FDAFDA · Food and drugs·Recall number Z-2038-2026
Medline medical procedure kits, containing Medline Neuro Sponges (4077 in total), LAMINECTOMY, CRANI, etc.
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
- Medline Kit Number/SKU CDS780045N: UDI/DI each 10193489355406, UDI/DI case 40193489355407, Lot Number: 23CBR748; Medline Kit Number/SKU CDS780045N: UDI/DI each 10193489355406, UDI/DI case 40193489355407, Lot Number: 22LBP661; Medline Kit Number/SKU CDS780045N: UDI/DI each 10193489355406, UDI/DI case 40193489355407, Lot Number: 22JBI816; Medline Kit Number/SKU CDS780045N: UDI/DI each 10193489355406, UDI/DI case 40193489355407, Lot Number: 22JBI817; Medline Kit Number/SKU CDS780045N: UDI/DI each 10193489355406, UDI/DI case 40193489355407, Lot Number: 22GBG444; Medline Kit Number/SKU CDS780045N: UDI/DI each 10193489355406, UDI/DI case 40193489355407, Lot Number: 22GBG445; Medline Kit Number/SKU CDS780045N: UDI/DI each 10193489355406, UDI/DI case 40193489355407, Lot Number: 22FBM376; Medline Kit Number/SKU CDS780045N: UDI/DI each 10193489355406, UDI/DI case 40193489355407, Lot Number: 22DBB694; Medline Kit Number/SKU CDS780045N: UDI/DI each 10193489355406, UDI/DI case 40193489355407, Lot Number: 22DBA187; Medline Kit Number/SKU CDS780045N: UDI/DI each 10193489355406, UDI/DI case 40193489355407, Lot Number: 21LBP574; Medline Kit Number/SKU CDS780045N: UDI/DI each 10193489355406, UDI/DI case 40193489355407, Lot Number: 21JBU289; Medline Kit Number/SKU CDS780045N: UDI/DI each 10193489355406, UDI/DI case 40193489355407, Lot Number: 21FBS507; Medline Kit Number/SKU CDS780045N: UDI/DI each 10193489355406, UDI/DI case 40193489355407, Lot Number: 21FBL891; Medline Kit Number/SKU CDS780045N: UDI/DI each 10193489355406, UDI/DI case 40193489355407, Lot Number: 21BBF167; Medline Kit Number/SKU CDS780045O: UDI/DI each 10195327362638, UDI/DI case 40195327362639, Lot Number: 23FBU385; Medline Kit Number/SKU CDS780045O: UDI/DI each 10195327362638, UDI/DI case 40195327362639, Lot Number: 23EBT969; Medline Kit Number/SKU CDS780045O: UDI/DI each 10195327362638, UDI/DI case 40195327362639, Lot Number: 23DBP671; Medline Kit Number/SKU CDS780046O: UDI/DI each 10889942766840, UDI/DI case 40889942766841, Lot Number: 23BBA110; Medline Kit Number/SKU CDS780046O: UDI/DI each 10889942766840, UDI/DI case 40889942766841, Lot Number: 23ABK644; Medline Kit Number/SKU CDS780046O: UDI/DI each 10889942766840, UDI/DI case 40889942766841, Lot Number: 22KBH412; Medline Kit Number/SKU CDS780046O: UDI/DI each 10889942766840, UDI/DI case 40889942766841, Lot Number: 22JBW313; Medline Kit Number/SKU CDS780046O: UDI/DI each 10889942766840, UDI/DI case 40889942766841, Lot Number: 22GBY297; Medline Kit Number/SKU CDS780046O: UDI/DI each 10889942766840, UDI/DI case 40889942766841, Lot Number: 22BBE256; Medline Kit Number/SKU CDS780046O: UDI/DI each 10889942766840, UDI/DI case 40889942766841, Lot Number: 22ABW880; Medline Kit Number/SKU CDS780046O: UDI/DI each 10889942766840, UDI/DI case 40889942766841, Lot Number: 21GBR876; Medline Kit Number/SKU CDS780046O: UDI/DI each 10889942766840, UDI/DI case 40889942766841, Lot Number: 21EBK749; Medline Kit Number/SKU CDS780046O: UDI/DI each 10889942766840, UDI/DI case 40889942766841, Lot Number: 21DBA629; Medline Kit Number/SKU CDS780046O: UDI/DI each 10889942766840, UDI/DI case 40889942766841, Lot Number: 21CBO851; Medline Kit Number/SKU CDS780046O: UDI/DI each 10889942766840, UDI/DI case 40889942766841, Lot Number: 21BBF841; Medline Kit Number/SKU CDS780046O: UDI/DI each 10889942766840, UDI/DI case 40889942766841, Lot Number: 21BBE934; Medline Kit Number/SKU CDS780089AB: UDI/DI each 10198459237294, UDI/DI case 40198459237295, Lot Number: 25JLA079; Medline Kit Number/SKU CDS780089AB: UDI/DI each 10198459237294, UDI/DI case 40198459237295, Lot Number: 25HLA335; Medline Kit Number/SKU CDS780089AB: UDI/DI each 10198459237294, UDI/DI case 40198459237295, Lot Number: 25GLA804; Medline Kit Number/SKU CDS780089AB: UDI/DI each 10198459237294, UDI/DI case 40198459237295, Lot Number: 25GLA017; Medline Kit Number/SKU CDS780089AB: UDI/DI each 10198459237294, UDI/DI case 401984592
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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