Medline Industries Recalls Burn Packs Over Sterilization Equipment Calibration Issues
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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 April 6, 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 consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency 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 verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, MedicalDevices.
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 ↗
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