Medline Industries Recalls Burn Packs Over Sterilization Equipment Calibration Issues

Source: FDA · United States

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Medline Industries, LP has issued a voluntary recall for 291 units of Burn Packs and Burn Care Packs due to equipment calibration issues that may compromise product sterility.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on March 3, 2026 and geographically references United States. Its severity classification of "high" signals how the issuing agency weighs the risk of harm if no action is taken — "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to — FDA Recalls — determines the regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action — a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

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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.

Original source: FDA Official Notice ↗

All FDA Recalls →

Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Medline Industries, LP has issued a voluntary recall for 291 units of Burn Packs and Burn Care Packs due to equipment calibration issues that may compromise product sterility.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "high" severity. Take precautions and monitor for updates.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.