Medline surgical and catheterization kits recalled for potential sterilization issues
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
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1388-2026More Medline Industries, LP recalls
- FDA-Device2026-07-29Medline convenience kits with Bard Silastic Foley Catheters recalled for surface contamination
- FDA-Device2026-07-29Medline medical procedure kits recalled for pain medication quality issues
- FDA-Device2026-07-29Medline urology robotic procedure packs recalled for defective Bard Silastic Foley Catheters
- FDA-Device2026-07-29Medline medical convenience kits recalled for potential Bacillus contamination
- FDA-Device2026-07-29Medline convenience kits with Bard Silastic Foley Catheters recalled for surface contamination
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