Medline Industries, LP: Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. NEURO PACK, Medline kit number/SKU DYNJ64479;
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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Medline Industries, LP
- Product
- Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. NEURO PACK, Medline kit number/SKU DYNJ64479; 2. CRANIO/NEURO/SPINE, Medline kit number/SKU DYNJ901072D.
- Reason / 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.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- Worldwide distribution.
- Recall initiated
- 2026-03-19
- Code info
- Medline Kit Number/SKU DYNJ86657A, UDI/DI each 10198459431678, UDI/DI case 40198459431679, Lot Number: 26ABM977; Medline Kit Number/SKU DYNJ86657A, UDI/DI each 10198459431678, UDI/DI case 40198459431679, Lot Number: 25KBM387; Medline Kit Number/SKU DYNJ86657A, UDI/DI each 10198459431678, UDI/DI case 40198459431679, Lot Number: 25IBG995; Medline Kit Number/SKU DYNJ86657A, UDI/DI each 10198459431678, UDI/DI case 40198459431679, Lot Number: 25GBW704; Medline Kit Number/SKU DYNJT3270, UDI/DI each 10198459322235, UDI/DI case 40198459322236, Lot Number: 26AMF231; Medline Kit Number/SKU DYNJT3270, UDI/DI each 10198459322235, UDI/DI case 40198459322236, Lot Number: 25GMC304.
- Product quantity
- 413 kits
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Northfield
- State
- IL
- Country
- United States
- Event id
- 98664
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