Class 2 Device Recall Medline

• Date Initiated by Firm: February 11, 2025
• Date Posted: March 26, 2025
• Recall Status: Open, Classified
• Recall Number: Z-1465-2025
• Recall Event ID: 96373
• Product Classification: Orthopedic tray - Product Code OJH
• Product: Medline procedure kits labeled as: 1) ACL ARTHROSCOPY PACK, Pack Number DYNJ55316G; 2) ARTERIOGRAM PACK, Pack Number DYNJ64332; 3) ARTHRO PACK-LF, Pack Number DYNJ38748F; 4) ARTHRO PACK-LF, Pack Number DYNJ38748F; 5) ARTHROGRAM PACK, Pack Number DYNJ65817; 6) ARTHROGRAM TRAY, Pack Number DYNDH1937; 7) ARTHROSCOPY KNEE PACK-LF, Pack Number DYNJ0809731F; 8) ARTHROSCOPY PACK, Pack Number DYNJ66665; 9) ARTHROSCOPY PACK, Pack Number DYNJ38716C; 10) ARTHROSCOPY PACK, Pack Number DYNJ33639J; 11) ARTHROSCOPY PACK, Pack Number DYNJ37707D; 12) ARTHROSCOPY PACK, Pack Number DYNJ38914A; 13) ARTHROSCOPY PACK, Pack Number DYNJ64526A; 14) ARTHROSCOPY PACK, Pack Number DYNJ62755B; 15) ARTHROSCOPY PACK, Pack Number DYNJ61634B; 16) ARTHROSCOPY PACK, Pack Number DYNJ83129; 17) ARTHROSCOPY PACK, Pack Number DYNJ35906F; 18) ARTHROSCOPY PACK, Pack Number DYNJ35906F; 19) ARTHROSCOPY PACK, Pack Number DYNJ37946C; 20) ARTHROSCOPY PACK, Pack Number DYNJ68133A; 21) ARTHROSCOPY PACK BCS, Pack Number DYNJ45629B; 22) ARTHROSCOPY PACK -LF, Pack Number DYNJ0781838S; 23) ARTHROSCOPY PACK-LF, Pack Number DYNJ80469B; 24) ARTHROSCOPY PACK-SHOULDER, Pack Number DYNJ04452L; 25) ARTHROSCOPY PACK-SHOULDER, Pack Number DYNJ24507G; 26) ARTHROSCOPY TRAY, Pack Number DYNJ65948A; 27) ARTHROSCOPY TRAY, Pack Number DYNJ81547; 28) BACK PACK-LF, Pack Number DYNJ0381507N; 29) BASIC ORTHO PACK, Pack Number DYNJ67212A; 30) BASIC SPINE PACK-LF, Pack Number DYNJ39199F; 31) CLOVIS LOWER EXTREMITY-LF, Pack Number DYNJ61066C; 32) CRANIOTOMY PACK, Pack Number DYNJ45145G; 33) CRANIOTOMY PACK-LF, Pack Number DYNJ0530906AO; 34) CRANIOTOMY PACK-LF, Pack Number DYNJ38351O; 35) DL-KNEE SCOPE, Pack Number DYNJ67595B; 36) ENSEMBLE CRANIOTOMIE-LF, Pack Number DYNJ29202D; 37) ESC HAND PACK, Pack Number DYNJ42264; 38) EXTREMITY, Pack Number DYNJ52017; 39) EXTREMITY PACK, Pack Number DYNJ64167D; 40) EXTREMITY PACK, Pack Number DYNJ52104A; 41) EXTREMITY PACK, Pack Number DYNJ53915D; 42) EXTREMITY PACK, Pack Number DYNJ35046B; 43) EXTREMITY PACK, Pack Number DYNJ83732; 44) EXTREMITY PACK, Pack Number DYNJ54684B; 45) EXTREMITY PACK-BELVIDERE, Pack Number DYNJ44692D; 46) EXTREMITY/TRAUMA PACK-LF, Pack Number DYNJ0190688Q; 47) FAIRFIELD KNEE-LF, Pack Number DYNJ30196F; 48) FH PODIATRY PACK-LF, Pack Number DYNJ51796G; 49) FHWC EXTREMITY PACK, Pack Number DYNJ39734D; 50) FOOT AND ANKLE PACK, Pack Number DYNJ65319B; 51) GENERAL ORTHO PACK-LF, Pack Number DYNJ0781892X; 52) GP ARTHROSCOPY KNEE PACK-LF, Pack Number DYNJ0163462Y; 53) GSC KNEE ARTHROSCOPY, Pack Number DYNJ908637; 54) HAND NO SPONGE NOBASIN NOBOWL, Pack Number DYNJ68906; 55) HAND PACK, Pack Number DYNJ44076B; 56) HAND PACK, Pack Number DYNJ60203; 57) HAND PACK, Pack Number DYNJ42329G; 58) HAND PACK, Pack Number DYNJ43386; 59) HAND PACK, Pack Number DYNJ38715C; 60) HAND PACK, Pack Number DYNJ51930A; 61) HAND PACK, Pack Number DYNJ56195C; 62) HAND PACK, Pack Number DYNJ48236I; 63) HAND PACK, Pack Number DYNJ82784; 64) HAND PACK, Pack Number DYNJ55283D; 65) HAND PACK, Pack Number DYNJ44084D; 66) HAND PACK, Pack Number DYNJ46978B; 67) HAND PACK, Pack Number DYNJ81283; 68) HAND PACK, Pack Number DYNJ69908A; 69) HAND PACK XM-LF, Pack Number DYNJ39828D; 70) HAND PACK-LF, Pack Number DYNJ04606G; 71) HAND PACK-LF, Pack Number DYNJ0773815M; 72) HAND PACK-LF, Pack Number DYNJ59960B; 73) HAND/ELBOW PACK, Pack Number DYNJ52097F; 74) HIP PACK, Pack Number DYNJ23762L; 75) HL ACL PACK, Pack Number DYNJ40357C; 76) JOS KNEE PACK, Pack Number PHS977014AK; 77) KNEE ARTH PACK, Pack Number DYNJ83854A; 78) KNEE ARTHROSCOPY, Pack Number DYNJ50313A; 79) KNEE ARTHROSCOPY, Pack Number DYNJ64208; 80) KNEE ARTHROSCOPY PACK, Pack Number DYNJ50682B; 81) KNEE ARTHROSCOPY PACK, Pack Number DYNJ61581A; 82) KNEE ARTHROSCOPY PACK, Pack Number DYNJ41162; 83) KNEE ARTHROSCOPY PACK, Pack Number DYNJ48237J; 84) KNEE ARTHROSCOPY PACK, Pack Number DYNJ39184B; 85) KNEE ARTHROSCOPY PACK, Pack Number D
• Code Information: 1) Pack Number DYNJ55316G: UDI/DI 10889942278022 (each) 40889942278023 (case), Lot Number 20BDA583A; 2) Pack Number DYNJ64332: UDI/DI 10889942692262 (each) 40889942692263 (case), Lot Number 20BDB394A; 3) Pack Number DYNJ38748F: UDI/DI 10193489275063 (each) 40193489275064 (case), Lot Number 20BDB587A; 4) Pack Number DYNJ38748F: UDI/DI 10889942524334 (each) 40889942524335 (case), Lot Number 20BDB606A; 5) Pack Number DYNJ65817: UDI/DI 10193489744910 (each) 40193489744911 (case), Lot Number 20EBL095A; 6) Pack Number DYNDH1937: UDI/DI 10193489773088 (each) 40193489773089 (case), Lot Number 20FBS286Z; 7) Pack Number DYNJ0809731F: UDI/DI 10193489369892 (each) 40193489369893 (case), Lot Number 20FBS559A; 8) Pack Number DYNJ66665: UDI/DI 10888277546394 (each) 40888277546395 (case), Lot Number 20FMA565A; 9) Pack Number DYNJ38716C: UDI/DI 10193489706796 (each) 40193489706797 (case), Lot Number 20GBA802Z; 10) Pack Number DYNJ33639J: UDI/DI 10193489783247 (each) 40193489783248 (case), Lot Number 20GKA136A; 11) Pack Number DYNJ37707D: UDI/DI 10193489258936 (each) 40193489258937 (case), Lot Number 20HKB321A; 12) Pack Number DYNJ38914A: UDI/DI 10193489265651 (each) 40193489265652 (case), Lot Number 20HKB355A; 13) Pack Number DYNJ64526A: UDI/DI 10193489531589 (each) 40193489531580 (case), Lot Number 20HMC644A; 14) Pack Number DYNJ62755B: UDI/DI 10193489296792 (each) 40193489296793 (case), Lot Number 20HMD066A; 15) Pack Number DYNJ61634B: UDI/DI 10888277756168 (each) 40888277756169 (case), Lot Number 20HMD167A; 16) Pack Number DYNJ83129: UDI/DI 10193489366815 (each) 40193489366816 (case), Lot Number 20JKA848A; 17) Pack Number DYNJ35906F: UDI/DI 10193489718577 (each) 40193489718578 (case), Lot Number 20LBI228Z; 18) Pack Number DYNJ35906F: UDI/DI 10193489397598 (each) 40193489397599 (case), Lot Number 20LBS935Z; 19) Pack Number DYNJ37946C: UDI/DI 10193489338829 (each) 40193489338820 (case), Lot Number 20LKB368A; 20) Pack Number DYNJ68133A: UDI/DI 10193489408188 (each) 40193489408189 (case), Lot Number 20LMF345A; 21) Pack Number DYNJ45629B: UDI/DI 10193489354010 (each) 40193489354011 (case), Lot Number 21ABK027A; 22) Pack Number DYNJ0781838S: UDI/DI 10193489509175 (each) 40193489509176 (case), Lot Number 21AMA194A; 23) Pack Number DYNJ80469B: UDI/DI 10889942935567 (each) 40889942935568 (case), Lot Number 21AMA323A; 24) Pack Number DYNJ04452L: UDI/DI 10193489408034 (each) 40193489408035 (case), Lot Number 21AMA358A; 25) Pack Number DYNJ24507G: UDI/DI 10193489443387 (each) 40193489443388 (case), Lot Number 21AMA575A; 26) Pack Number DYNJ65948A: UDI/DI 10889942794942 (each) 40889942794943 (case), Lot Number 21AMA586A; 27) Pack Number DYNJ81547: UDI/DI 10889942954957 (each) 40889942954958 (case), Lot Number 21AMA587A; 28) Pack Number DYNJ0381507N: UDI/DI 10193489422511 (each) 40193489422512 (case), Lot Number 21BBB671A; 29) Pack Number DYNJ67212A: UDI/DI 10193489662825 (each) 40193489662826 (case), Lot Number 21BBF422A; 30) Pack Number DYNJ39199F: UDI/DI 10193489733631 (each) 40193489733632 (case), Lot Number 21BBF515A; 31) Pack Number DYNJ61066C: UDI/DI 10193489845983 (each) 40193489845984 (case), Lot Number 21CBB429A; 32) Pack Number DYNJ45145G: UDI/DI 10193489685046 (each) 40193489685047 (case), Lot Number 21EBL376Z; 33) Pack Number DYNJ0530906AO: UDI/DI 10193489869040 (each) 40193489869041 (case), Lot Number 21EBL427A; 34) Pack Number DYNJ38351O: UDI/DI 10193489295160 (each) 40193489295161 (case), Lot Number 21EBM957A; 35) Pack Number DYNJ67595B: UDI/DI 10193489551488 (each) 40193489551489 (case), Lot Number 21GMB024A; 36) Pack Number DYNJ29202D: UDI/DI 10889942008476 (each) 40889942008477 (case), Lot Number 21GMB048A; 37) Pack Number DYNJ42264: UDI/DI 10889942598595 (each) 40889942598596 (case), Lot Number 21HMA483A; 38) Pack Number DYNJ52017: UDI/DI 10884389918845 (each) 40884389918846 (case), Lot Number 21HMA492A; 39) Pack Number DYNJ64167D: UDI/DI 10888277048713 (each) 40888277048714 (case), Lot Number 21HMA631A; 40) Pack Number DYNJ52104A: UDI/DI 10193489567618 (each) 40193489567619 (case), Lot Number 21IMC899A; 41) Pack Number DYNJ53915D: UDI/DI 10889942487493 (each) 40889942487494 (case), Lot Number 21IMD192A; 42) Pack Number DYNJ35046B: UDI/DI 10193489867442 (each) 40193489867443 (case), Lot Number 21IMD397A; 43) Pack Number DYNJ83732: UDI/DI 10193489822564 (each) 40193489822565 (case), Lot Number 21IMD680A; 44) Pack Number DYNJ54684B: UDI/DI 10193489551068 (each) 40193489551069 (case), Lot Number 21IMD870A; 45) Pack Number DYNJ44692D: UDI/DI 10193489909869 (each) 40193489909860 (case), Lot Number 21IME024A; 46) Pack Number DYNJ0190688Q: UDI/DI 10193489322644 (each) 40193489322645 (case), Lot Number 21IME395A; 47) Pack Number DYNJ30196F: UDI/DI 10193489976625 (each) 40193489976626 (case), Lot Number 21IME728A; 48) Pack Number DYNJ51796G: UDI/DI 10889942651887 (each) 40889942651888 (case), Lot Number 21IME769A; 49) Pack Number DYNJ39734D: UDI/DI 10193489303940 (each) 40193489303941 (case), Lot Number 21IMH101A; 50) Pack Number DYNJ65319B: UDI/DI 10193489249408 (each) 40193489249409 (case), Lot Number 21IMH684A; 51) Pack Number DYNJ0781892X: UDI/DI 10193489885224 (each) 40193489885225 (case), Lot Number 21JMA112A; 52) Pack Number DYNJ0163462Y: UDI/DI 10193489696806 (each) 40193489696807 (case), Lot Number 21JMA224A; 53) Pack Number DYNJ908637: UDI/DI 10193489285031 (each) 40193489285032 (case), Lot Number 21JMG397A; 54) Pack Number DYNJ68906: UDI/DI 10889942862351 (each) 40889942862352 (case), Lot Number 21JMH039A; 55) Pack Number DYNJ44076B: UDI/DI 10193489793925 (each) 40193489793926 (case), Lot Number 21JMH310A; 56) Pack Number DYNJ60203: UDI/DI 10193489561265 (each) 40193489561266 (case), Lot Number 21JMH499A; 57) Pack Number DYNJ42329G: UDI/DI 10193489242911 (each) 40193489242912 (case), Lot Number 21JMH911A; 58) Pack Number DYNJ43386: UDI/DI 10193489857269 (each) 40193489857260 (case), Lot Number 21JMH954A; 59) Pack Number DYNJ38715C: UDI/DI 10193489551464 (each) 40193489551465 (case), Lot Number 21JMI026A; 60) Pack Number DYNJ51930A: UDI/DI 10889942113576 (each) 40889942113577 (case), Lot Number 21JMI088A; 61) Pack Number DYNJ56195C: UDI/DI 10193489942019 (each) 40193489942010 (case), Lot Number 21JMI118A; 62) Pack Number DYNJ48236I: UDI/DI 10193489290271 (each) 40193489290272 (case), Lot Number 21KBA904A; 63) Pack Number DYNJ82784: UDI/DI 10193489717716 (each) 40193489717717 (case), Lot Number 21KBA968A; 64) Pack Number DYNJ55283D: UDI/DI 10889942010622 (each) 40889942010623 (case), Lot Number 21KBB026A; 65) Pack Number DYNJ44084D: UDI/DI 10193489904222 (each) 40193489904223 (case), Lot Number 21KBP900A; 66) Pack Number DYNJ46978B: UDI/DI 10889942374120 (each) 40889942374121 (case), Lot Number 21LBA799A; 67) Pack Number DYNJ81283: UDI/DI 10193489413625 (each) 40193489413626 (case), Lot Number 21LBC989A; 68) Pack Number DYNJ69908A: UDI/DI 10193489475326 (each) 40193489475327 (case), Lot Number 21LBE566A; 69) Pack Number DYNJ39828D: UDI/DI 10193489899542 (each) 40193489899543 (case), Lot Number 21LBK207A; 70) Pack Number DYNJ04606G: UDI/DI 10193489594966 (each) 40193489594967 (case), Lot Number 21LME600A; 71) Pack Number DYNJ0773815M: UDI/DI 10193489858389 (each) 40193489858380 (case), Lot Number 21LMF094A; 72) Pack Number DYNJ59960B: UDI/DI 10888277842380 (each) 40888277842381 (case), Lot Number 21LMF225A; 73) Pack Number DYNJ52097F: UDI/DI 10193489997828 (each) 40193489997829 (case), Lot Number 21LMF355A; 74) Pack Number DYNJ23762L: UDI/DI 10193489490657 (each) 40193489490658 (case), Lot Number 22CMA539Z; 75) Pack Number DYNJ40357C: UDI/DI 10193489360349 (each) 40193489360340 (case), Lot Number 22CMB034A; 76) Pack Number PHS977014AK: UDI/DI 10193489226034 (each) 40193489226035 (case), Lot Number 22CMB661A; 77) Pack Number DYNJ83854A: UDI/DI 10193489879506 (each) 40193489879507 (case), Lot Number 22DBL673Z; 78) Pack Number DYNJ50313A: UDI/DI 10193489859041 (each) 40193489859042 (case), Lot Number 22DBP324Z; 79) Pack Number DYNJ64208: UDI/DI 10193489917703 (each) 40193489917704 (case), Lot Number 22FBW094A; 80) Pack Number DYNJ50682B: UDI/DI 10195327048624 (each) 40195327048625 (case), Lot Number 22FMH908A; 81) Pack Number DYNJ61581A: UDI/DI 10193489610970 (each) 40193489610971 (case), Lot Number 22FMH912Z; 82) Pack Number DYNJ41162: UDI/DI 10195327140823 (each) 40195327140824 (case), Lot Number 22GBD833Z; 83) Pack Number DYNJ48237J: UDI/DI 10193489688436 (each) 40193489688437 (case), Lot Number 22GBJ269A; 84) Pack Number DYNJ39184B: UDI/DI 10193489484397 (each) 40193489484398 (case), Lot Number 22GBJ318A; 85) Pack Number DYNJ34403I: UDI/DI 10195327177027 (each) 40195327177028 (case), Lot Number 22GBJ780A; 86) Pack Number DYNJ04598G: UDI/DI 10193489226584 (each) 40193489226585 (case), Lot Number 22GBK197Z; 87) Pack Number DYNJ34270D: UDI/DI 10195327153601 (each) 40195327153602 (case), Lot Number 22GBK206A; 88) Pack Number DYNJ43522C: UDI/DI 10195327176310 (each) 40195327176311 (case), Lot Number 22GBL783M; 89) Pack Number DYNJ59765A: UDI/DI 10195327155780 (each) 40195327155781 (case), Lot Number 22GBM456Z; 90) Pack Number DYNJ83035: UDI/DI 10195327033835 (each) 40195327033836 (case), Lot Number 22GBN347A; 91) Pack Number DYNJ59251B: UDI/DI 10889942784264 (each) 40889942784265 (case), Lot Number 22GBN373Z; 92) Pack Number DYNJ43556: UDI/DI 10889942932436 (each) 40889942932437 (case), Lot Number 22GBN380M; 93) Pack Number DYNJ0890502O: UDI/DI 10193489471472 (each) 40193489471473 (case), Lot Number 22GBO057Z; 94) Pack Number DYNJ908186A: UDI/DI 10193489269130 (each) 40193489269131 (case), Lot Number 22GBQ187M; 95) Pack Number DYNJ64043A: UDI/DI 10884389906682 (each) 40884389906683 (case), Lot Number 22GBQ251M; 96) Pack Number DYNJ57022: UDI/DI 10193489962765 (each) 40193489962766 (case), Lot Number 22GBT219Z; 97) Pack Number DYNJ906981A: UDI/DI 10195327122300 (each) 40195327122301 (case), Lot Number 22GBU893M; 98) Pack Number DYNJ40296B: UDI/DI 10195327122850 (each) 40195327122851 (case), Lot Number 22GBW635A; 99) Pack Number DYNJ69401B: UDI/DI 10193489259223 (each) 40193489259224 (case), Lot Number 22GBX568A; 100) Pack Number DYNJ54965: UDI/DI 10889942275069 (each) 40889942275060 (case), Lot Number 22GMA060Z; 101) Pack Number DYNJ44001C: UDI/DI 10195327081331 (each) 40195327081332 (case), Lot Number 22GMA578A; 102) Pack Number DYNJ59047: UDI/DI 10193489915563 (each) 40193489915564 (case), Lot Number 22GMA607A; 103) Pack Number DYNJ66657B: UDI/DI 10193489404524 (each) 40193489404525 (case), Lot Number 22GMA869A; 104) Pack Number DYNJ906950A: UDI/DI 10193489988178 (each) 40193489988179 (case), Lot Number 22GMB078Z; 105) Pack Number DYNJ906023D: UDI/DI 10193489988185 (each) 40193489988186 (case), Lot Number 22GMB085A; 106) Pack Number DYNJ906199: UDI/DI 10193489589603 (each) 40193489589604 (case), Lot Number 22GMB388A; 107) Pack Number DYNJ43459B: UDI/DI 10193489949414 (each) 40193489949415 (case), Lot Number 22GMB719Z; 108) Pack Number DYNJ57742G: UDI/DI 10193489900996 (each) 40193489900997 (case), Lot Number 22GMB754A; 109) Pack Number DYNJ64289F: UDI/DI 10193489422603 (each) 40193489422604 (case), Lot Number 22GMC396Z; 110) Pack Number DYNJ0854794J: UDI/DI 10195327093969 (each) 40195327093960 (case), Lot Number 22GMC438A; 111) Pack Number DYNJ66618: UDI/DI 10889942920358 (each) 40889942920359 (case), Lot Number 22GMC550Z; 112) Pack Number DYNJ69926A: UDI/DI 10195327112837 (each) 40195327112838 (case), Lot Number 22GMC943Z; 113) Pack Number DYNJ908009A: UDI/DI 10195327176433 (each) 40195327176434 (case), Lot Number 22GMD094Z; 114) Pack Number DYNJ04770N: UDI/DI 10193489393675 (each) 40193489393676 (case), Lot Number 22GMD982Z; 115) Pack Number DYNJ67673: UDI/DI 10193489371253 (each) 40193489371254 (case), Lot Number 22GME633Z; 116) Pack Number DYNJ48718D: UDI/DI 10195327112929 (each) 40195327112920 (case), Lot Number 22GME720Z; 117) Pack Number DYNJ57981A: UDI/DI 10195327238506 (each) 40195327238507 (case), Lot Number 22IBG401M; 118) Pack Number DYNJ28463L: UDI/DI 10195327216474 (each) 40195327216475 (case), Lot Number 22IBM797M; 119) Pack Number DYNJ46490L: UDI/DI 10195327144647 (each) 40195327144648 (case), Lot Number 22IME822A; 120) Pack Number DYNJ58706B: UDI/DI 10193489284270 (each) 40193489284271 (case), Lot Number 22JBD663Z; 121) Pack Number DYNJ0155576M: UDI/DI 10193489284270 (each) 40193489284271 (case), Lot Number 22JBD664Z; 122) Pack Number DYNJ56484D: UDI/DI 10195327164447 (each) 40195327164448 (case), Lot Number 22JBD797Z; 123) Pack Number DYNJ61943: UDI/DI 10195327177157 (each) 40195327177158 (case), Lot Number 22JBG780Z; 124) Pack Number DYNJ0826438T: UDI/DI 10195327128289 (each) 40195327128280 (case), Lot Number 22JBH375Z; 125) Pack Number DYNJ33178I: UDI/DI 10193489895643 (each) 40193489895644 (case), Lot Number 22JBH847Z; 126) Pack Number DYNJ53738B: UDI/DI 10195327129330 (each) 40195327129331 (case), Lot Number 22JBK292Z; 127) Pack Number DYNJ0438479C: UDI/DI 10195327225018 (each) 40195327225019 (case), Lot Number 22JBM073Z; 128) Pack Number DYNJ56896: UDI/DI 10195327222482 (each) 40195327222483 (case), Lot Number 22JBN584Z; 129) Pack Number DYNJ45042C: UDI/DI 10193489413311 (each) 40193489413312 (case), Lot Number 22JBQ352Z; 130) Pack Number DYNJ47036D: UDI/DI 10195327233167 (each) 40195327233168 (case), Lot Number 22JBR942Z; 131) Pack Number DYNJ45892C: UDI/DI 10193489920116 (each) 40193489920117 (case), Lot Number 22JBS220Z; 132) Pack Number DYNJ65596A: UDI/DI 10889942233090 (each) 40889942233091 (case), Lot Number 22LBC930A; 133) Pack Number DYNJ59731A: UDI/DI 10195327150549 (each) 40195327150540 (case), Lot Number 22LBD041A; 134) Pack Number DYNJ36689G: UDI/DI 10193489581294 (each) 40193489581295 (case), Lot Number 22LBD072A; 135) Pack Number DYNJ47653I: UDI/DI 10193489486193 (each) 40193489486194 (case), Lot Number 22LDA323A; 136) Pack Number DYNJ47647K: UDI/DI 10193489389975 (each) 40193489389976 (case), Lot Number 23BBH720A; 137) Pack Number DYNJ43965A: UDI/DI 10193489286182 (each) 40193489286183 (case), Lot Number 23BBQ877A; 138) Pack Number DYNJ57538A: UDI/DI 10195327291082 (each) 40195327291083 (case), Lot Number 23BBR471A; 139) Pack Number DYNJ53436D: UDI/DI 10193489814538 (each) 40193489814539 (case), Lot Number 23BBS147A; 140) Pack Number DYNJ56502: UDI/DI 10884389637135 (each) 40884389637136 (case), Lot Number 23BBS491A; 141) Pack Number DYNJ27165T: UDI/DI 10193489945195 (each) 40193489945196 (case), Lot Number 23CBB118A; 142) Pack Number DYNJ27165V: UDI/DI 10888277208872 (each) 40888277208873 (case), Lot Number 23CBN716A; 143) Pack Number DYNJ35449G: UDI/DI 10195327040239 (each) 40195327040230 (case), Lot Number 23CBO497A; 144) Pack Number DYNJ62673A: UDI/DI 10195327026592 (each) 40195327026593 (case), Lot Number 23CDC561A; 145) Pack Number DYNJ37636L: UDI/DI 10195327299064 (each) 40195327299065 (case), Lot Number 23CLA003A; 146) Pack Number DYNJ49604B: UDI/DI 10889942485215 (each) 40889942485216 (case), Lot Number 23CLA052A; 147) Pack Number DYNJ58993C: UDI/DI 10888277764422 (each) 40888277764423 (case), Lot Number 23CLA054A; 148) Pack Number DYNJ37375B: UDI/DI 10193489475920 (each) 40193489475921 (case), Lot Number 23DDA046A; 149) Pack Number DYNJ63202B: UDI/DI 10195327375003 (each) 40195327375004 (case), Lot Number 23DDA346A; 150) Pack Number DYNJ65433: UDI/DI 10193489892734 (each) 40193489892735 (case), Lot Number 23DDA370A; 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• Recalling Firm/ Manufacturer: MEDLINE INDUSTRIES, LP - Northfield; 3 Lakes Dr; Northfield IL 60093-2753
• For Additional Information Contact: Haley Barclay; 866-359-1704
• Manufacturer Reason for Recall: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.
• FDA Determined Cause: Under Investigation by firm
• Action: Medline Industries LP issued a recall notice to its consignees on 02/11/2025 via letter delivered via USPS and email. The notice explained the issue, provided a link to for information pertaining to the risk involved https://www.fda.gov/medical-devices/safety-communications/update-evaluating-plastic-syringes-made-china-potential-device-failures-fda-safety-communication) and request the syringes within the convenience be discarded, except for circumstances where no alternative syringes are readily available. If these syringes must be used, closely monitor for leaks, breakage, and any other problems, and report any quality issues to Medline and the FDA. Distributors were directed to notify their customers.
• Quantity in Commerce: 14589 units
• Distribution: Worldwide distribution - US Nationwide and the country of Canada.
• Total Product Life Cycle: TPLC 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.