Z-0170-2027 Class II Ongoing

Recalled by Medline Industries, LP — Northfield, IL

FDA device recall Z-0170-2027 was initiated by Medline Industries, LP on Sep 2, 2026 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 193374 kits.

Recall Details

Product Type
Devices
Report Date
Oct 21, 2026
Initiation Date
Sep 2, 2026
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
193374 kits

Product Description

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.

Distribution Pattern

US Nationwide distribution.

Code Information

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

Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-0170-2027
openFDA file date
Oct 26, 2026
Loaded by RegDataLab
Oct 27, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.