Medline Recalls Medical Procedure Kits Due to Endotoxin Levels
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
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 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, cpsc, 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 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
All FDA Recalls →Frequently Asked Questions
Common questions about this FDA recall.