Medline Convenience Kits Recall Issued for Sterility Concerns
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Medline Industries, LP is recalling 1056 units of convenience kits due to potential issues with sterility assurance 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, medical-devices.
What Happened
Medline Industries, LP has initiated a voluntary recall of certain convenience kits after identifying calibration issues with the equipment used to sterilize and package the devices. Although all products were exposed to validated sterilization cycles, the calibration issues may affect the sterility assurance level.
Which Products Are Affected
The recall covers 1056 units distributed nationwide in the US and worldwide. Affected products include:
- CENTRAL LINE UNIVERSAL INSERTI (Model CVI3780), UDI-DI 10193489434866 (each)/40193489434867 (case), Lot 23KBO637 and Lot 24ABC276
- LVAD DRIVELINE TRAY (Model DM1035), UDI-DI 10193489442755 (each)/40193489442756 (case), Lot 21BBN221
- KIT SURG ONC INSERT CENT.VENOU (Model DYKMBNDL43), UDI-DI 10193489478891 (each)/40193489478892 (case), Lots 21ABJ003, 21ABO838, 21DBD662, 21IBJ337, 21JBJ253, 22CBU342, 22EBL039, 22GBF510, 22GBN333
Recall number: Z-2103-2026. Classification: Class II.
What You Should Do
Consumers should follow instructions provided by Medline Industries, LP regarding the recalled products.
Why This Matters
The potential impact on sterility assurance level of these medical devices poses a risk of contamination.
Source
FDA recall Z-2103-2026, report date 20260513.
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 (1,271 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.