FDA-Device2026-02-25Class IIPROCESSING DEFECT

Medline burn care kits recalled due to sterilization equipment calibration issues

OTHERNationwide distribution

Stop using Medline burn care kits

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)
Hazard

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.

Sold states
Worldwide distribution - US Nationwide.
Affected count
291 units
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
Medline Convenience Kits: 1) BURN PACK, Model Number: DYNJ15668R; 2) BURN PACK-LF, Model Number: DYNJ42829B; 3) BURN CARE PACK-LF, Model Number: DYNJT3437

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1404-2026

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