Medline ANGIO PACK-LF Recall Over Endotoxin Levels
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Medline Industries is recalling 160 medical procedure kits due to higher-than-expected endotoxin levels in the included neuro sponges, affecting worldwide distribution.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on May 13, 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 identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, leading to the recall of affected medical procedure kits as they may be out-of-specification for endotoxin.
Which Products Are Affected
The affected products are Medline medical procedure kits labeled as ANGIO PACK-LF, with Medline Kit Number/SKU DYNJ0774765U. The recall involves 160 kits, with UDI/DI each 10193489634594, UDI/DI case 40193489634595, and Lot Number 24ILA931. These kits were distributed worldwide.
What You Should Do
Consumers should stop using the affected kits and contact Medline Industries, LP for further instructions, as the firm initiated the recall through methods such as email, fax, letter, press release, telephone, or visit.
Why This Matters
This recall addresses potential health risks from out-of-specification endotoxin levels in medical devices, emphasizing the importance of product safety in healthcare settings.
Source
FDA Recall Number Z-2014-2026, attributed to the U.S. Food and Drug Administration (FDA).
Original source: FDA Official Notice ↗
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