FDA-Device2026-02-25Class IIPROCESSING DEFECT

Medline surgical and catheterization kits recalled for potential sterilization issues

OTHERNationwide distribution

Check Medline surgical kits for lot numbers

Medline discovered calibration problems with equipment used to sterilize certain surgical and catheterization convenience kits. While the kits went through sterilization cycles, the equipment issues may have affected how well they were sterilized. No injuries have been reported.

  • Check your Medline convenience kits against the recalled lot numbers listed in the FDA recall notice
  • Do not use kits with affected lot numbers
  • Contact Medline or your supplier for instructions on replacement or return
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.

Sold states
Worldwide distribution - US Nationwide.
Affected count
3561 units
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
Medline Convenience Kits: 1) ENDO KIT W/SYRINGE, Model Number: DYKE1743; 2) BGMC ANGIOGRAPHY PACK-LF, Model Number: DYNJ0800934D; 3) GENERAL ENDO PACK-LF, Model Number: DYNJ0842873J; 4) OR ANGIO PACK-LF, Model Number: DYNJ43415C; 5) ANGIO PACK II, Model Number: DYNJ44066A; 6) SOUTH CATH LAB PACK, Model Number: DYNJ61978A; 7) BIOPSY ANGIO TRAY ALEX, Model Number: DYNJ63542B; 8) SURGICAL TECH KIT, Model Number: DYNJ907452; 9) ANGIOGRAPHY PACK, Model Number: DYNJC2371G; 10) SPECTRUM HEALTH CATH PACK-LF, Model Number: PHS853965G

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1388-2026

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