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) C T BIOPSY TRAY-LF, Model Number:DYNJ17558D; 8) RIGHT HEART BIOPSY TRAY, Model Number:DYNJ19063K; 9) VOR PACK-LF, Model Number:DYNJ48539; 10) VOR PACK-LF, Model Number:DYNJ48539A; 11) IR BIOPSY PACK, Model Number:DYNJ59897B; 12) BREAST PACK, Model Number:DYNJ82998; 13) LIVER BIOPSY KIT, Model Number:DYNJ910654
Class I - DangerousWhat Should You Do?
- Check if you have this product: 1) DYKMBNDL84A, UDI-DI: 10195327240486(each), 40195327240487(case), Lot Number: 22IBQ267; 2) DYKMBNDL84A, UDI-DI: 10195327240486(each), 40195327240487(case), Lot Number: 22IBU924; 3) DYKMBNDL84A, UDI-DI: 10195327240486(each), 40195327240487(case), Lot Number: 23ABK216; 4) DYKMBNDL87A, UDI-DI: 10195327240479(each), 40195327240470(case), Lot Number: 22LBK913; 5) DYKMBNDL87A, UDI-DI: 10195327240479(each), 40195327240470(case), Lot Number: 22LBM302; 6) DYKMBNDL87A, UDI-DI: 10195327240479(each), 40195327240470(case), Lot Number: 23ABU170; 7) DYKMBNDL87A, UDI-DI: 10195327240479(each), 40195327240470(case), Lot Number: 23CBC364; 8) DYKMBNDL87A, UDI-DI: 10195327240479(each), 40195327240470(case), Lot Number: 23CBL439; 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) DYNJ17558D, UDI-DI: 10195327504205(each), 40195327504206(case), Lot Number: 23JLB107; 14) DYNJ19063K, UDI-DI: 10888277828025(each), 40888277828026(case), Lot Number: 24DBL079; 15) DYNJ48539, UDI-DI: 10888277906228(each), 40888277906229(case), Lot Number: 20LME482; 16) DYNJ48539, UDI-DI: 10888277906228(each), 40888277906229(case), Lot Number: 20LMF497; 17) DYNJ48539, UDI-DI: 10888277906228(each), 40888277906229(case), Lot Number: 21JMC430; 18) DYNJ48539, UDI-DI: 10888277906228(each), 40888277906229(case), Lot Number: 22BMH767; 19) DYNJ48539, UDI-DI: 10888277906228(each), 40888277906229(case), Lot Number: 22EMD675; 20) DYNJ48539, UDI-DI: 10888277906228(each), 40888277906229(case), Lot Number: 23AMC919; 21) DYNJ48539, UDI-DI: 10888277906228(each), 40888277906229(case), Lot Number: 23DMD933; 22) DYNJ48539, UDI-DI: 10888277906228(each), 40888277906229(case), Lot Number: 23GBI270; 23) DYNJ48539, UDI-DI: 10888277906228(each), 40888277906229(case), Lot Number: 23HBR688; 24) DYNJ48539, UDI-DI: 10888277906228(each), 40888277906229(case), Lot Number: 23KBD033; 25) DYNJ48539, UDI-DI: 10888277906228(each), 40888277906229(case), Lot Number: 24ABL751; 26) DYNJ48539, UDI-DI: 10888277906228(each), 40888277906229(case), Lot Number: 24DBK656; 27) DYNJ48539, UDI-DI: 10888277906228(each), 40888277906229(case), Lot Number: 24EBQ366; 28) DYNJ48539, UDI-DI: 10888277906228(each), 40888277906229(case), Lot Number: 24GBD309; 29) DYNJ48539A, UDI-DI: 10198459112133(each), 40198459112134(case), Lot Number: 24IBT900; 30) DYNJ48539A, UDI-DI: 10198459112133(each), 40198459112134(case), Lot Number: 25EBA588; 31) DYNJ48539A, UDI-DI: 10198459112133(each), 40198459112134(case), Lot Number: 25HBK043; 32) DYNJ48539A, UDI-DI: 10198459112133(each), 40198459112134(case), Lot Number: 25IBA545; 33) DYNJ48539A, UDI-DI: 10198459112133(each), 40198459112134(case), Lot Number: 25JBA908; 34) DYNJ59897B, UDI-DI: 10195327043179(each), 40195327043170(case), Lot Number: 22LBH614; 35) DYNJ59897B, UDI-DI: 10195327043179(each), 40195327043170(case), Lot Number: 23EBQ760; 36) DYNJ59897B, UDI-DI: 10195327043179(each), 40195327043170(case), Lot Number: 23FBT785; 37) DYNJ59897B, UDI-DI: 10195327043179(each), 40195327043170(case), Lot Number: 23LBA546; 38) DYNJ82998, UDI-DI: 10195327222987(each), 40195327222988(case), Lot Number: 22JMG410; 39) DYNJ82998, UDI-DI: 10195327222987(each), 40195327222988(case), Lot Number: 22LMF004; 40) DYNJ910654, UDI-DI: 10198459055843(each), 40198459055844(case), Lot Number: 25CBM821; 41) DYNJ910654, UDI-DI: 10198459055843(each), 40198459055844(case), Lot Number: 25DBP029; 42) DYNJ910654, UDI-DI: 10198459055843(each), 40198459055844(case), Lot Number: 25EBU142; 43) DYNJ910654, UDI-DI: 10198459055843(each), 40198459055844(case), Lot Number: 25GBO011; 44) DYNJ910654, UDI-DI: 10198459055843(each), 40198459055844(case), Lot Number: 25HBG682
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Medline Industries, LP
- Reason for Recall:
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
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) C T BIOPSY TRAY-LF, Model Number:DYNJ17558D; 8) RIGHT HEART BIOPSY TRAY, Model Number:DYNJ19063K; 9) VOR PACK-LF, Model Number:DYNJ48539; 10) VOR PACK-LF, Model Number:DYNJ48539A; 11) IR BIOPSY PACK, Model Number:DYNJ59897B; 12) BREAST PACK, Model Number:DYNJ82998; 13) LIVER BIOPSY KIT, Model Number:DYNJ910654
Product Codes/Lot Numbers:
1) DYKMBNDL84A, UDI-DI: 10195327240486(each), 40195327240487(case), Lot Number: 22IBQ267; 2) DYKMBNDL84A, UDI-DI: 10195327240486(each), 40195327240487(case), Lot Number: 22IBU924; 3) DYKMBNDL84A, UDI-DI: 10195327240486(each), 40195327240487(case), Lot Number: 23ABK216; 4) DYKMBNDL87A, UDI-DI: 10195327240479(each), 40195327240470(case), Lot Number: 22LBK913; 5) DYKMBNDL87A, UDI-DI: 10195327240479(each), 40195327240470(case), Lot Number: 22LBM302; 6) DYKMBNDL87A, UDI-DI: 10195327240479(each), 40195327240470(case), Lot Number: 23ABU170; 7) DYKMBNDL87A, UDI-DI: 10195327240479(each), 40195327240470(case), Lot Number: 23CBC364; 8) DYKMBNDL87A, UDI-DI: 10195327240479(each), 40195327240470(case), Lot Number: 23CBL439; 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) DYNJ17558D, UDI-DI: 10195327504205(each), 40195327504206(case), Lot Number: 23JLB107; 14) DYNJ19063K, UDI-DI: 10888277828025(each), 40888277828026(case), Lot Number: 24DBL079; 15) DYNJ48539, UDI-DI: 10888277906228(each), 40888277906229(case), Lot Number: 20LME482; 16) DYNJ48539, UDI-DI: 10888277906228(each), 40888277906229(case), Lot Number: 20LMF497; 17) DYNJ48539, UDI-DI: 10888277906228(each), 40888277906229(case), Lot Number: 21JMC430; 18) DYNJ48539, UDI-DI: 10888277906228(each), 40888277906229(case), Lot Number: 22BMH767; 19) DYNJ48539, UDI-DI: 10888277906228(each), 40888277906229(case), Lot Number: 22EMD675; 20) DYNJ48539, UDI-DI: 10888277906228(each), 40888277906229(case), Lot Number: 23AMC919; 21) DYNJ48539, UDI-DI: 10888277906228(each), 40888277906229(case), Lot Number: 23DMD933; 22) DYNJ48539, UDI-DI: 10888277906228(each), 40888277906229(case), Lot Number: 23GBI270; 23) DYNJ48539, UDI-DI: 10888277906228(each), 40888277906229(case), Lot Number: 23HBR688; 24) DYNJ48539, UDI-DI: 10888277906228(each), 40888277906229(case), Lot Number: 23KBD033; 25) DYNJ48539, UDI-DI: 10888277906228(each), 40888277906229(case), Lot Number: 24ABL751; 26) DYNJ48539, UDI-DI: 10888277906228(each), 40888277906229(case), Lot Number: 24DBK656; 27) DYNJ48539, UDI-DI: 10888277906228(each), 40888277906229(case), Lot Number: 24EBQ366; 28) DYNJ48539, UDI-DI: 10888277906228(each), 40888277906229(case), Lot Number: 24GBD309; 29) DYNJ48539A, UDI-DI: 10198459112133(each), 40198459112134(case), Lot Number: 24IBT900; 30) DYNJ48539A, UDI-DI: 10198459112133(each), 40198459112134(case), Lot Number: 25EBA588; 31) DYNJ48539A, UDI-DI: 10198459112133(each), 40198459112134(case), Lot Number: 25HBK043; 32) DYNJ48539A, UDI-DI: 10198459112133(each), 40198459112134(case), Lot Number: 25IBA545; 33) DYNJ48539A, UDI-DI: 10198459112133(each), 40198459112134(case), Lot Number: 25JBA908; 34) DYNJ59897B, UDI-DI: 10195327043179(each), 40195327043170(case), Lot Number: 22LBH614; 35) DYNJ59897B, UDI-DI: 10195327043179(each), 40195327043170(case), Lot Number: 23EBQ760; 36) DYNJ59897B, UDI-DI: 10195327043179(each), 40195327043170(case), Lot Number: 23FBT785; 37) DYNJ59897B, UDI-DI: 10195327043179(each), 40195327043170(case), Lot Number: 23LBA546; 38) DYNJ82998, UDI-DI: 10195327222987(each), 40195327222988(case), Lot Number: 22JMG410; 39) DYNJ82998, UDI-DI: 10195327222987(each), 40195327222988(case), Lot Number: 22LMF004; 40) DYNJ910654, UDI-DI: 10198459055843(each), 40198459055844(case), Lot Number: 25CBM821; 41) DYNJ910654, UDI-DI: 10198459055843(each), 40198459055844(case), Lot Number: 25DBP029; 42) DYNJ910654, UDI-DI: 10198459055843(each), 40198459055844(case), Lot Number: 25EBU142; 43) DYNJ910654, UDI-DI: 10198459055843(each), 40198459055844(case), Lot Number: 25GBO011; 44) DYNJ910654, UDI-DI: 10198459055843(each), 40198459055844(case), Lot Number: 25HBG682
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2095-2026
Related Recalls
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.