Medline Medical Procedure Kits Recall

Source: FDA · Worldwide

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Medline Industries is recalling 3290 medical procedure kits due to higher-than-expected endotoxin levels in included neuro sponges, potentially affecting product safety.

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 of higher-than-expected endotoxin levels on the included Medline Neuro Sponges, as identified during an internal review.

Which Products Are Affected

The affected products are various Medline medical procedure kits, including: 1. CATARACT PACK (SKU DYNJ48725A), 2. OCULAR PACK (SKU DYNJ64138B), 3. OCULOPLASTY PACK (SKU DYNJ64572A), 4. OCULOPLASTY PACK (SKU DYNJ64572B), 5. MICROSURGERY PACK (SKU DYNJ67284A), 6. BASIC EYE PACK (SKU DYNJ81411A), 7. SMR SINUS PACK (SKU DYNJ84478), 8. FESS/SEPTO PACK (SKU DYNJ85025), 9. PLASTIC EYE PACK (SKU DYNJ89030), 10. NEURO (SKU DYNJ902935K), 11. OCULAR (SKU DYNJ909065), and 12. OCULAR (SKU DYNJ909065A). A total of 3290 kits are affected, distributed worldwide, with specific lot numbers such as 24IMG757 for DYNJ48725A, 22FME241 for DYNJ64138B, and others as detailed in the FDA notice.

What You Should Do

Consumers should stop using the affected kits immediately and contact Medline Industries, LP for instructions on returns or refunds. The firm notified customers via email, fax, letter, press release, telephone, or visit.

Why This Matters

This recall highlights potential risks from endotoxin contamination in medical devices, which could lead to adverse health effects, underscoring the need for strict quality standards in healthcare products.

Source

FDA Recall Number: Z-2037-2026. For more information, refer to the FDA website at https://www.fda.gov (attribution to FDA enforcement report).

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 3290 medical procedure kits due to higher-than-expected endotoxin levels in included neuro sponges, potentially affecting product safety.
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.