Medline medical convenience kits recalled for sterilization equipment calibration issues
Stop using Medline convenience kits
Medline has recalled six types of surgical and medical convenience kits due to calibration problems with sterilization equipment. While the kits went through sterilization and packaging processes, the calibration issues may have compromised the sterility of the products. No injuries have been reported.
- Check if you have any of the affected Medline kits by model number (DYKMBNDL130, DYKMBNDL130A, DYKMBNDL4, LC295, DYKM1977C, or CVI4300)
- Verify the lot number on the package against the FDA recall list
- Stop using any affected kits immediately
- Contact Medline or your healthcare facility 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-1401-2026More Medline Industries, LP recalls
- FDA-PR2026-08-05Medline Hudson RCI Neonatal/Infant Heated Wire Breathing Circuits recalled for connector overheating risk
- 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
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