Medline Convenience Kits Recall Issued for Sterility Concerns

Source: FDA · United States

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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 read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action, a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

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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 ↗

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Medline Industries, LP is recalling 1056 units of convenience kits due to potential issues with sterility assurance from equipment calibration problems.
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.