FDAFDA · Food and drugs·Recall number Z-2032-2026
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SPNG NEURO 1X1 10/PK XR, Medline Kit Number/SKU DNSC38133
Published May 6, 2026 · Recall initiated: March 19, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's 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.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Medline Industries, LP
- Distributor
- Worldwide distribution.
- Lot
- UDI/DI each 10884389388655, UDI/DI case 40884389388656, Lot Numbers: 22KDA794, 22JDB440, 22ADA361, 22ADA101, 21LDC095, 21LDA462, 21JDC613, 21JDB279, 21IDC073, 21FDA437, 21EDC004, 21EDC005, 21EDB599, 21DDA592, 21CDA826, 21BDA565.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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