FDAHealthMarch 19, 2026
Medline Industries, LP — Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SPINAL FUSION, Medline Kit Number/SKU CDS860017AG
⚠️ 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.
Is this relevant to me?
- Geography
- Unknown
- Source agency
- FDA
- Category
- Health
- Published
- March 19, 2026
Worldwide distribution.
What's affected?
- Product
- Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SPINAL FUSION, Medline Kit Number/SKU CDS860017AG
- Lot code
- 25LBI308
Additional details
UDI/DI each 10198459237317, UDI/DI case 40198459237318: Lot Numbers: 25LBI308, 25JBH227, 25HBQ371, 25HBP069, 25GBQ494, 25FBM672, 25CBF603, 25BBG224, 25ABN190, 25ABN214.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 120 kits.
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