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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. MAJOR NEURO PACK-LF, Medline Kit Number/SKU DYNJ0578916X; 2. ANGIOGRAPHY PACK, Medline Kit Number/SKU DYNJ51637D; 3. NEURO SEO, Medline Kit Number/SKU DYNJ65650.
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
3170 kits
Lot / codes
Medline Kit Number/SKU DYNJ0578916X: UDI/DI each 10193489288384, UDI/DI case 40193489288385, Lot Number: 23IME618; Medline Kit Number/SKU DYNJ0578916X: UDI/DI each 10193489288384, UDI/DI case 40193489288385, Lot Number: 23FMF542; Medline Kit Number/SKU DYNJ0578916X: UDI/DI each 10193489288384, UDI/DI case 40193489288385, Lot Number: 23DMA094; Medline Kit Number/SKU DYNJ0578916X: UDI/DI each 10193489288384, UDI/DI case 40193489288385, Lot Number: 23AMD730; Medline Kit Number/SKU DYNJ0578916X: UDI/DI each 10193489288384, UDI/DI case 40193489288385, Lot Number: 22GMB685; Medline Kit Number/SKU DYNJ0578916X: UDI/DI each 10193489288384, UDI/DI case 40193489288385, Lot Number: 22DMI233; Medline Kit Number/SKU DYNJ0578916X: UDI/DI each 10193489288384, UDI/DI case 40193489288385, Lot Number: 22DMC612; Medline Kit Number/SKU DYNJ0578916X: UDI/DI each 10193489288384, UDI/DI case 40193489288385, Lot Number: 24AMA230; Medline Kit Number/SKU DYNJ51637D: UDI/DI each 10195327632106, UDI/DI case 40195327632107, Lot Number: 24GMI248; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 23JMK002; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 23JME739; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 23IBJ883; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 23EB
Company location
Northfield, IL
Recall type
Voluntary: Firm initiated
Recall number
Z-2015-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-2015-2026 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.