Medline surgical convenience kits recalled for sterilization equipment calibration issues
Check Medline surgical kits for proper sterilization
Medline Industries identified calibration problems with equipment used to sterilize and package two types of surgical convenience kits: Ancillary Pack-LF and Open Heart Anesthesia ICC-A. Although these products went through sterilization cycles, the equipment calibration issues may have affected whether the kits are fully sterile. This recall affects 551 units distributed nationwide.
- Check if you have Medline surgical kits matching the recalled model and lot numbers listed in the FDA notice
- Contact Medline Industries or the FDA with questions about your specific lot number
- Do not use recalled kits for procedures until you confirm your lot is not affected
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-1384-2026More 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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