Medline Cervical Pack Recall Due to Endotoxin Levels
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Medline Industries, LP is voluntarily recalling 340 medical procedure kits containing Medline Neuro Sponges due to higher-than-expected endotoxin levels, which may make the products 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, 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 identified on a representative Medline Neuro Sponge product, indicating that in-market products may be out-of-specification for endotoxin.
Which Products Are Affected
The affected products are Medline medical procedure kits labeled as CERVICAL PACK, with Kit Number/SKU DYNJ37902F. The recall involves 340 kits with Lot Numbers: 21GBA316, 21FBA411, 21DBI004, and 21BBS142. UDI/DI for each unit is 10889942930883, and for the case is 40889942930884. The distribution is worldwide.
What You Should Do
Consumers should follow the initial firm notification methods, which include email, fax, letter, press release, telephone, or visit, to get instructions from Medline Industries, LP regarding this recall.
Why This Matters
This recall highlights potential health risks from endotoxin contamination in medical devices, emphasizing the need for strict quality control to ensure product safety.
Source
Attribution: FDA. For more information, visit the FDA website.
Original source: FDA Official Notice ↗
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