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CLASS II · ModerateFDA

Medline Industries, LP recalls Medline medical procedure kits

📅 Mar 19, 2026 · 📍 See notice
Recalling company
Medline Industries, LP
Product
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ENDOSCOPIC SKULL BASE, Medline Kit Number/SKU DYNJ58648J; 2. ENT ENDO SINUS WILMINGTON PACK, Medline Kit Number/SKU DYNJ66447; 3. ENDOSCOPIC SKULL BASE, Medline Kit Number/SKU DYNJ908362B.
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.
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
Mar 19, 2026
Reported
May 6, 2026
Distribution
Worldwide distribution.
Status
Ongoing
Quantity
1824 kits
Lot / codes
Medline Kit Number/SKU DYNJ58648J: UDI/DI each 10195327212124, UDI/DI case 40195327212125, Lot Number: 23JMD938; Medline Kit Number/SKU DYNJ58648J: UDI/DI each 10195327212124, UDI/DI case 40195327212125, Lot Number: 23HMG766; Medline Kit Number/SKU DYNJ58648J: UDI/DI each 10195327212124, UDI/DI case 40195327212125, Lot Number: 23DMD129; Medline Kit Number/SKU DYNJ58648J: UDI/DI each 10195327212124, UDI/DI case 40195327212125, Lot Number: 22KMD675; Medline Kit Number/SKU DYNJ66447: UDI/DI each 10193489356793, UDI/DI case 40193489356794, Lot Number: 23JBM687; Medline Kit Number/SKU DYNJ66447: UDI/DI each 10193489356793, UDI/DI case 40193489356794, Lot Number: 23EBD581; Medline Kit Number/SKU DYNJ66447: UDI/DI each 10193489356793, UDI/DI case 40193489356794, Lot Number: 23DBH247; Medline Kit Number/SKU DYNJ66447: UDI/DI each 10193489356793, UDI/DI case 40193489356794, Lot Number: 23CBS705; Medline Kit Number/SKU DYNJ66447: UDI/DI each 10193489356793, UDI/DI case 40193489356794, Lot Number: 23BBF189; Medline Kit Number/SKU DYNJ66447: UDI/DI each 10193489356793, UDI/DI case 40193489356794, Lot Number: 22JBF016; Medline Kit Number/SKU DYNJ66447: UDI/DI each 10193489356793, UDI/DI case 40193489356794, Lot Number: 22HBR972; Medline Kit Number/SKU DYNJ66447: UDI/DI each 10193489356793, UDI/DI case 40193489356794, Lot Number: 22DBO928; Medline Kit Number/SKU DYNJ66447: UDI/DI each 10193489356793, UDI/DI case 40193489356794, Lot Number: 22DBO407; Medline Kit Nu
Company location
Northfield, IL
Recall type
Voluntary: Firm initiated
Recall number
Z-2023-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-2023-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.