Medline Industries, LP — Medline Convenience Kits: 1) TRUNK KIT W/EXPIRATION, Model Number: DYKM1361A; 2) TRUNK KIT 1EA, Model Number: DYKM2013; 3) TRUNK KIT 1EA, Model Number: DYKM2013A; 4) RN
⚠️ Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for sterile products.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- January 5, 2026
Worldwide distribution - US Nationwide and the countries of Bahamas, Bermuda, Cayman Islands.
What's affected?
- Product
- Medline Convenience Kits: 1) TRUNK KIT W/EXPIRATION, Model Number: DYKM1361A; 2) TRUNK KIT 1EA, Model Number: DYKM2013; 3) TRUNK KIT 1EA, Model Number: DYKM2013A; 4) RN TRUNK KIT, Model Number: DYKM2699; 5) TRUNK KIT, Model Number: DYKTRUNK1
- Lot code
- 25JBG340
Additional details
1) DYKM1361A, UDI-DI: 10193489586862(each), 40193489586863(case), Lot Number: 25JBG340; 2) DYKM1361A, UDI-DI: 10193489586862(each), 40193489586863(case), Lot Number: 25EBV829; 3) DYKM1361A, UDI-DI: 10193489586862(each), 40193489586863(case), Lot Number: 25CBM029; 4) DYKM1361A, UDI-DI: 10193489586862(each), 40193489586863(case), Lot Number: 25BBI797; 5) DYKM1361A, UDI-DI: 10193489586862(each), 40193489586863(case), Lot Number: 25ABW687; 6) DYKM2013, UDI-DI: 10193489796582(each), 40193489796583(case), Lot Number: 23EBN045; 7) DYKM2013, UDI-DI: 10193489796582(each), 40193489796583(case), Lot Number: 23DBM064; 8) DYKM2013A, UDI-DI: 10195327419868(each), 40195327419869(case), Lot Number: 25HBB845; 9) DYKM2013A, UDI-DI: 10195327419868(each), 40195327419869(case), Lot Number: 25GBS259; 10) DYKM2013A, UDI-DI: 10195327419868(each), 40195327419869(case), Lot Number: 25DBR145; 11) DYKM2013A, UDI-DI: 10195327419868(each), 40195327419869(case), Lot Number: 25BBS769; 12) DYKM2013A, UDI-DI: 10195327419868(each), 40195327419869(case), Lot Number: 24KBJ466; 13) DYKM2013A, UDI-DI: 10195327419868(each), 40195327419869(case), Lot Number: 24JBQ815; 14) DYKM2013A, UDI-DI: 10195327419868(each), 40195327419869(case), Lot Number: 24IBU526; 15) DYKM2013A, UDI-DI: 10195327419868(each), 40195327419869(case), Lot Number: 23IBJ540; 16) DYKM2013A, UDI-DI: 10195327419868(each), 40195327419869(case), Lot Number: 23HBP844; 17) DYKM2013A, UDI-DI: 10195327419868(each), 40195327419869(case), Lot Number: 23HBE308; 18) DYKM2013A, UDI-DI: 10195327419868(each), 40195327419869(case), Lot Number: 23GBT102; 19) DYKM2699, UDI-DI: 10195327610654(each), 40195327610655(case), Lot Number: 25DLA344; 20) DYKM2699, UDI-DI: 10195327610654(each), 40195327610655(case), Lot Number: 25CLA657; 21) DYKM2699, UDI-DI: 10195327610654(each), 40195327610655(case), Lot Number: 24GLB208; 22) DYKM2699, UDI-DI: 10195327610654(each), 40195327610655(case), Lot Number: 24ELA332; 23) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 25HBS451; 24) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 25HBS450; 25) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 25HBE908; 26) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 25HBE909; 27) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 25GBM037; 28) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 25GBK565; 29) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 25FBL177; 30) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 25EBP727; 31) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 25EBO749; 32) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 25DBQ021; 33) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 25DBD942; 34) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 25DBA345; 35) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 25BBU730; 36) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 25BBS503; 37) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 25ABM247; 38) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 24KBN725; 39) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 24KBE264; 40) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 24IBH956; 41) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 24IBH955; 42) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 24IBH957; 43) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 24HBQ854; 44) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 24HBO200; 45) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 24GBN624; 46) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 24FBH929; 47) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 24FBG790; 48) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 24FBD096; 49) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 24DBS507; 50) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 24DBC075; 51) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 24CBG460; 52) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 24ABO402; 53) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 23LBU172; 54) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 23KBK857; 55) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 23KBJ794; 56) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 23JBM608; 57) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 23IBQ747; 58) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 23IBO843; 59) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 23IBO844; 60) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 23HBT781; 61) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 23FBK991; 62) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 23FBC676; 63) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 23EBG472; 64) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 23CBW700; 65) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 23CBM546; Additional Lot numbers as of 3/27/26: 1) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 25IBL812; 2) DYKTRUNK1, UDI-DI: 10888277572195(each), 40888277572196(case), Lot Number: 25IBH378
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 10550 units (495 additional units 3/27/26).
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