Medline medical procedure kits recall: Endotoxin
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.
Why was Medline medical procedure kits recalled?
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 should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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: 23EBO648; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 23ABT378; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 22KBG029; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 22JBF057; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 22IBL935; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 22FBD348; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 22DBP280; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 22BBB689; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 22ABT749; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 21KBX317; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 21JBZ013; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 21JBB969; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 21IBB479; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 21GBL057; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 21BBL823; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 26AMH608; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 25LMB913; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 25HMI678; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 25GMK494; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 25FMH605; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 25DMA861; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 25BMB215; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 24JMJ380; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 24FMD882; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 24EMD977; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 24DMF834; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 24BMJ374; Medline Kit Number/SKU DYNJ65650: UDI/DI each 10193489285642, UDI/DI case 40193489285643, Lot Number: 23LMF318.
- 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.
- Recalling firm
- Medline Industries, LP
- Quantity
- 3170 kits
- Distribution
- Worldwide distribution.
- Recall date
- May 6, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)