Medical device recalls Moderate risk

Medline Industries, LP recalls Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. CATARACT PACK, Medline Kit Num…

Recall date
March 19, 2026
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2037-2026
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. CATARACT PACK, Medline Kit Number/SKU DYNJ48725A; 2. OCULAR PACK, Medline Kit Number/SKU DYNJ64138B; 3. OCULOPLASTY PACK, Medline Kit Number/SKU DYNJ64572A; 4. OCULOPLASTY PACK, Medline Kit Number/SKU DYNJ64572B; 5. MICROSURGERY PACK, Medline Kit Number/SKU DYNJ67284A; 6. BASIC EYE PACK, Medline Kit Number/SKU DYNJ81411A; 7. SMR SINUS PACK, Medline Kit Number/SKU DYNJ84478; 8. FESS/SEPTO PACK, Medline Kit Number/SKU DYNJ85025; 9. PLASTIC EYE PACK, Medline Kit Number/SKU DYNJ89030; 10. NEURO, Medline Kit Number/SKU DYNJ902935K; 11. OCULAR, Medline Kit Number/SKU DYNJ909065; 12. OCULAR, Medline Kit Number/SKU DYNJ909065A.

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