FDAFDA · Food and drugs·Recall number Z-2092-2026
Medline Convenience Kits: 1) ANGIO PROCEDURE PACK, Model Number:00-401824AB; 2) OR ARTERIOGRAM, Model Number:CDS985094F; 3) INTRAVASOR CATH KIT, Model Number:DYK1060193I; 4) KIT SURG ONC LAP DIAG/CV CATH, Model Number:DYKMBNDL153; 5) KIT ACES INSERT PERCUTANEOUS T, Model Number:DYKMBNDL4A; 6) KIT ACES INSERT PERCUTANEOUS T, Model Number:DYKMBNDL4B; 7) VEIN PROCEDURE KIT, Model Number:DYNDA2076C; 8) CARDIAC CATH PACK-LF, Model Number:DYNJ0150605AC; 9) CARDIAC CATH PACK-LF, Model Number:DYNJ0368386D; 10) CATH LAB PACK-LF, Model Number:DYNJ0648473Y; 11) NBMC CATH PACK-LF, Model Number:DYNJ0803367I; 12) RADIOLOGY PACK-LF, Model Number:DYNJ0928124C; 13) ANGIO PACK-LF, Model Number:DYNJ0954970I; 14) SPECIALS TRAY RADIOLOGY, Model Number:DYNJ16803D; 15) CARDIAC CATH PACK, Model Number:DYNJ19946M; 16) CATH LAB PACK, Model Number:DYNJ30955I; 17) CATH LAB PACK, Model Number:DYNJ31773K; 18) CATH PACK-LF, Model Number:DYNJ33061D; 19) DB CCL OAKWOOD PACK-LF, Model Number:DYNJ33620D; 20) CARDIAC CATH PACK MRH-LF, Model Number:DYNJ35300M; 21) CATH LAB PK, Model Number:DYNJ35643C; 22) CARDIAC CATH PACK-LF, Model Number:DYNJ39066B; 23) ANGIOGRAPHY PACK, Model Number:DYNJ42134G; 24) CATH PACK-LF, Model Number:DYNJ43101C; 25) OR ANGIO PACK-LF, Model Number:DYNJ43415D; 26) OR ANGIO PACK-LF, Model Number:DYNJ43415F; 27) ANGIOPLASTY PACK, Model Number:DYNJ44700J; 28) ANGIOGRAPHY DRAPE PACK, Model Number:DYNJ44850J; 29) RADIOLOGICAL PACK, Model Number:DYNJ44889O; 30) CARDIAC CATH PACK, Model Number:DYNJ47370B; 31) ANGIOGRAPHY PACK, Model Number:DYNJ53129D; 32) ANGIOGRAPHY DRAPE PACK, Model Number:DYNJ56772G; 33) DR. MOHINDRA PACK, Model Number:DYNJ57602G; 34) NE ENDO VASCULAR PACK, Model Number:DYNJ57940B; 35) CARDIAC CATH PACK - Q1, Model Number:DYNJ58048C; 36) OR ANGIO, Model Number:DYNJ59931B; 37) LPCH PERRY CATH PACK, Model Number:DYNJ67378C; 38) HOSPITAL REGIONAL DE CONCEPCIO, Model Number:DYNJ67918A; 39) CATH LAB PACK, Model Number:DYNJ68633; 40) STEWARD CATH LAB PACK GSS, Model Number:DYNJ81197B; 41) STEWARD CATH LAB PACK GSS, Model Number:DYNJ81197C; 42) STEWARD CATH LAB PACK GSS, Model Number:DYNJ81197D; 43) STEWARD CATH LAB PACK GSS, Model Number:DYNJ81197F; 44) STEWARD CATH LAB PACK GSS, Model Number:DYNJ81197G; 45) STEWARD CATH LAB PACK GSS, Model Number:DYNJ81197I; 46) BASIC CARDIAC CATH PACK, Model Number:DYNJ81593B; 47) CATH LAB PACK, Model Number:DYNJ83073; 48) UMC EL PASO CATH PACK, Model Number:DYNJ83089; 49) DR. MOHINDRA PACK, Model Number:DYNJ83819A; 50) VZ VAS/ANG PACK, Model Number:DYNJ83981; 51) WCPN CARDIOLOGY PACK, Model Number:DYNJ84539; 52) CATH LAB, Model Number:DYNJ85511; 53) CATH LAB, Model Number:DYNJ85511A; 54) ANGIOGRAPHY DRAPE PACK, Model Number:DYNJT1520K; 55) CVC BUNDLE KIT, Model Number:ECVC6225A; 56) CVC 3L 7F 20CM VANTEX, Model Number:ECVC7265A; 57) ANGIOGRAPHY TRAY, Model Number:MNS9130
Published May 13, 2026 · Recall initiated: January 7, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Medline Industries, LP
- Distributor
- Worldwide - US Nationwide distribution.
- Lot
- 1) 00-401824AB, UDI-DI: 10198459089169(each), 40198459089160(case), Lot Number: 24IBQ637; 2) 00-401824AB, UDI-DI: 10198459089169(each), 40198459089160(case), Lot Number: 24KBF279; 3) 00-401824AB, UDI-DI: 10198459089169(each), 40198459089160(case), Lot Number: 24LBF132; 4) 00-401824AB, UDI-DI: 10198459089169(each), 40198459089160(case), Lot Number: 25CBJ807; 5) 00-401824AB, UDI-DI: 10198459089169(each), 40198459089160(case), Lot Number: 25DBO471; 6) 00-401824AB, UDI-DI: 10198459089169(each), 40198459089160(case), Lot Number: 25GBK506; 7) CDS985094F, UDI-DI: 10195327657642(each), 40195327657643(case), Lot Number: 25AMG933; 8) DYK1060193I, UDI-DI: 10884389871737(each), 40884389871738(case), Lot Number: 22KBQ113; 9) DYK1060193I, UDI-DI: 10884389871737(each), 40884389871738(case), Lot Number: 23ABU376; 10) DYK1060193I, UDI-DI: 10884389871737(each), 40884389871738(case), Lot Number: 23DBD193; 11) DYK1060193I, UDI-DI: 10884389871737(each), 40884389871738(case), Lot Number: 23GBT819; 12) DYK1060193I, UDI-DI: 10884389871737(each), 40884389871738(case), Lot Number: 23HBQ238; 13) DYK1060193I, UDI-DI: 10884389871737(each), 40884389871738(case), Lot Number: 23IBR569; 14) DYK1060193I, UDI-DI: 10884389871737(each), 40884389871738(case), Lot Number: 23KBH770; 15) DYK1060193I, UDI-DI: 10884389871737(each), 40884389871738(case), Lot Number: 23LBO849; 16) DYK1060193I, UDI-DI: 10884389871737(each), 40884389871738(case), Lot Number: 24ABW181; 17) DYK1060193I, UDI-DI: 10884389871737(each), 40884389871738(case), Lot Number: 24EBM208; 18) DYK1060193I, UDI-DI: 10884389871737(each), 40884389871738(case), Lot Number: 24GBA239; 19) DYK1060193I, UDI-DI: 10884389871737(each), 40884389871738(case), Lot Number: 24IBE619; 20) DYK1060193I, UDI-DI: 10884389871737(each), 40884389871738(case), Lot Number: 24JBA719; 21) DYK1060193I, UDI-DI: 10884389871737(each), 40884389871738(case), Lot Number: 24KBJ312; 22) DYK1060193I, UDI-DI: 10884389871737(each), 40884389871738(case), Lot Number: 24LBM892; 23) DYK1060193I, UDI-DI: 10884389871737(each), 40884389871738(case), Lot Number: 25BBK679; 24) DYK1060193I, UDI-DI: 10884389871737(each), 40884389871738(case), Lot Number: 25CBB540; 25) DYK1060193I, UDI-DI: 10884389871737(each), 40884389871738(case), Lot Number: 25DBA780; 26) DYK1060193I, UDI-DI: 10884389871737(each), 40884389871738(case), Lot Number: 25FBR530; 27) DYK1060193I, UDI-DI: 10884389871737(each), 40884389871738(case), Lot Number: 25GBQ911; 28) DYKMBNDL153, UDI-DI: 10193489478440(each), 40193489478441(case), Lot Number: 21ABI976; 29) DYKMBNDL153, UDI-DI: 10193489478440(each), 40193489478441(case), Lot Number: 21BBG516; 30) DYKMBNDL153, UDI-DI: 10193489478440(each), 40193489478441(case), Lot Number: 21LBJ748; 31) DYKMBNDL153, UDI-DI: 10193489478440(each), 40193489478441(case), Lot Number: 22ABO093; 32) DYKMBNDL4A, UDI-DI: 10193489904512(each), 40193489904513(case), Lot Number: 21GLA287; 33) DYKMBNDL4A, UDI-DI: 10193489904512(each), 40193489904513(case), Lot Number: 21GLA930; 34) DYKMBNDL4A, UDI-DI: 10193489904512(each), 40193489904513(case), Lot Number: 21KLA100; 35) DYKMBNDL4A, UDI-DI: 10193489904512(each), 40193489904513(case), Lot Number: 22ALA279; 36) DYKMBNDL4B, UDI-DI: 10195327200589(each), 40195327200580(case), Lot Number: 22HLB260; 37) DYKMBNDL4B, UDI-DI: 10195327200589(each), 40195327200580(case), Lot Number: 23BLA583; 38) DYKMBNDL4B, UDI-DI: 10195327200589(each), 40195327200580(case), Lot Number: 23GLA176; 39) DYKMBNDL4B, UDI-DI: 10195327200589(each), 40195327200580(case), Lot Number: 23GLA710; 40) DYKMBNDL4B, UDI-DI: 10195327200589(each), 40195327200580(case), Lot Number: 23HLA316; 41) DYKMBNDL4B, UDI-DI: 10195327200589(each), 40195327200580(case), Lot Number: 23ILA268; 42) DYKMBNDL4B, UDI-DI: 10195327200589(each), 40195327200580(case), Lot Number: 23JLA979; 43) DYKMBNDL4B, UDI-DI: 10195327200589(each), 40195327200580(case), Lot Number: 23KLA402; 44) DYKMBNDL4B, UDI-DI: 10195327200589(each), 40195327200580(case), Lot Number: 24CLA777; 45) DYKMBNDL4B, UDI
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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