Medical device recalls Moderate risk

Medline Industries, LP recalls Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ZALE STEREOTACTIC CDS, Medline…

Recall date
March 19, 2026
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2020-2026
FDA classification
Class II
Brand / firm
Medline Industries, LP
Sold / distributed
Worldwide distribution.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ZALE STEREOTACTIC CDS, Medline Kit Number/SKU CDS983173G; 2. EPISTAXIS TRAY, Medline Kit Number/SKU DYNDA3240; 3. RHINO PACK, Medline Kit Number/SKU DYNJ46504B; 4. MSC SEPTO RHINO PACK-LF, Medline Kit Number/SKU DYNJ51677B; 5. RHINO/SEPTO/FESS PACK, Medline Kit Number/SKU DYNJ55955C; 6. NASAL PACK, Medline Kit Number/SKU DYNJ67789A.

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