Medline Convenience Kits Recall Due to Sterilization Issues

Source: FDA · United States

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Medline Industries is recalling 599 units of two convenience kit models after identifying calibration issues with sterilization equipment that may affect sterility assurance.

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 due to calibration issues with the equipment used to sterilize and package the devices. Although all products were exposed to validated sterilization cycles, the calibration problems have the potential to impact the sterility assurance level (SAL).

Which Products Are Affected

The recall covers 599 units distributed nationwide in the United States and worldwide. Affected products include:

  • ANCILLARY PACK-LF (Model DYNJ0185290G, Lot 22LBQ336, UDI-DI 10193489378054 each / 40193489378055 case)
  • OPEN HEART ANESTHESIA ICC-A (Model DYNJ905567A) in the following lots: 21EBE777, 21GBE802, 21IBH675, 21KBA253, 21KBR457, 22CBY841, 22HBF686, 22HBM263, 22HBP453, 22LBC300, 22NBF780, 23CBQ546, 23EBH550, 23FBG152, 23FBL644, 23HBG596, 23KBI089, 24BBN429, 24GBT983, 24HBP446 (UDI-DI 10193489348927 each / 40193489348928 case)

This is FDA Recall Number Z-2089-2026, classified as Class II.

What You Should Do

Consumers and facilities should check inventory for the listed lots and contact Medline Industries for return or replacement instructions.

Why This Matters

The potential reduction in sterility assurance level could compromise the safety of devices used in surgical and anesthesia procedures.

Source

FDA recall Z-2089-2026, Medline Industries, LP, Northfield, IL.

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 is recalling 599 units of two convenience kit models after identifying calibration issues with sterilization equipment that may affect sterility assurance.
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.