Medline Cervical Pack Recall 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, 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 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 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 ↗
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 (1,112 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.