Medline KIT GENERAL CLOSURE Recall Issued
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Medline Industries is recalling 108 units of KIT GENERAL CLOSURE (DYKMBNDL200A) due to potential sterility assurance issues from equipment calibration problems.
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, Devices.
What Happened
Medline Industries, LP has initiated a voluntary recall due to 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.
Which Products Are Affected
The recall affects 108 units of Medline Convenience Kits: KIT GENERAL CLOSURE, Model Number DYKMBNDL200A, distributed nationwide in the United States. Affected lot numbers include: 22KBD675, 23KBA331, 24ABH890, 24CBK339, 24FBK537, 25BBB895, 25BBS071, 25CBB549, 25DBE771, 25EBE995, 25EBG142, 25EBN454, 25FBD161, and 25HBD027. UDI-DI: 10195327240592 (each), 40195327240593 (case). Recall number Z-2121-2026. Classification: Class II.
What You Should Do
Consumers should follow instructions provided by the recalling firm regarding the affected products.
Why This Matters
The potential impact on sterility assurance level may affect the safety of these medical devices distributed nationwide.
Source
FDA recall Z-2121-2026, Medline Industries, LP, Northfield, IL.
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 (1,187 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.