FDAFDA · Food and drugs·Recall number Z-1392-2026
Medline Convenience Kits: 1) KIT SURG ONC EXCISION BREAST, Model Number: DYKMBNDL84A; 2) KIT SURG ONC EXPLORATORY LAP, Model Number: DYKMBNDL87A; 3) CT BIOPSY TRAY, Model Number: DYNDH1143C; 4) BIOPSY SPECIALS PACK, Model Number: DYNDH1873; 5) BIOPSY SPECIALS PACK, Model Number: DYNDH1934; 6) BREAST BIOPSY PACK, Model Number: DYNJ17489I; 7) VOR PACK-LF, Model Number: DYNJ48539; 8) VOR PACK-LF, Model Number: DYNJ48539A; 9) IR BIOPSY PACK, Model Number: DYNJ59897B; 10) BREAST PACK, Model Number: DYNJ82998
Published February 25, 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 distribution - US Nationwide.
- Lot
- 1) DYKMBNDL84A, UDI-DI: 10195327240486(each), 40195327240487(case), Lot Number: 23ABK216; 2) DYKMBNDL84A, UDI-DI: 10195327240486(each), 40195327240487(case), Lot Number: 22IBU924; 3) DYKMBNDL84A, UDI-DI: 10195327240486(each), 40195327240487(case), Lot Number: 22IBQ267; 4) DYKMBNDL87A, UDI-DI: 10195327240479(each), 40195327240470(case), Lot Number: 23CBL439; 5) DYKMBNDL87A, UDI-DI: 10195327240479(each), 40195327240470(case), Lot Number: 23CBC364; 6) DYKMBNDL87A, UDI-DI: 10195327240479(each), 40195327240470(case), Lot Number: 23ABU170; 7) DYKMBNDL87A, UDI-DI: 10195327240479(each), 40195327240470(case), Lot Number: 22LBM302; 8) DYKMBNDL87A, UDI-DI: 10195327240479(each), 40195327240470(case), Lot Number: 22LBK913; 9) DYNDH1143C, UDI-DI: 10193489193336(each), 40193489193337(case), Lot Number: 22GBZ268; 10) DYNDH1873, UDI-DI: 10195327486464(each), 40195327486465(case), Lot Number: 23KBK476; 11) DYNDH1934, UDI-DI: 10195327519728(each), 40195327519729(case), Lot Number: 24FMF173; 12) DYNJ17489I, UDI-DI: 10195327224783(each), 40195327224784(case), Lot Number: 23CBL337; 13) DYNJ48539, UDI-DI: 10888277906228(each), 40888277906229(case), Lot Number: 24GBD309; 14) DYNJ48539, UDI-DI: 10888277906228(each), 40888277906229(case), Lot Number: 24EBQ366; 15) DYNJ48539, UDI-DI: 10888277906228(each), 40888277906229(case), Lot Number: 24DBK656; 16) DYNJ48539, UDI-DI: 10888277906228(each), 40888277906229(case), Lot Number: 24ABL751; 17) DYNJ48539, UDI-DI: 10888277906228(each), 40888277906229(case), Lot Number: 23KBD033; 18) DYNJ48539, UDI-DI: 10888277906228(each), 40888277906229(case), Lot Number: 23HBR688; 19) DYNJ48539, UDI-DI: 10888277906228(each), 40888277906229(case), Lot Number: 23GBI270; 20) DYNJ48539, UDI-DI: 10888277906228(each), 40888277906229(case), Lot Number: 23DMD933; 21) DYNJ48539, UDI-DI: 10888277906228(each), 40888277906229(case), Lot Number: 23AMC919; 22) DYNJ48539, UDI-DI: 10888277906228(each), 40888277906229(case), Lot Number: 22EMD675; 23) DYNJ48539, UDI-DI: 10888277906228(each), 40888277906229(case), Lot Number: 22BMH767; 24) DYNJ48539, UDI-DI: 10888277906228(each), 40888277906229(case), Lot Number: 21JMC430; 25) DYNJ48539, UDI-DI: 10888277906228(each), 40888277906229(case), Lot Number: 20LMF497; 26) DYNJ48539, UDI-DI: 10888277906228(each), 40888277906229(case), Lot Number: 20LME482; 27) DYNJ48539A, UDI-DI: 10198459112133(each), 40198459112134(case), Lot Number: 25JBA908; 28) DYNJ48539A, UDI-DI: 10198459112133(each), 40198459112134(case), Lot Number: 25IBA545; 29) DYNJ48539A, UDI-DI: 10198459112133(each), 40198459112134(case), Lot Number: 25HBK043; 30) DYNJ48539A, UDI-DI: 10198459112133(each), 40198459112134(case), Lot Number: 25EBA588; 31) DYNJ48539A, UDI-DI: 10198459112133(each), 40198459112134(case), Lot Number: 24IBT900; 32) DYNJ59897B, UDI-DI: 10195327043179(each), 40195327043170(case), Lot Number: 23EBQ760; 33) DYNJ59897B, UDI-DI: 10195327043179(each), 40195327043170(case), Lot Number: 22LBH614; 34) DYNJ82998, UDI-DI: 10195327222987(each), 40195327222988(case), Lot Number: 22LMF004; 35) DYNJ82998, UDI-DI: 10195327222987(each), 40195327222988(case), Lot Number: 22JMG410
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.