Medium risk Medical DevicesClass II

Medline Neuro Sponge Procedure Kits Recall

Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. CATARACT PACK, Medline Kit Number/SKU DYNJ48725A; 2

Updated March 19, 2026

Medline medical procedure kits containing neuro sponges have been recalled because some units contain higher-than-expected endotoxin levels, which can cause an inflammatory reaction during surgical use. Healthcare facilities should stop using affected kits and contact Medline or their supplier for further instructions.

Is the Medline Industries, LP recalled? Yes. This product was recalled by FDA on March 19, 2026. Details below.

What is recalled

Medline medical procedure kits containing Medline Neuro Sponges: Cataract Pack (SKU DYNJ48725A), Ocular Pack (SKU DYNJ64138B), Oculoplasty Pack (SKU DYNJ64572A and DYNJ64572B), Microsurgery Pack (SKU DYNJ67284A), Basic Eye Pack (SKU DYNJ81411A), SMR Sinus Pack (SKU DYNJ84478), FESS/Septo Pack (SKU DYNJ85025), Plastic Eye Pack (SKU DYNJ89030), Neuro (SKU DYNJ902935K), Ocular (SKU DYNJ909065 and DYNJ909065A).

Am I affected

You're affected if your healthcare facility has any of the Medline procedure kits listed above, identified by their SKU/Kit Number on the package label. Check your inventory against the complete SKU list.

What to do right now

Stop using these kits immediately. Contact your Medline supplier or Medline Industries directly for instructions on return or replacement of affected inventory.

The hazard

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.

Brands affected

Source
FDA
Category
Medical Devices
Recall ID
fda-Z-2037-2026
Classification
Class II
Recalled
March 19, 2026
Read the official notice

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