Medline EH Bronchoscopy Kit Recall

Source: FDA · Worldwide

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Medline Industries is recalling 152 medical procedure kits due to higher-than-expected endotoxin levels in the included neuro sponges.

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

This notice was issued by FDA on May 14, 2026 and geographically references Worldwide. 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.

For decision-making, Areazine pairs each alert with the original agency URL, the full agency name, and a timestamp so you can verify the notice against the primary source before acting on it. Tags on this item (recall, product-safety, fda, Devices) map to related alerts in the same area of risk - browsing them together gives a clearer picture than any single notice alone, because the shape of an ongoing issue only becomes visible across multiple sequential alerts.

What Happened

Medline Industries, LP is recalling certain medical procedure kits because an internal review identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that the in-market product may be out-of-specification for endotoxin. This is a voluntary recall initiated by the firm.

Which Products Are Affected

The affected products are Medline medical procedure kits labeled as EH BRONCHOSCOPY, with Kit Number/SKU DYNJT3270. The recall involves 152 kits with the following details: UDI/DI for each unit is 10198459322235, UDI/DI for case is 40198459322236, and Lot Numbers are 26AMF231, 25GMC304, and 25DMF469. These products were distributed worldwide.

What You Should Do

Consumers who have these kits should follow the firm's initial notification, which was made through methods such as email, fax, letter, press release, telephone, or visit. Contact Medline Industries, LP at their address: 3 Lakes Dr, Northfield, IL 60093-2753, for instructions on returns or refunds related to recall number Z-2010-2026.

Why This Matters

This recall addresses potential safety concerns due to out-of-specification endotoxin levels in medical devices, which could affect patient health. It highlights the importance of quality control in medical products distributed worldwide.

Source

This information is from the FDA recall notice, event ID 98664.

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 152 medical procedure kits due to higher-than-expected endotoxin levels in the included neuro sponges.
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 Worldwide. 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.