Medline Industries Recalls Sterile Radiology Procedure Kits

Source: FDA · United States

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Medline Industries is recalling 420 units of Sterile Radiology Procedure Kits due to a potential breach in sterile packaging that may compromise product sterility.

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

This notice was issued by FDA on April 16, 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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Medline Industries Recalls Sterile Radiology Procedure Kits

What Happened

Medline Industries, LP is recalling the product due to a potential breach in the sterile pouch packaging for one lot of radiology kits, which may compromise product sterility.

Which Products Are Affected

The affected product is Sterile Radiology Procedure Kits with Model Number DYNDH1491B. The recall involves 420 units distributed in the US nationwide, specifically in the state of MN. The product codes include UDI-DI: (CS) 40198459071455 and (EA) 10198459071454, with Lot Number: 25GBB924. The official recall number is Z-1693-2026.

What You Should Do

Consumers should follow the initial firm notification, which was issued via letter, and contact the recalling firm, Medline Industries, LP, for instructions on returns or refunds.

Why This Matters

This recall addresses potential sterility issues in medical devices, which could impact patient safety by risking contamination.

Source

Attribution: FDA. For more information, visit the FDA website at the recall event ID 98529.

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 420 units of Sterile Radiology Procedure Kits due to a potential breach in sterile packaging that may compromise product sterility.
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.