generate a replacement.

Verify on the official source

The linked agency record controls if any information differs.

Official evidence

Official scope

Distribution reported by the agency

US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IL, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, TN, TX, VA, WI, WY and the country of Barbados.

Distribution is context, not a confirmed item match. Compare the model, lot, UPC, NDC, or serial number above.

Material change history

  • : affectedSummary changed in the official record.