Recall of Medline PEDS AIRWAY PACK Kits Due to Endotoxin Levels
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Medline Industries is recalling 306 medical procedure kits containing Medline Neuro Sponges due to higher-than-expected endotoxin levels, 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, cpsc, Devices.
Recall Article
What Happened
Medline Industries, LP is recalling certain medical procedure kits because an internal review identified higher-than-expected endotoxin levels 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 PEDS AIRWAY PACK, Medline Kit Number SKU DYNJ86657A. A total of 306 kits are involved, with lot numbers: 26ABM977, 25KBM387, 25IBG995, and 25GBW704. The kits have UDI/DI for each: 10198459431678 and for case: 40198459431679. Distribution was worldwide.
What You Should Do
Consumers should check for the affected kits using the provided lot numbers and contact Medline Industries, LP for instructions, as the recall was initiated through methods such as email, fax, letter, press release, telephone, or visit.
Why This Matters
This recall is significant because it addresses potential health risks from endotoxin levels in medical devices, which could impact patient safety during procedures.
Source
FDA Recall Notice: Event ID 98664, Recall Number Z-2009-2026
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 (1,135 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.