Medline urology surgical kits recalled for potential sterilization issues
Stop using affected Medline urology kits
Medline Industries identified calibration problems with sterilization equipment used to process certain urology surgical kits. While the products went through sterilization cycles, the equipment issues may have affected whether the devices are truly sterile. This affects five models of urology kits distributed nationwide.
- Check if you have one of the affected kits by matching your lot number to the FDA notice
- Do not use affected kits; contact Medline or your supplier for instructions on returns or replacements
- If a kit has already been used, contact your healthcare provider for guidance
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-1416-2026More 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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