← FDA ENFORCEMENT
Z-2009-2026Class II

Medline Industries, LP

Recalling firm
Medline Industries, LP
Product type
Device
Status
Ongoing
Report date
2026-05-06
Distribution
Worldwide distribution.
Firm state
IL
Product quantity
306 kits
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.

Product description

Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: PEDS AIRWAY PACK, Medline Kit Number SKU DYNJ86657A

Code / lot info

Medline Kit Number SKU DYNJ86657A: UDI/DI each 10198459431678, UDI/DI case 40198459431679, Lot Numbers: 26ABM977, 25KBM387, 25IBG995, 25GBW704.

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.