Devices/Recall·openFDA/device

Medline Industries, LP — Class II: Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1.

MediumPublished May 6, 2026· AI-analyzed May 11, 2026View original FDA source

AI-generated regulatory interpretation. The four sections below are an analyst-style summary produced by an AI model from the original FDA source. Always verify against the source before any regulatory, clinical, or commercial decision.

What happened

Medline Industries, LP has initiated a Class II recall for various medical procedure kits containing Medline Neuro Sponges after an internal review identified endotoxin levels exceeding established specifications.

Who it affects

The recall affects Medline Industries, LP and healthcare facilities utilizing various ophthalmic, microsurgery, sinus, and neurosurgical procedure kits (DYNJ SKUs) containing neuro sponges.

Why it matters

The presence of out-of-specification endotoxin levels in surgical components suggests a potential breakdown in sterility assurance or raw material qualification processes. For regulatory teams, this highlights the necessity of robust monitoring for sub-components within convenience kits, as a single non-compliant item necessitates the recall of the entire multi-component procedure pack.

Practical takeaway

Identify and quarantine affected kit SKUs (DYNJ series) within inventory; initiate reconciliation between kit components and supplier specifications; review internal endotoxin testing protocols for neuro-surgical accessories to ensure alignment with specifications.

FDA source material

Class II. Reason: 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: 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.. Firm: Medline Industries, LP (Northfield IL United States). Status: Ongoing.

Open in openFDA / FDA.gov

AI-generated interpretation. Always verify critical decisions against the original FDA source. Generated with google/gemini-3-flash-preview.

Medline Industries, LP — Class II: Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1.

More from Devices