Recall archive / FDA device enforcement
Medline procedure kits labeled as: 1) ACL ARTHROSCOPY PACK, Pack Number DYNJ55316G; 2) ARTERIOGRAM PACK, Pack Number ... — FDA record Z-1465-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Feb 11, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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...
- Reason
- 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.
- Classification
- Class II
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 14589 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1465-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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... |
The agency lot list is longer than this excerpt. Read the complete list at the official source.
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide distribution - US Nationwide and the country of Canada.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Apr 2, 2025
- Recall initiation date
- Feb 11, 2025
- Center classification date
- Mar 26, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.