Medline Convenience Kits Recall Issued

Source: FDA · United States

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Medline Industries, LP is recalling 826 units of lithotomy packs and lap basins due to potential sterility assurance issues 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 has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

Which Products Are Affected

The recall covers 826 units of Medline Convenience Kits distributed nationwide in the United States and worldwide. Affected products include:

  • LITHOTOMY PACK, Model Number: DYNJ83185 (multiple lots including 22LDA486, 23CDA474, 23CDB552, 23FDC392)
  • LITHOTOMY PACK, Model Number: DYNJ83185A (multiple lots including 23HDB637, 24CDA984, 24CDB327, 24CDB829, 24DDB769, 24EDB468, 24FDB302, 24GDB922, 24IDB525, 24KDB955)
  • LAP BASIN, Model Number: DYNJVB91109D (lot 25LLA489)

UDI-DI codes and additional lot details are provided in the recall notice. The recall number is Z-2100-2026. Classification is Class II.

What You Should Do

Consumers should follow instructions provided in the firm's notification letter regarding the recalled products.

Why This Matters

The calibration issues have the potential to impact the sterility assurance level of the affected devices.

Source

FDA recall Z-2100-2026, 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, LP is recalling 826 units of lithotomy packs and lap basins due to potential sterility assurance issues 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.