Medline surgical and biopsy kits recalled over sterilization equipment calibration issues
Check Medline surgical and biopsy kits for lot numbers
Medline has recalled multiple surgical and biopsy convenience kits due to calibration problems with sterilization equipment. While the kits went through standard sterilization cycles, the equipment calibration issues may have affected whether the kits are truly sterile. No injuries have been reported.
- Check if your facility has any Medline convenience kits with the affected model and lot numbers listed in the recall.
- Do not use kits matching the recalled lots until you receive instructions from Medline or your supplier.
- Contact Medline or your medical supplier for replacement kits or further 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-1392-2026More 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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