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 verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
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 ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,100 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to May 13, 2026.
Frequently Asked Questions
Common questions about this FDA recall.