Medline Industries Recalls General Closure Convenience Kits Over Sterility Assurance Concerns
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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 April 6, 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, medical-device.
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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