Medline Recalls Medical Procedure Kits Due to Endotoxin Levels
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Medline Industries is voluntarily recalling 1824 medical procedure kits containing Medline Neuro Sponges because of higher-than-expected endotoxin levels that may make them out-of-specification.
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, cpsc, Devices.
What Happened
Medline Industries identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product during an internal review, indicating that the in-market products may not meet specifications for endotoxin.
Which Products Are Affected
The affected products are Medline medical procedure kits, specifically: 1. ENDOSCOPIC SKULL BASE with Kit Number/SKU DYNJ58648J, affected lots: 23JMD938, 23HMG766, 23DMD129, 22KMD675; 2. ENT ENDO SINUS WILMINGTON PACK with Kit Number/SKU DYNJ66447, affected lots: 23JBM687, 23EBD581, 23DBH247, 23CBS705, 23BBF189, 22JBF016, 22HBR972, 22DBO928, 22DBO407, 24ABP390, 23LBN206; 3. ENDOSCOPIC SKULL BASE with Kit Number/SKU DYNJ908362B, affected lots: 23KLA222, 23JLA551, 23ILA611, 23HLA926, 23FLA515, 23LLA801. A total of 1824 kits are affected, with worldwide distribution. The kits include UDI/DI codes such as 10195327212124 for each and 40195327212125 for cases, among others as specified in the recall details.
What You Should Do
Consumers who have these affected kits should follow the initial firm notification, which may include methods such as email, fax, letter, press release, telephone, or a visit, and contact Medline Industries, LP at their address: 3 Lakes Dr, Northfield, IL 60093-2753, for instructions on returns or refunds.
Why This Matters
This recall involves medical devices that could pose health risks due to potential endotoxin contamination, affecting 1824 kits distributed worldwide and classified as Class II by the FDA.
Source
FDA Recall Number Z-2023-2026, attributed to the FDA. For more information, refer to the FDA's recall database using event ID 98664.
Original source: FDA Official Notice ↗
Related FDA Recalls
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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 (1,666 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.