Medline Convenience Kits Recall for Sterility Assurance Issues
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Medline Industries, LP has initiated a Class II recall of three burn care convenience kits due to potential impacts on sterility from equipment calibration issues.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on May 26, 2026 and geographically references United States. Its severity classification of "medium" 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 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. The recall is voluntary and firm initiated.
Which Products Are Affected
The recall affects 291 units distributed nationwide in the United States and worldwide. Affected products include:
- BURN PACK, Model Number: DYNJ15668R, UDI-DI: 10195327108502 (each), 40195327108503 (case), Lot Number: 23HMB037
- BURN PACK-LF, Model Number: DYNJ42829B, UDI-DI: 10193489880151 (each), 40193489880152 (case), Lot Number: 22IBI084
- BURN CARE PACK-LF, Model Number: DYNJT3437, UDI-DI: 10198459325076 (each), 40198459325077 (case), Lot Number: 25FBK633
Recall number: Z-2120-2026. Classification: Class II. Recall initiation date: January 7, 2026.
What You Should Do
Consumers and healthcare providers should stop using the affected products and contact the recalling firm for further instructions regarding returns.
Why This Matters
The potential impact on sterility assurance level could affect the safety of these medical devices used in burn care.
Source
FDA recall number Z-2120-2026 (event ID 98642).
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,367 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to May 26, 2026.
Frequently Asked Questions
Common questions about this FDA recall.