Medline Industries Recalls Burn Packs Over Sterilization Equipment Calibration Issues

What Happened

Medline Industries, LP has initiated a voluntary recall of several burn care convenience kits after identifying issues related to the calibration of equipment used to sterilize and package the devices. While all affected products were exposed to validated sterilization and packaging cycles, the calibration discrepancies have the potential to impact the sterility assurance level (SAL) of the recalled products.

Which Products Are Affected

A total of 291 units are included in this recall. The products were distributed worldwide and nationwide across the United States. The affected items include:

• BURN PACK
  • Model Number: DYNJ15668R
  • Lot Number: 23HMB037
  • UDI-DI: 10195327108502 (each), 40195327108503 (case)
• BURN PACK-LF
  • Model Number: DYNJ42829B
  • Lot Number: 22IBI084
  • UDI-DI: 10193489880151 (each), 40193489880152 (case)
• BURN CARE PACK-LF
  • Model Number: DYNJT3437
  • Lot Number: 25FBK633
  • UDI-DI: 10198459325076 (each), 40198459325077 (case)

What You Should Do

Medline Industries began notifying customers via letter on January 7, 2026. Healthcare providers and consumers should immediately check their inventory for the model and lot numbers listed above. If you possess any of the affected products, follow the instructions provided in the firm’s notification letter regarding the return or disposal of the kits. For further information, contact Medline Industries, LP at their Northfield, IL headquarters.

Why This Matters

Sterility is critical for medical devices used in burn care to prevent infection. A failure in the sterility assurance level could lead to serious health complications for patients undergoing treatment for burn injuries.

Source

This information is based on an official recall notice from the FDA. Recall Number: Z-1404-2026.