Medline Convenience Kits Recall Issued for Sterility Assurance Issues
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Medline Industries, LP is recalling 114,778 units of numerous Medline Convenience Kits due to potential impacts on sterility assurance level 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 initiated a voluntary recall after identifying calibration issues with equipment used to sterilize and package the devices. All products underwent validated sterilization cycles, but the calibration problems have the potential to affect the sterility assurance level (SAL).
Which Products Are Affected
The recall covers numerous Medline Convenience Kits, including MAJOR LAPAROTOMY CDS (models CDS860015U, CDS860015V, CDS860015W, CDS860015X), MINOR LAPAROTOMY CDS (models CDS860016P through CDS860016S), LAP GASTRIC BYPASS CDS (model CDS860146M), and many additional models such as DYKMBNDL series and DYNJ series kits. A total of 114,778 units are affected under recall number Z-2098-2026. Distribution was nationwide in the United States and worldwide.
What You Should Do
Consumers and facilities should review the FDA recall notice for specific lot details and contact Medline Industries, LP for further guidance on affected products.
Why This Matters
The potential compromise in sterility assurance level could affect the safety of surgical convenience kits used in medical procedures.
Source
FDA recall Z-2098-2026 (Class II)
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 (1,186 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.