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FDAFDA recall Z-0170-2027 · Oct 21, 2026

Medline Industries, LP: Medline surgical convenience kits labeled as: 1) OPEN HEART CDS recall

Recall found

Product

Medline surgical convenience kits labeled as: 1) OPEN HEART CDS, Medline product number/SKU CDS840094R; 2) OPEN HEART CDS, Medline product number/SKU CDS840171AG; 3) MHC AV FISTULA, Medline product number/SKU DYNJ903705K; 4) PERIPHERAL VASC MAJR-LF, Medline product number/SKU CDS840379O; 5) MINOR VASCULAR PACK-LF, Medline product number/SKU DYNJ0349727D; 6) SJHC VASCULAR PK-LF, Medline product number/SKU DYNJ19906L; 7) CABG PACK-LF, Medline product number/SKU DYNJ0824648K; 8) PERIPHERAL VASC MNR-LF, Medline product number/SKU DYNJ22721N; 9) HEART A PACK, Medline product number/SKU DYNJ0362405S; 10) OPEN HEART, Medline product number/SKU DYNJ907676I; 11) FEM POP MARYVIEW, Medline product number/SKU DYNJ911714; 12) CABG PACK, Medline product number/SKU DYNJ906346G; 13) DEBOER HEART MAIN, Medline product number/SKU DYNJ907914I; 14) OPEN HEART A & B PACK, Medline product number/SKU DYNJ9718008AU; 15) OPEN HEART, Medline product number/SKU DYNJ911483A; 16) CABG ACCESSORY PACK, Medline product number/SKU DYNJ59265; 17) HEART, Medline product number/SKU DYNJ908779B; 18) CARDIOVASCULAR PACK, Medline product number/SKU DYNJ69507F; 19) OFF PUMP CABG CDS, Medline product number/SKU CDS840087AN; 20) PACK CABG CHRG, Medline product number/SKU DYNJ905683D; 21) HEART CDS, Medline product number/SKU CDS840179N;

Reason for recall

Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.

What to do

FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.

Recall details

FDA classification
Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Status
Ongoing
Codes, lots and dates
Medline product kit number/SKU CDS840076AD, UDI/DI 10198459311536 (each) 40198459311537 (case), Lot Number 26HBD144; Medline product kit number/SKU CDS840393P, UDI/DI 10198459405266 (each) 40198459405267 (case), Lot Number 26FMA487; Medline product kit number/SKU CDS840132RFP, UDI/DI 10195327669324 (each) 40195327669325 (case), Lot Number 26FBR713; Medline product kit number/SKU DYNJ906775G, UDI/DI 10198459506390 (each) 40198459506391 (case), Lot Number 26DMK788; Medline product kit number/SKU DYNJ906775G, UDI/DI 10198459506390 (each) 40198459506391 (case), Lot Number 26DMG190; Medline product kit number/SKU CDS840393P, UDI/DI 10198459405266 (each) 40198459405267 (case), Lot Number 26DMA855; Medline product kit number/SKU DYNJ902765G, UDI/DI 10198459161599 (each) 40198459161590 (case), Lot Number 26DBO919; Medline product kit number/SKU DYNJ907552B, UDI/DI 10195327260750 (each) 40195327260751 (case), Lot Number 26CML345; Medline product kit number/SKU CDS840393P, UDI/DI 10198459405266 (each) 40198459405267 (case), Lot Number 26CML246; Medline product kit number/SKU CDS840393P, UDI/DI 10198459405266 (each) 40198459405267 (case), Lot Number 26CMH715; Medline product kit number/SKU DYNJ22721N, UDI/DI 10198459229176 (each) 40198459229177 (case), Lot Number 26CMH546; Medline product kit number/SKU CDS840171AG, UDI/DI 10198459640957 (each) 40198459640958 (case), Lot Number 26CMG918; Medline product kit number/SKU DYNJ36240P, UDI/DI 10198459728716 (each) 40198459728717 (case), Lot Number 26CMG812; Medline product kit number/SKU DYNJ45122C, UDI/DI 10193489496369 (each) 40193489496360 (case), Lot Number 26CMG766; Medline product kit number/SKU DYNJ903705K, UDI/DI 10195327615604 (each) 40195327615605 (case), Lot Number 26CMB724; Medline product kit number/SKU CDS981248M, UDI/DI 10198459117336 (each) 40198459117337 (case), Lot Number 26CMA585; Medline product kit number/SKU DYNJ911483A, UDI/DI 10198459515095 (each) 40198459515096 (case), Lot Number 26CLB089; Medline product kit number/SKU CDS985355I, UDI/DI 10198459288081 (each) 40198459288082 (case), Lot Number 26CDA736; Medline product kit number/SKU DYNJ908168I, UDI/DI 10198459433085 (each) 40198459433086 (case), Lot Number 26CBQ271; Medline product kit number/SKU DYNJ902898I, UDI/DI 10198459497230 (each) 40198459497231 (case), Lot Number 26CBN774; Medline product kit number/SKU DYNJ911488A, UDI/DI 10198459666933 (each) 40198459666934 (case), Lot Number 26CBN470; Medline product kit number/SKU DYNJ900523B, UDI/DI 10195327628703 (each) 40195327628704 (case), Lot Number 26CBL270; Medline product kit number/SKU DYNJ911488A, UDI/DI 10198459666933 (each) 40198459666934 (case), Lot Number 26CBK492; Medline product kit number/SKU DYNJ911274C, UDI/DI 10198459594908 (each) 40198459594909 (case), Lot Number 26CBK471; Medline product kit number/SKU CDS840094R, UDI/DI 10198459248122 (each) 40198459248123 (case), Lot Number 26CBA720; Medline product kit number/SKU CDS840171AG, UDI/DI 10198459640957 (each) 40198459640958 (case), Lot Number 26BMK455; Medline product kit number/SKU DYNJ903705K, UDI/DI 10195327615604 (each) 40195327615605 (case), Lot Number 26BMJ864; Medline product kit number/SKU CDS840171AG, UDI/DI 10198459640957 (each) 40198459640958 (case), Lot Number 26BMI610; Medline product kit number/SKU CDS840171AG, UDI/DI 10198459640957 (each) 40198459640958 (case), Lot Number 26BMI603; Medline product kit number/SKU CDS840379O, UDI/DI 10198459229169 (each) 40198459229160 (case), Lot Number 26BMH466; Medline product kit number/SKU DYNJ0349727D, UDI/DI 10195327000158 (each) 40195327000159 (case), Lot Number 26BMD752; Medline product kit number/SKU DYNJ19906L, UDI/DI 10198459180873 (each) 40198459180874 (case), Lot Number 26BMC966; Medline product kit number/SKU DYNJ0824648K, UDI/DI 10193489730371 (each) 40193489730372 (case), Lot Number 26BMC734; Medline product kit number/SKU DYNJ22721N, UDI/DI 10198459229176 (each) 40198459229177 (case), Lot Number 26BMA364; Medline product kit number/SKU DYNJ0362405S, UDI/DI 10198459567223 (each) 40198459567224 (case), Lot Number 26BMA170; Medline product kit number/SKU DYNJ907676I, UDI/DI 10198459207495 (each) 40198459207496 (case), Lot Number 26BMA138; Medline product kit number/SKU DYNJ911714, UDI/DI 10198459515699 (each) 40198459515690 (case), Lot Number 26BLA940; Medline product kit number/SKU DYNJ906346G, UDI/DI 10198459634581 (each) 40198459634582 (case), Lot Number 26BLA926; Medline product kit number/SKU DYNJ907914I, UDI/DI 10198459632310 (each) 40198459632311 (case), Lot Number 26BLA925; Medline product kit number/SKU DYNJ907914I, UDI/DI 10198459632310 (each) 40198459632311 (case), Lot Number 26BLA663; Medline product kit number/SKU DYNJ9718008AU, UDI/DI 10198459291579 (each) 40198459291570 (case), Lot Number 26BLA613; Medline product kit number/SKU DYNJ907914I, UDI/DI 10198459632310 (each) 40198459632311 (case), Lot Number 26BLA573; Medline product kit number/SKU DYNJ906346G, UDI/DI 10198459634581 (each) 40198459634582 (case), Lot Number 26BLA565; Medline product kit number/SKU DYNJ911483A, UDI/DI 10198459515095 (each) 40198459515096 (case), Lot Number 26BLA470; Medline product kit number/SKU DYNJ59265, UDI/DI 10888277771475 (each) 40888277771476 (case), Lot Number 26BLA373; Medline product kit number/SKU DYNJ908779B, UDI/DI 10198459115523 (each) 40198459115524 (case), Lot Number 26BLA298; Medline product kit number/SKU DYNJ911483A, UDI/DI 10198459515095 (each) 40198459515096 (case), Lot Number 26BLA258; Medline product kit number/SKU DYNJ908779B, UDI/DI 10198459115523 (each) 40198459115524 (case), Lot Number 26BLA247; Medline product kit number/SKU DYNJ69507F, UDI/DI 10198459657054 (each) 40198459657055 (case), Lot Number 26BLA226; Medline product kit number/SKU CDS840087AN, UDI/DI 10198459525865 (each) 40198459525866 (case), Lot Number 26BLA144; Medline product kit number/SKU DYNJ905683D, UDI/DI 10198459177996 (each) 40198459177997 (case), Lot Number 26BDA663; Medline product kit number/SKU CDS840179N, UDI/DI 10198459569920 (each) 40198459569921 (case), Lot Number 26BBR932; Medline product kit number/SKU CDS981161AK, UDI/DI 10198459639692 (each) 40198459639693 (case), Lot Number 26BBR892; Medline product kit number/SKU DYNJ911019A, UDI/DI 10198459511882 (each) 40198459511883 (case), Lot Number 26BBP181; Medline product kit number/SKU DYNJ911274C, UDI/DI 10198459594908 (each) 40198459594909 (case), Lot Number 26BBP121; Medline product kit number/SKU DYNJ909083A, UDI/DI 10198459094095 (each) 40198459094096 (case), Lot Number 26BBP119; Medline product kit number/SKU DYNJ908168I, UDI/DI 10198459433085 (each) 40198459433086 (case), Lot Number 26BBO420; Medline product kit number/SKU DYNJ900523B, UDI/DI 10195327628703 (each) 40195327628704 (case), Lot Number 26BBN770; Medline product kit number/SKU DYNJ87026A, UDI/DI 10198459433191 (each) 40198459433192 (case), Lot Number 26BBL891; Medline product kit number/SKU CDS983147L, UDI/DI 10198459023880 (each) 40198459023881 (case), Lot Number 26BBL887; Medline product kit number/SKU DYNJ906945D, UDI/DI 10198459132483 (each) 40198459132484 (case), Lot Number 26BBL761; Medline product kit number/SKU CDS983663K, UDI/DI 10193489952391 (each) 40193489952392 (case), Lot Number 26BBK936; Medline product kit number/SKU CDS840023V, UDI/DI 10198459196812 (each) 40198459196813 (case), Lot Number 26BBI482; Medline product kit number/SKU DYNJ902898I, UDI/DI 10198459497230 (each) 40198459497231 (case), Lot Number 26BBH764; Medline product kit number/SKU DYNJ911019A, UDI/DI 10198459511882 (each) 40198459511883 (case), Lot Number 26BBF471; Medline product kit number/SKU DYNJ85516A, UDI/DI 10198459018862 (each) 40198459018863 (case), Lot Number 26BBF159; Medline product kit number/SKU CDS983139C, UDI/DI 10195327147532 (each) 40195327147533 (case), Lot Number 26BBD975; Medline product kit number/SKU DYNJ902772G, UDI/DI 10198459161605 (each) 40198459161606 (case), Lot Number 26BBD731; Medline product kit number/SKU DYNJ58861B, UDI/DI 10198459346224 (each) 40198459346225 (case), Lot Number 26BBD422; Medline product kit number/SKU CDS984368B, UDI/DI 10198459363641 (each) 40198459363642 (case), Lot Number 26BBD059; Medline product kit number/SKU DYNJ36735F, UDI/DI 10198459081200 (each) 40198459081201 (case), Lot Number 26BBB890; Medline product kit number/SKU DYNJ17299D, UDI/DI 10888277087057 (each) 40888277087058 (case), Lot Number 26BBB301; Medline product kit number/SKU CDS983136I, UDI/DI 10198459079085 (each) 40198459079086 (case), Lot Number 26BBA159; Medline product kit number/SKU DYNJ0362405S, UDI/DI 10198459567223 (each) 40198459567224 (case), Lot Number 26AMK786; Medline product kit number/SKU CDS981248M, UDI/DI 10198459117336 (each) 40198459117337 (case), Lot Number 26AMJ779; Medline product kit number/SKU DYNJ45122C, UDI/DI 10193489496369 (each) 40193489496360 (case), Lot Number 26AMI538; Medline product kit number/SKU DYNJ65781C, UDI/DI 10195327571764 (each) 40195327571765 (case), Lot Number 26AMG486; Medline product kit number/SKU DYNJ65706A, UDI/DI 10198459444357 (each) 40198459444358 (case), Lot Number 26AMF793; Medline product kit number/SKU DYNJ907676I, UDI/DI 10198459207495 (each) 40198459207496 (case), Lot Number 26AMF352; Medline product kit number/SKU DYNJ903705K, UDI/DI 10195327615604 (each) 40195327615605 (case), Lot Number 26AME605; Medline product kit number/SKU DYNJ903705K, UDI/DI 10195327615604 (each) 40195327615605 (case), Lot Number 26AME578; Medline product kit number/SKU DYNJ22052J, UDI/DI 10195327421434 (each) 40195327421435 (case), Lot Number 26AME399; Medline product kit number/SKU DYNJ39488L, UDI/DI 10198459400421 (each) 40198459400422 (case), Lot Number 26AMB258; Medline product kit number/SKU DYNJ0349727D, UDI/DI 10195327000158 (each) 40195327000159 (case), Lot Number 26AMB057; Medline product kit number/SKU DYNJ19906L, UDI/DI 10198459180873 (each) 40198459180874 (case), Lot Number 26AMA702; Medline product kit number/SKU DYNJ911832, UDI/DI 10198459549632 (each) 40198459549633 (case), Lot Number 26AMA153; Medline product kit number/SKU DYNJC9258K, UDI/DI 10198459642524 (each) 40198459642525 (case), Lot Number 26ALA839; Medline product kit number/SKU DYNJ9718008AU, UDI/DI 10198459291579 (each) 40198459291570 (case), Lot Number 26ALA729; Medline product kit number/SKU DYNJ907914G, UDI/DI 10198459312359 (each) 40198459312350 (case), Lot Number 26ALA422; Medline product kit number/SKU DYNJ69507F, UDI/DI 10198459657054 (each) 40198459657055 (case), Lot Number 26ALA285; Medline product kit number/SKU DYNJ911714, UDI/DI 10198459515699 (each) 40198459515690 (case), Lot Number 26ALA206; Medline product kit number/SKU DYNJ910311A, UDI/DI 10198459629143 (each) 40198459629144 (case), Lot Number 26ALA200; Medline product kit number/SKU DYNJ69507D, UDI/DI 10198459556371 (each) 40198459556372 (case), Lot Number 26ALA155; Medline product kit number/SKU CDS983139C, UDI/DI 10195327147532 (each) 40195327147533 (case), Lot Number 26ABX020; Medline product kit number/SKU DYNJ902898I, UDI/DI 10198459497230 (each) 40198459497231 (case), Lot Number 26ABX010; Medline product kit number/SKU CDS983663K, UDI/DI 10193489952391 (each) 40193489952392 (case), Lot Number 26ABW531; Medline product kit number/SKU DYNJT3100, UDI/DI 10198459306907 (each) 40198459306908 (case), Lot Number 26ABW312; Medline product kit number/SKU DYNJ909986F, UDI/DI 10198459626845 (each) 40198459626846 (case), Lot Number 26ABW268; Medline product kit number/SKU CDS840023V, UDI/DI 10198459196812 (each) 40198459196813 (case), Lot Number 26ABV540; Medline product kit number/SKU CDS982752K, UDI/DI 10198459521942 (each) 40198459521943 (case), Lot Number 26ABU956; Medline product kit number/SKU DYNJ86276B, UDI/DI 10198459625770 (each) 40198459625771 (case), Lot Number 26ABU212; Medline product kit number/SKU CDS840396AB, UDI/DI 10198459468742 (each) 40198459468743 (case), Lot Number 26ABT718; Medline product kit number/SKU CDS985384C, UDI/DI 10889942962181 (each) 40889942962182 (case), Lot Number 26ABS989; Medline product kit number/SKU DYNJ41485, UDI/DI 10884389909584 (each) 40884389909585 (case), Lot Number 26ABS676; Medline product kit number/SKU DYNJ66030A, UDI/DI 10193489482355 (each) 40193489482356 (case), Lot Number 26ABS517; Medline product kit number/SKU CDS982411O, UDI/DI 10198459287589 (each) 40198459287580 (case), Lot Number 26ABQ954; Medline product kit number/SKU DYNJ911832, UDI/DI 10198459549632 (each) 40198459549633 (case), Lot Number 26ABQ571; Medline product kit number/SKU DYNJ87026A, UDI/DI 10198459433191 (each) 40198459433192 (case), Lot Number 26ABQ556; Medline product kit number/SKU DYNJ63182I, UDI/DI 10198459485800 (each) 40198459485801 (case), Lot Number 26ABQ280; Medline product kit number/SKU DYNJ41485, UDI/DI 10884389909584 (each) 40884389909585 (case), Lot Number 26ABQ134; Medline product kit number/SKU DYNJ85516A, UDI/DI 10198459018862 (each) 40198459018863 (case), Lot Number 26ABP728; Medline product kit number/SKU CDS840094R, UDI/DI 10198459248122 (each) 40198459248123 (case), Lot Number 26ABP565; Medline product kit number/SKU CDS840459T, UDI/DI 10198459488832 (each) 40198459488833 (case), Lot Number 26ABO346; Medline product kit number/SKU CDS840459T, UDI/DI 10198459488832 (each) 40198459488833 (case), Lot Number 26ABO254; Medline product kit number/SKU DYNJ45170M, UDI/DI 10198459156496 (each) 40198459156497 (case), Lot Number 26ABM156; Medline product kit number/SKU DYNJ56513D, UDI/DI 10195327598921 (each) 40195327598922 (case), Lot Number 26ABL677; Medline product kit number/SKU DYNJ905240L, UDI/DI 10198459520525 (each) 40198459520526 (case), Lot Number 26ABK966; Medline product kit number/SKU DYNJ80567D, UDI/DI 10198459623707 (each) 40198459623708 (case), Lot Number 26ABK527; Medline product kit number/SKU CDS840094R, UDI/DI 10198459248122 (each) 40198459248123 (case), Lot Number 26ABJ572; Medline product kit number/SKU DYNJ68389B, UDI/DI 10195327032722 (each) 40195327032723 (case), Lot Number 26ABJ006; Medline product kit number/SKU CDS983663K, UDI/DI 10193489952391 (each) 40193489952392 (case), Lot Number 26ABH107; Medline product kit number/SKU DYNJ49516A, UDI/DI 10195327398361 (each) 40195327398362 (case), Lot Number 26ABG491; Medline product kit number/SKU DYNJ909833C, UDI/DI 10198459598197 (each) 40198459598198 (case), Lot Number 26ABG192; Medline product kit number/SKU DYNJ908168I, UDI/DI 10198459433085 (each) 40198459433086 (case), Lot Number 26ABF728; Medline product kit number/SKU CDS840451O, UDI/DI 10198459542817 (each) 40198459542818 (case), Lot Number 26ABF504; Medline product kit number/SKU DYNJ55476J, UDI/DI 10198459600043 (each) 40198459600044 (case), Lot Number 26ABE372; Medline product kit number/SKU CDS840094R, UDI/DI 10198459248122 (each) 40198459248123 (case), Lot Number 26ABE139; Medline product kit number/SKU DYNJ58124D, UDI/DI 10198459524615 (each) 40198459524616 (case), Lot Number 26ABE028; Medline product kit number/SKU CDS840396AB, UDI/DI 10198459468742 (each) 40198459468743 (case), Lot Number 26ABD873; Medline product kit number/SKU CDS982411O, UDI/DI 10198459287589 (each) 40198459287580 (case), Lot Number 26ABD721; Medline product kit number/SKU DYNJ905862I, UDI/DI 10198459196034 (each) 40198459196035 (case), Lot Number 26ABC255; Medline product kit number/SKU DYNJ904790M, UDI/DI 10198459411298 (each) 40198459411299 (case), Lot Number 26ABB900; Medline product kit number/SKU DYNJ906775G, UDI/DI 10198459506390 (each) 40198459506391 (case), Lot Number 25LMJ089; Medline product kit number/SKU DYNJ33387N, UDI/DI 10198459376788 (each) 40198459376789 (case), Lot Number 25LMI963; Medline product kit number/SKU DYNJ906775G, UDI/DI 10198459506390 (each) 40198459506391 (case), Lot Number 25LMI951; Medline product kit number/SKU DYNJ911832, UDI/DI 10198459549632 (each) 40198459549633 (case), Lot Number 25LMH103; Medline product kit number/SKU DYNJ907552B, UDI/DI 10195327260750 (each) 40195327260751 (case), Lot Number 25LMG711; Medline product kit number/SKU CDS840171AF, UDI/DI 10198459202858 (each) 40198459202859 (case), Lot Number 25LME940; Medline product kit number/SKU DYNJ63100I, UDI/DI 10198459351570 (each) 40198459351571 (case), Lot Number 25LME852; Medline product kit number/SKU DYNJ22721N, UDI/DI 10198459229176 (each) 40198459229177 (case), Lot Number 25LME780; Medline product kit number/SKU DYNJ903705K, UDI/DI 10195327615604 (each) 40195327615605 (case), Lot Number 25LME588; Medline product kit number/SKU DYNJ40638B, UDI/DI 10195327107833 (each) 40195327107834 (case), Lot Number 25LME087; Medline product kit number/SKU DYNJ20488S, UDI/DI 10198459249198 (each) 40198459249199 (case), Lot Number 25LMC659; Medline product kit number/SKU CDS840171AF, UDI/DI 10198459202858 (each) 40198459202859 (case), Lot Number 25LMC106; Medline product kit number/SKU DYNJ0518572I, UDI/DI 10195327330828 (each) 40195327330829 (case), Lot Number 25LMA585; Medline product kit number/SKU CDS840231U, UDI/DI 10198459101724 (each) 40198459101725 (case), Lot Number 25LLA901; Medline product kit number/SKU DYNJ21971AD, UDI/DI 10195327227050 (each) 40195327227051 (case), Lot Number 25LDB956; Medline product kit number/SKU DYNJ39525A, UDI/DI 10198459363696 (each) 40198459363697 (case), Lot Number 25LBU560; Medline product kit number/SKU CDS981161AJ, UDI/DI 10198459055348 (each) 40198459055349 (case), Lot Number 25LBU496; Medline product kit number/SKU DYNJ67929F, UDI/DI 10195327519490 (each) 40195327519491 (case), Lot Number 25LBT851; Medline product kit number/SKU DYNJ55476J, UDI/DI 10198459600043 (each) 40198459600044 (case), Lot Number 25LBT622; Medline product kit number/SKU DYNJ909083A, UDI/DI 10198459094095 (each) 40198459094096 (case), Lot Number 25LBT080; Medline product kit number/SKU CDS840023V, UDI/DI 10198459196812 (each) 40198459196813 (case), Lot Number 25LBT061; Medline product kit number/SKU DYNJ58124D, UDI/DI 10198459524615 (each) 40198459524616 (case), Lot Number 25LBS638; Medline product kit number/SKU CDS840132RFP, UDI/DI 10195327669324 (each) 40195327669325 (case), Lot Number 25LBR140; Medline product kit number/SKU DYNJ905240L, UDI/DI 10198459520525 (each) 40198459520526 (case), Lot Number 25LBO989; Medline product kit number/SKU DYNJ902765G, UDI/DI 10198459161599 (each) 40198459161590 (case), Lot Number 25LBO909; Medline product kit number/SKU DYNJ42156, UDI/DI 10884389913956 (each) 40884389913957 (case), Lot Number 25LBO358; Medline product kit number/SKU DYNJ906018G, UDI/DI 10198459526732 (each) 40198459526733 (case), Lot Number 25LBN994; Medline product kit number/SKU DYNJ80567D, UDI/DI 10198459623707 (each) 40198459623708 (case), Lot Number 25LBN849; Medline product kit number/SKU DYNJ909083A, UDI/DI 10198459094095 (each) 40198459094096 (case), Lot Number 25LBN783; Medline product kit number/SKU DYNJ67151G, UDI/DI 10198459424458 (each) 40198459424459 (case), Lot Number 25LBN688; Medline product kit number/SKU DYNJ45170M, UDI/DI 10198459156496 (each) 40198459156497 (case), Lot Number 25LBM763; Medline product kit number/SKU SYNJ10251G, UDI/DI 10195327358198 (each) 40195327358199 (case), Lot Number 25LBM663; Medline product kit number/SKU CDS982412Q, UDI/DI 10198459525858 (each) 40198459525859 (case), Lot Number 25LBM544; Medline product kit number/SKU DYNJ60982A, UDI/DI 10198459037900 (each) 40198459037901 (case), Lot Number 25LBL857; Medline product kit number/SKU DYNJ911019A, UDI/DI 10198459511882 (each) 40198459511883 (case), Lot Number 25LBL747; Medline product kit number/SKU DYNJ58124D, UDI/DI 10198459524615 (each) 40198459524616 (case), Lot Number 25LBK676; Medline product kit number/SKU DYNJ64530B, UDI/DI 10198459402753 (each) 40198459402754 (case), Lot Number 25LBK582; Medline product kit number/SKU DYNJ0373120AF, UDI/DI 10198459338328 (each) 40198459338329 (case), Lot Number 25LBJ587; Medline product kit number/SKU DYNJ911488, UDI/DI 10198459361616 (each) 40198459361617 (case), Lot Number 25LBI881; Medline product kit number/SKU CDS840132RFP, UDI/DI 10195327669324 (each) 40195327669325 (case), Lot Number 25LBI878; Medline product kit number/SKU DYNJ911488, UDI/DI 10198459361616 (each) 40198459361617 (case), Lot Number 25LBH792; Medline product kit number/SKU DYNJ905240L, UDI/DI 10198459520525 (each) 40198459520526 (case), Lot Number 25LBH680; Medline product kit number/SKU CDS983663K, UDI/DI 10193489952391 (each) 40193489952392 (case), Lot Number 25LBG199; Medline product kit number/SKU CDS982411O, UDI/DI 10198459287589 (each) 40198459287580 (case), Lot Number 25LBF932; Medline product kit number/SKU CDS983147L, UDI/DI 10198459023880 (each) 40198459023881 (case), Lot Number 25LBE966; Medline product kit number/SKU DYNJ911589, UDI/DI 10198459419539 (each) 40198459419530 (case), Lot Number 25LBD975; Medline product kit number/SKU DYNJ67929F, UDI/DI 10195327519490 (each) 40195327519491 (case), Lot Number 25LBD706; Medline product kit number/SKU DYNJ86851A, UDI/DI 10198459345944 (each) 40198459345945 (case), Lot Number 25LBB236; Medline product kit number/SKU DYNJ60115C, UDI/DI 10198459194641 (each) 40198459194642 (case), Lot Number 25KMJ469; Medline product kit number/SKU DYNJ0349727D, UDI/DI 10195327000158 (each) 40195327000159 (case), Lot Number 25KMI642; Medline product kit number/SKU CDS840171AF, UDI/DI 10198459202858 (each) 40198459202859 (case), Lot Number 25KMI489; Medline product kit number/SKU DYNJ65781C, UDI/DI 10195327571764 (each) 40195327571765 (case), Lot Number 25KMI270; Medline product kit number/SKU DYNJ54376D, UDI/DI 10198459264856 (each) 40198459264857 (case), Lot Number 25KMF550; Medline product kit number/SKU DYNJ907552B, UDI/DI 10195327260750 (each) 40195327260751 (case), Lot Number 25KME732; Medline product kit number/SKU DYNJ39488L, UDI/DI 10198459400421 (each) 40198459400422 (case), Lot Number 25KMD297; Medline product kit number/SKU DYNJ907676I, UDI/DI 10198459207495 (each) 40198459207496 (case), Lot Number 25KMD135; Medline product kit number/SKU DYNJ65706A, UDI/DI 10198459444357 (each) 40198459444358 (case), Lot Number 25KMC931; Medline product kit number/SKU DYNJ60660F, UDI/DI 10198459574436 (each) 40198459574437 (case), Lot Number 25KMC719; Medline product kit number/SKU DYNJ0362405S, UDI/DI 10198459567223 (each) 40198459567224 (case), Lot Number 25KMC201; Medline product kit number/SKU CDS981248M, UDI/DI 10198459117336 (each) 40198459117337 (case), Lot Number 25KMB731; Medline product kit number/SKU DYNJ63100I, UDI/DI 10198459351570 (each) 40198459351571 (case), Lot Number 25KMB626; Medline product kit number/SKU DYNJ911483A, UDI/DI 10198459515095 (each) 40198459515096 (case), Lot Number 25KLA776; Medline product kit number/SKU DYNJ69507D, UDI/DI 10198459556371 (each) 40198459556372 (case), Lot Number 25KLA557; Medline product kit number/SKU CDS840087AN, UDI/DI 10198459525865 (each) 40198459525866 (case), Lot Number 25KLA435; Medline product kit number/SKU DYNJ911714, UDI/DI 10198459515699 (each) 40198459515690 (case), Lot Number 25KLA271; Medline product kit number/SKU CDS840231U, UDI/DI 10198459101724 (each) 40198459101725 (case), Lot Number 25KLA262; Medline product kit number/SKU DYNJ904678L, UDI/DI 10198459555664 (each) 40198459555665 (case), Lot Number 25KDB804; Medline product kit number/SKU DYNJ21971AD, UDI/DI 10195327227050 (each) 40195327227051 (case), Lot Number 25KDA680; Medline product kit number/SKU DYNJ45170M, UDI/DI 10198459156496 (each) 40198459156497 (case), Lot Number 25KBT603; Medline product kit number/SKU CDS982412Q, UDI/DI 10198459525858 (each) 40198459525859 (case), Lot Number 25KBT275; Medline product kit number/SKU DYNJ85516A, UDI/DI 10198459018862 (each) 40198459018863 (case), Lot Number 25KBS637; Medline product kit number/SKU DYNJ55476J, UDI/DI 10198459600043 (each) 40198459600044 (case), Lot Number 25KBS565; Medline product kit number/SKU DYNJ904790M, UDI/DI 10198459411298 (each) 40198459411299 (case), Lot Number 25KBR831; Medline product kit number/SKU DYNJ900523B, UDI/DI 10195327628703 (each) 40195327628704 (case), Lot Number 25KBR490; Medline product kit number/SKU CDS984368B, UDI/DI 10198459363641 (each) 40198459363642 (case), Lot Number 25KBR078; Medline product kit number/SKU DYNJ80567C, UDI/DI 10198459154379 (each) 40198459154370 (case), Lot Number 25KBQ591; Medline product kit number/SKU DYNJ909833B, UDI/DI 10198459381409 (each) 40198459381400 (case), Lot Number 25KBQ549; Medline product kit number/SKU DYNJ56513D, UDI/DI 10195327598921 (each) 40195327598922 (case), Lot Number 25KBO962; Medline product kit number/SKU DYNJ65714B, UDI/DI 10193489938685 (each) 40193489938686 (case), Lot Number 25KBO642; Medline product kit number/SKU DYNJ63182I, UDI/DI 10198459485800 (each) 40198459485801 (case), Lot Number 25KBO533; Medline product kit number/SKU DYNJ905862I, UDI/DI 10198459196034 (each) 40198459196035 (case), Lot Number 25KBN920; Medline product kit number/SKU DYNJ902554K, UDI/DI 10198459522321 (each) 40198459522322 (case), Lot Number 25KBN826; Medline product kit number/SKU CDS840179N, UDI/DI 10198459569920 (each) 40198459569921 (case), Lot Number 25KBN281; Medline product kit number/SKU DYNJ86276A, UDI/DI 10198459267413 (each) 40198459267414 (case), Lot Number 25KBN210; Medline product kit number/SKU DYNJ60982A, UDI/DI 10198459037900 (each) 40198459037901 (case), Lot Number 25KBL824; Medline product kit number/SKU DYNJ80890F, UDI/DI 10198459358890 (each) 40198459358891 (case), Lot Number 25KBL786; Medline product kit number/SKU DYNJ58861B, UDI/DI 10198459346224 (each) 40198459346225 (case), Lot Number 25KBL650; Medline product kit number/SKU DYNJ68389B, UDI/DI 10195327032722 (each) 40195327032723 (case), Lot Number 25KBL450; Medline product kit number/SKU DYNJT3100, UDI/DI 10198459306907 (each) 40198459306908 (case), Lot Number 25KBK571; Medline product kit number/SKU CDS840179N, UDI/DI 10198459569920 (each) 40198459569921 (case), Lot Number 25KBK441; Medline product kit number/SKU CDS840396AB, UDI/DI 10198459468742 (each) 40198459468743 (case), Lot Number 25KBK109; Medline product kit number/SKU DYNJ39525A, UDI/DI 10198459363696 (each) 40198459363697 (case), Lot Number 25KBJ487; Medline product kit number/SKU DYNJ906945D, UDI/DI 10198459132483 (each) 40198459132484 (case), Lot Number 25KBI793; Medline product kit number/SKU DYNJ902772G, UDI/DI 10198459161605 (each) 40198459161606 (case), Lot Number 25KBI695; Medline product kit number/SKU DYNJ911589, UDI/DI 10198459419539 (each) 40198459419530 (case), Lot Number 25KBI662; Medline product kit number/SKU DYNJ902898I, UDI/DI 10198459497230 (each) 40198459497231 (case), Lot Number 25KBI356; Medline product kit number/SKU DYNJ906951D, UDI/DI 10198459132490 (each) 40198459132491 (case), Lot Number 25KBI315; Medline product kit number/SKU DYNJ911019A, UDI/DI 10198459511882 (each) 40198459511883 (case), Lot Number 25KBH527; Medline product kit number/SKU CDS840459T, UDI/DI 10198459488832 (each) 40198459488833 (case), Lot Number 25KBH193; Medline product kit number/SKU DYNJ911488, UDI/DI 10198459361616 (each) 40198459361617 (case), Lot Number 25KBF034; Medline product kit number/SKU DYNJ67151G, UDI/DI 10198459424458 (each) 40198459424459 (case), Lot Number 25KBD759; Medline product kit number/SKU CDS982752K, UDI/DI 10198459521942 (each) 40198459521943 (case), Lot Number 25KBC947; Medline product kit number/SKU SYNJ10074C, UDI/DI 10193489337877 (each) 40193489337878 (case), Lot Number 25KBA845; Medline product kit number/SKU DYNJ902765G, UDI/DI 10198459161599 (each) 40198459161590 (case), Lot Number 25KBA596; Medline product kit number/SKU DYNJ906945D, UDI/DI 10198459132483 (each) 40198459132484 (case), Lot Number 25KBA544; Medline product kit number/SKU DYNJ906945D, UDI/DI 10198459132483 (each) 40198459132484 (case), Lot Number 25KBA511; Medline product kit number/SKU DYNJ19906L, UDI/DI 10198459180873 (each) 40198459180874 (case), Lot Number 25JMK236; Medline product kit number/SKU DYNJ36052Q, UDI/DI 10198459281570 (each) 40198459281571 (case), Lot Number 25JMJ692; Medline product kit number/SKU DYNJ45122C, UDI/DI 10193489496369 (each) 40193489496360 (case), Lot Number 25JMJ067; Medline product kit number/SKU DYNJ36240O, UDI/DI 10198459370724 (each) 40198459370725 (case), Lot Number 25JMH662; Medline product kit number/SKU DYNJ44647C, UDI/DI 10195327011192 (each) 40195327011193 (case), Lot Number 25JMH207; Medline product kit number/SKU DYNJ22052J, UDI/DI 10195327421434 (each) 40195327421435 (case), Lot Number 25JMH074; Medline product kit number/SKU DYNJ63487J, UDI/DI 10198459433443 (each) 40198459433444 (case), Lot Number 25JMG573; Medline product kit number/SKU DYNJ22721N, UDI/DI 10198459229176 (each) 40198459229177 (case), Lot Number 25JMF968; Medline product kit number/SKU DYNJ22721N, UDI/DI 10198459229176 (each) 40198459229177 (case), Lot Number 25JMF608; Medline product kit number/SKU DYNJ19906L, UDI/DI 10198459180873 (each) 40198459180874 (case), Lot Number 25JMF384; Medline product kit number/SKU DYNJ20488S, UDI/DI 10198459249198 (each) 40198459249199 (case), Lot Number 25JME900; Medline product kit number/SKU DYNJ907676I, UDI/DI 10198459207495 (each) 40198459207496 (case), Lot Number 25JME071; Medline product kit number/SKU DYNJ63075G, UDI/DI 10198459351648 (each) 40198459351649 (case), Lot Number 25JMD197; Medline product kit number/SKU DYNJ0349727D, UDI/DI 10195327000158 (each) 40195327000159 (case), Lot Number 25JMC468; Medline product kit number/SKU DYNJ36052Q, UDI/DI 10198459281570 (each) 40198459281571 (case), Lot Number 25JMC321; Medline product kit number/SKU DYNJ63487J, UDI/DI 10198459433443 (each) 40198459433444 (case), Lot Number 25JMC002; Medline product kit number/SKU DYNJ0362405R, UDI/DI 10195327008437 (each) 40195327008438 (case), Lot Number 25JMB006; Medline product kit number/SKU DYNJ60115C, UDI/DI 10198459194641 (each) 40198459194642 (case), Lot Number 25JMA903; Medline product kit number/SKU DYNJ56796, UDI/DI 10889942681457 (each) 40889942681458 (case), Lot Number 25JMA629; Medline product kit number/SKU DYNJ906346F, UDI/DI 10195327624309 (each) 40195327624300 (case), Lot Number 25JLB110; Medline product kit number/SKU DYNJ910311, UDI/DI 10195327623494 (each) 40195327623495 (case), Lot Number 25JLA880; Medline product kit number/SKU DYNJ68878, UDI/DI 10193489846164 (each) 40193489846165 (case), Lot Number 25JLA565; Medline product kit number/SKU CDS840231U, UDI/DI 10198459101724 (each) 40198459101725 (case), Lot Number 25JLA550; Medline product kit number/SKU DYNJ906346F, UDI/DI 10195327624309 (each) 40195327624300 (case), Lot Number 25JLA547; Medline product kit number/SKU CDS840087AN, UDI/DI 10198459525865 (each) 40198459525866 (case), Lot Number 25JLA498; Medline product kit number/SKU CDS985355I, UDI/DI 10198459288081 (each) 40198459288082 (case), Lot Number 25JDA836; Medline product kit number/SKU DYNJ905683D, UDI/DI 10198459177996 (each) 40198459177997 (case), Lot Number 25JDA585; Medline product kit number/SKU CDS982411O, UDI/DI 10198459287589 (each) 40198459287580 (case), Lot Number 25JBU526; Medline product kit number/SKU CDS840094R, UDI/DI 10198459248122 (each) 40198459248123 (case), Lot Number 25JBU505; Medline product kit number/SKU CDS985384C, UDI/DI 10889942962181 (each) 40889942962182 (case), Lot Number 25JBT360; Medline product kit number/SKU CDS840023V, UDI/DI 10198459196812 (each) 40198459196813 (case), Lot Number 25JBT090; Medline product kit number/SKU DYNJ0373120AF, UDI/DI 10198459338328 (each) 40198459338329 (case), Lot Number 25JBR789; Medline product kit number/SKU DYNJ906951D, UDI/DI 10198459132490 (each) 40198459132491 (case), Lot Number 25JBR478; Medline product kit number/SKU SYNJ10251G, UDI/DI 10195327358198 (each) 40195327358199 (case), Lot Number 25JBR350; Medline product kit number/SKU CDS840396AB, UDI/DI 10198459468742 (each) 40198459468743 (case), Lot Number 25JBQ605; Medline product kit number/SKU CDS840094R, UDI/DI 10198459248122 (each) 40198459248123 (case), Lot Number 25JBP492; Medline product kit number/SKU DYNJ01201L, UDI/DI 10888277744806 (each) 40888277744807 (case), Lot Number 25JBO435; Medline product kit number/SKU DYNJ906018G, UDI/DI 10198459526732 (each) 40198459526733 (case), Lot Number 25JBO279; Medline product kit number/SKU CDS983663K, UDI/DI 10193489952391 (each) 40193489952392 (case), Lot Number 25JBO065; Medline product kit number/SKU DYNJ901240D, UDI/DI 101984595211
Quantity
193374 kits
Distribution
US Nationwide distribution.
Recalling firm
Medline Industries, LP, Northfield, IL
Voluntary or mandated
Voluntary: Firm initiated
Recall started
2026-09-02

Source: openFDA enforcement record Z-0170-2027 · search recall number Z-0170-2027 in FDA's Enforcement Report.

Copied from the agency record without changes. Data as of Oct 26, 2026, 8:14 PM EDT. The agency notice is the final word.

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