Medline burn care kits recalled due to sterilization equipment calibration issues
What this means
Medline has recalled three models of burn care convenience kits because equipment used to sterilize and package them had calibration problems. While the products went through sterilization cycles, the calibration issues may have affected whether the kits are properly sterile. No injuries have been reported.
- Check if you have Medline burn kits with model numbers DYNJ15668R, DYNJ42829B, or DYNJT3437
- Do not use affected kits; contact Medline or your supplier for instructions on return or replacement
- Verify the lot number on your kit matches the recall (23HMB037, 22IBI084, or 25FBK633)
The agency's original wording
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-1404-2026More Medline recalls
- FDA-Device2026-09-09Medline Convenience Kits recalled for potential sterility breach in antiseptic applicators
- FDA-Device2026-09-09Medline Convenience Kits with BD ChloraPrep Clear applicators recalled for contamination risk
- FDA-Device2026-09-09Medline Convenience Kits recalled for sterility packaging breach risk
- FDA-Device2026-09-09Medline Convenience Kits with BD ChloraPrep Clear applicators recalled for defective packaging seals
- FDA-Device2026-09-09Medline Arterial Line Insertion Kit recalled for sterility packaging breach risk
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