Medline PPE Kit Recall Issued Over Sterility Assurance

Source: FDA · United States

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Medline Industries is recalling 13,025 units of PPE Kits (model DYK1011945P) due to potential sterility issues from equipment calibration problems.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on May 25, 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 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

Medline Convenience Kits: PPE KIT, Model Number: DYK1011945P. A total of 13,025 units distributed Worldwide - US Nationwide distribution are affected. The recall covers 44 specific lots with UDI-DI 10884389389973 (each) and 40884389389974 (case): 21BFA109, 21EFA047, 21FFA074, 21GFA025, 21HFA112, 21IFA100, 21JFA039, 21JFA139, 21KFA114, 22BFA066, 22CFA086, 22DFA081, 22IFA036, 22JFA111, 22LFA068, 23AFA049, 23AFA090, 23BFA006, 23BFA124, 23CFA070, 23DFA024, 23EFA007, 23EFA070, 23GFA079, 23HFA039, 23HFA117, 23HFA178, 23IFA139, 23JFA065, 23KFA006, 23KFA054, 23LFA050, 24BFA115, 24FFA115, 24GFA027, 24IFA085, 24JFA035, 24JFA136, 24KFA099, 25CFA033, 25DFA033, 25FFA025, 25GFA099, 25IFA006. This is FDA recall number Z-2104-2026, Class II, initiated January 7, 2026.

What You Should Do

Consumers should verify product lot numbers against the recalled list.

Why This Matters

The calibration issues have the potential to impact the sterility assurance level of the affected PPE kits distributed nationwide.

Source

FDA recall Z-2104-2026. https://www.fda.gov

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 13,025 units of PPE Kits (model DYK1011945P) due to potential sterility 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.