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-Device2026-06-03Medline EYE TRAY-LF medical kit recalled for mismatched syringes
- FDA-Device2026-06-03Medline spinal anesthesia and nerve block kits recalled for bupivacaine quality and efficacy concerns
- FDA-Device2026-05-20Medline Namic Preceptor blood pressure manifold recalled for particulate contamination
- FDA-Device2026-05-20Medline TAVI medical convenience kits recalled for particulate contamination in fluid path
- FDA-Device2026-05-20Medline medical convenience kits with Namic Manifold recalled for particulate contamination
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