Medline Industries Recalls General Closure Convenience Kits Over Sterility Assurance Concerns

Source: FDA · United States

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Medline Industries, LP is recalling 108 units of its General Closure Convenience Kits (Model DYKMBNDL200A) because equipment calibration issues may have compromised the sterility of the devices.

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 "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 regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who holds statutory responsibility for enforcement.

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What Happened

Medline Industries, LP has initiated a voluntary recall of specific convenience kits used for general closures. The company identified issues related to the calibration of equipment used during the sterilization and packaging process. Although the products were exposed to validated sterilization cycles, the calibration discrepancies have the potential to impact the sterility assurance level (SAL) of the devices.

Which Products Are Affected

The recall affects the Medline Convenience Kits: KIT GENERAL CLOSURE, specifically Model Number: DYKMBNDL200A. A total of 108 units are included in this recall.

The affected products can be identified by the following codes:

  • UDI-DI: 10195327240592 (each), 40195327240593 (case)
  • Lot Numbers: 25HBD027, 25FBD161, 25EBN454, 25EBG142, 25EBE995, 25DBE771, 25CBB549, 25BBS071, 25BBB895, 24FBK537, 24CBK339, 24ABH890, 23KBA331, and 22KBD675.

The distribution of these products was nationwide across the United States and worldwide.

What You Should Do

Medline Industries notified affected customers via a formal letter. Facilities and healthcare providers should immediately check their inventory for the model and lot numbers listed above. Affected products should be quarantined and handled according to the instructions provided by Medline. For further information or to coordinate returns, contact Medline Industries, LP at 3 Lakes Dr, Northfield, IL 60093.

Why This Matters

The sterility of medical devices is critical for patient safety. If the sterility assurance level is compromised, there is an increased risk of infection or other adverse health consequences for patients undergoing procedures where these kits are used.

Source

Information provided by the FDA under recall number Z-1405-2026.

Original source: FDA Official Notice ↗

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Medline Industries, LP is recalling 108 units of its General Closure Convenience Kits (Model DYKMBNDL200A) because equipment calibration issues may have compromised the sterility of the devices.
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 "medium" severity. Stay informed and follow agency guidance.
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.