Medline Kits: 1) CATH LAB CDS, Model Number: CDS840228F; 2) IR PACK, Model Number: DYNDH2104; 3) CARDIAC CATH PACK-LF, Model Number: DYNJT2164M; 4) ANGIOGRAPHY TRAY, Model Number: DYNJT3078; 5) CATH PACK, Model Number: DYNJT4190; 6) ANGIO VASCULAR PACK, Model Number: DYNJT5717; 7) HEART CATH PACK, Model Number: DYNJ0381139R; 8) CARDIAC CATH PACK, Model Number: DYNJ04529L; 9) CUSTOM RADIOLOGY PACK, Model Number: DYNJ07955L; 10) STVZ CARDIAC CATH PACK, Model Number: DYNJ24619J; 11) CATH TRAY #2, Model Number: DYNJ24706D; 12) CATH LAB PACK, Model Number: DYNJ24802Q; 13) CATH PACK, Model Number: DYNJ30268K; 14) HEART CATHETERIZATION PACK, Model Number: DYNJ30927R; 15) HEART CATH TRAY PACK-LF, Model Number: DYNJ31944D; 16) CATH PACK-LF, Model Number: DYNJ33061D; 17) CATH PACK, Model Number: DYNJ34638K; 18) ANGIOGRAPHY DRAPE PACK, Model Number: DYNJ38120C; 19) CATH PACK, Model Number: DYNJ40904G; 20) CARDIAC CATH-LF, Model Number: DYNJ41057D; 21) CATH LAB PACK, Model Number: DYNJ41172; 22) ANGIOGRAPHY PACK, Model Number: DYNJ42134G; 23) CATH LAB DRAPE PACK, Model Number: DYNJ42455B; 24) ANGIOGRAPHY PACK, Model Number: DYNJ42543B; 25) CATH LAB PACK, Model Number: DYNJ42900D; 26) ANGIOGRAPHY PACK NO SYR, Model Number: DYNJ43009K; 27) CATH PACK (WITH MANIFOLD), Model Number: DYNJ44515L; 28) ANGIO IR DRAPE PACK 319696, Model Number: DYNJ44593I; 29) ANGIOGRAPHY DRAPE PACK, Model Number: DYNJ44850J; 30) CATH LAB PACK, Model Number: DYNJ45296; 31) ANGIO PACK, Model Number: DYNJ50739J; 32) CARDIAC CATH PACK, Model Number: DYNJ51103F; 33) IR ANGIO BODY, Model Number: DYNJ51765D; 34) INTERVENTIONAL TRAY, Model Number: DYNJ52501C; 35) CARDIAC CATH IMF 86040- LF, Model Number: DYNJ53947J; 36) CARDIAC CATH PACK, Model Number: DYNJ54101I; 37) ANGIO KIT, Model Number: DYNJ55686C; 38) CATH LAB PACK, Model Number: DYNJ56141B; 39) ANGIO NEURO PACK, Model Number: DYNJ57685D; 40) CATH PACK, Model Number: DYNJ57729F; 41) CATH PACK, Model Number: DYNJ596

Class II

Recalling firm: Medline Industries, LP
Reason for recall: The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Affected products (lot / model / serial): 1) CDS840228F, UDI-DI: 10889942778546(each), 40889942778547(case), Lot Number: 25ALA420; 2) CDS840228F, UDI-DI: 10889942778546(each), 40889942778547(case), Lot Number: 25CLA774; 3) CDS840228F, UDI-DI: 10889942778546(each), 40889942778547(case), Lot Number: 24LLA038; 4) DYNDH2104, UDI-DI: 10198459273964(each), 40198459273965(case), Lot Number: 25DBR609; 5) DYNJT2164M, UDI-DI: 10198459003165(each), 40198459003166(case), Lot Number: 24JBT885; 6) DYNJT3078, UDI-DI: 10198459305146(each), 40198459305147(case), Lot Number: 25DBN722; 7) DYNJT4190, UDI-DI: 10198459428234(each), 40198459428235(case), Lot Number: 25HBA387; 8) DYNJT5717, UDI-DI: 10198459496684(each), 40198459496685(case), Lot Number: 26ALA778; 9) DYNJ0381139R, UDI-DI: 10198459276019(each), 40198459276010(case), Lot Number: 25JLA029; 10) DYNJ04529L, UDI-DI: 10198459391460(each), 40198459391461(case), Lot Number: 25JLA312; 11) DYNJ07955L, UDI-DI: 10889942628896(each), 40889942628897(case), Lot Number: 24HBM316; 12) DYNJ07955L, UDI-DI: 10889942628896(each), 40889942628897(case), Lot Number: 23HBX895; 13) DYNJ24619J, UDI-DI: 10195327295639(each), 40195327295630(case), Lot Number: 23DBP876; 14) DYNJ24619J, UDI-DI: 10195327295639(each), 40195327295630(case), Lot Number: 23FBG933; 15) DYNJ24619J, UDI-DI: 10195327295639(each), 40195327295630(case), Lot Number: 24GBE563; 16) DYNJ24619J, UDI-DI: 10195327295639(each), 40195327295630(case), Lot Number: 24HBT787; 17) DYNJ24619J, UDI-DI: 10195327295639(each), 40195327295630(case), Lot Number: 24KBC564; 18) DYNJ24619J, UDI-DI: 10195327295639(each), 40195327295630(case), Lot Number: 24LBL445; 19) DYNJ24619J, UDI-DI: 10195327295639(each), 40195327295630(case), Lot Number: 25DBF355; 20) DYNJ24619J, UDI-DI: 10195327295639(each), 40195327295630(case), Lot Number: 25EBG106; 21) DYNJ24706D, UDI-DI: 10889942297122(each), 40889942297123(case), Lot Number: 25BBB510; 22) DYNJ24802Q, UDI-DI: 10198459091476(each), 40198459091477(case), Lot Number: 25DBJ212; 23) DYNJ30268K, UDI-DI: 10198459132636(each), 40198459132637(case), Lot Number: 25EMH059; 24) DYNJ30268K, UDI-DI: 10198459132636(each), 40198459132637(case), Lot Number: 25FMA010; 25) DYNJ30268K, UDI-DI: 10198459132636(each), 40198459132637(case), Lot Number: 25GME803; 26) DYNJ30927R, UDI-DI: 10195327539160(each), 40195327539161(case), Lot Number: 24JME497; 27) DYNJ30927R, UDI-DI: 10195327539160(each), 40195327539161(case), Lot Number: 25AME060; 28) DYNJ30927R, UDI-DI: 10195327539160(each), 40195327539161(case), Lot Number: 25CMA483; 29) DYNJ30927R, UDI-DI: 10195327539160(each), 40195327539161(case), Lot Number: 25CMI507; 30) DYNJ30927R, UDI-DI: 10195327539160(each), 40195327539161(case), Lot Number: 25DMB230; 31) DYNJ30927R, UDI-DI: 10195327539160(each), 40195327539161(case), Lot Number: 25DMF455; 32) DYNJ30927R, UDI-DI: 10195327539160(each), 40195327539161(case), Lot Number: 25EMB900; 33) DYNJ30927R, UDI-DI: 10195327539160(each), 40195327539161(case), Lot Number: 25EMI646; 34) DYNJ31944D, UDI-DI: 10193489440171(each), 40193489440172(case), Lot Number: 23JBA288; 35) DYNJ31944D, UDI-DI: 10193489440171(each), 40193489440172(case), Lot Number: 23JBB352; 36) DYNJ31944D, UDI-DI: 10193489440171(each), 40193489440172(case), Lot Number: 23LBC983; 37) DYNJ31944D, UDI-DI: 10193489440171(each), 40193489440172(case), Lot Number: 24ABR897; 38) DYNJ31944D, UDI-DI: 10193489440171(each), 40193489440172(case), Lot Number: 24EBQ350; 39) DYNJ31944D, UDI-DI: 10193489440171(each), 40193489440172(case), Lot Number: 24FBM413; 40) DYNJ31944D, UDI-DI: 10193489440171(each), 40193489440172(case), Lot Number: 24GBA097; 41) DYNJ31944D, UDI-DI: 10193489440171(each), 40193489440172(case), Lot Number: 24HBU538; 42) DYNJ31944D, UDI-DI: 10193489440171(each), 40193489440172(case), Lot Number: 24IBM289; 43) DYNJ31944D, UDI-DI: 10193489440171(each), 40193489440172(case), Lot Number: 24JBJ568; 44) DYNJ31944D, UDI-DI: 10193489440171(each), 40193489440172(case), Lot Number: 24LBL092; 45) DYNJ31944D, UDI-DI: 10193489440171(each), 40193
Units affected: 160883 units
Distribution pattern: US Nationwide distribution.
Firm location: Northfield, IL, United States
Recall type: Voluntary: Firm initiated
How the firm notified customers: Letter
Product type: Devices
Status: Ongoing
Recall number: Z-1835-2026
Recall initiated: February 25, 2026
FDA classification date: April 17, 2026
FDA report date: April 29, 2026
FDA event ID: 98599
Last updated on HTM Vibe: July 24, 2026

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