Medline medical procedure kits, containing Medline Neuro Sponges (4077 in total), LAMINECTOMY, CRANI, etc. — FDA record Z-2038-2026

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Mar 19, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product
Medline medical procedure kits, containing Medline Neuro Sponges (4077 in total), LAMINECTOMY, CRANI, etc.
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
Recalling firm
Medline Industries, LP
Quantity
1552486 kits
Agency-reported status
Ongoing
Source record identifier
Z-2038-2026

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label fieldDetails supplied by the agency
Lot, code or applicabilityMedline 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 40198459237295, Lot Number: 25CLA001; Medline Kit Number/SKU CDS780089AB: UDI/DI each 10198459237294, UDI/DI case 40198459237295, Lot Number: 25BLA223; Medline Kit Number/SKU CDS780089AB: UDI/DI each 10198459237294, UDI/DI case 40198459237295, Lot Number: 25ALB045; Medline Kit Number/SKU CDS780089AC: UDI/DI each 10198459624636, UDI/DI case 40198459624637, Lot Number: 26BLA097; Medline Kit Number/SKU CDS780089W: UDI/DI each 10193489820881, UDI/DI case 40193489820882, Lot Number: 21ILA871; Medline Kit Number/SKU CDS780089W: UDI/DI each 10193489820881, UDI/DI case 40193489820882, Lot Number: 21ILA014; Medline Kit Number/SKU CDS780089W: UDI/DI each 10193489820881, UDI/DI case 40193489820882, Lot Number: 21ELA714; Medline Kit Number/SKU CDS780089W: UDI/DI each 10193489820881, UDI/DI case 40193489820882, Lot Number: 21ELA499; Medline Kit Number/SKU CDS780089X: UDI/DI each 10195327040437, UDI/DI case 40195327040438, Lot Number: 23JLB027; Medline Kit Number/SKU CDS780089X: UDI/DI each 10195327040437, UDI/DI case 40195327040438, Lot Number: 23JLA704; Medline Kit Number/SKU CDS780089X: UDI/DI each 10195327040437, UDI/DI case 40195327040438, Lot Number: 23JLA126; Medline Kit Number/SKU CDS780089X: UDI/DI each 10195327040437, UDI/DI case 40195327040438, Lot Number: 23ELA364; Medline Kit Number/SKU CDS780089X: UDI/DI each 10195327040437, UDI/DI case 40195327040438, Lot Number: 23CLB179; Medline Kit Number/SKU CDS780089X: UDI/DI each 10195327040437, UDI/DI case 40195327040438, Lot Number: 23BLA523; Medline Kit Number/SKU CDS780089X: UDI/DI each 10195327040437, UDI/DI case 40195327040438, Lot Number: 22KLB074; Medline Kit Number/SKU CDS780089X: UDI/DI each 10195327040437, UDI/DI case 40195327040438, Lot Number: 22ILA257; Medline Kit Number/SKU CDS780089X: UDI/DI each 10195327040437, UDI/DI case 40195327040438, Lot Number: 22GLA532; Medline Kit Number/SKU CDS780089X: UDI/DI each 10195327040437, UDI/DI case 40195327040438, Lot Number: 22FLA045; Medline Kit Number/SKU CDS780089X: UDI/DI each 10195327040437, UDI/DI case 40195327040438, Lot Number: 22DLB117; Medline Kit Number/SKU CDS780089X: UDI/DI each 10195327040437, UDI/DI case 40195327040438, Lot Number: 22BLB011; Medline Kit Number/SKU CDS780089X: UDI/DI each 10195327040437, UDI/DI case 40195327040438, Lot Number: 21LLA962; Medline Kit Number/SKU CDS780089X: UDI/DI each 10195327040437, UDI/DI case 40195327040438, Lot Number: 21LLA794; Medline Kit Number/SKU CDS780089X: UDI/DI each 10195327040437, UDI/DI case 40195327040438, Lot Number: 21LLA724; Medline Kit Number/SKU CDS780089X: UDI/DI each 10195327040437, UDI/DI case 40195327040438, Lot Number: 24BLA505; Medline Kit Number/SKU CDS780089Y: UDI/DI each 10195327642556, UDI/DI case 40195327642557, Lot Number: 24ILA307; Medline Kit Number/SKU CDS780089Y: UDI/DI each 10195327642556, UDI/DI case 40195327642557, Lot Number: 24HLA069; Medline Kit Number/SKU CDS780089Y: UDI/DI each 10195327642556, UDI/DI case 40195327642557, Lot Number: 24FLA573; Medline Kit Number/SKU CDS780089Y: UDI/DI each 10195327642556, UDI/DI case 40195327642557, Lot Number: 24ELA873; Medline Kit Number/SKU CDS780089Y: UDI/DI each 10195327642556, UDI/DI case 40195327642557, Lot Number: 24DLA190; Medline Kit Number/SKU CDS780102K: UDI/DI each 10889942714506, UDI/DI case 40889942714507, Lot Number: 22IBE293; Medline Kit Number/SKU CDS780102K: UDI/DI each 10889942714506, UDI/DI case 40889942714507, Lot Number: 22GBE917; Medline Kit Number/SKU CDS780102M: UDI/DI each 10195327663636, UDI/DI case 40195327663637, Lot Number: 25CBT630; Medline Kit Number/SKU CDS780102N: UDI/DI each 10198459447273, UDI/DI case 40198459447274, Lot Number: 26BBD991; Medline Kit Number/SKU CDS780102N: UDI/DI each 10198459447273, UDI/DI case 40198459447274, Lot Number: 26BBD065; Medline Kit Number/SKU CDS780102N: UDI/DI each 10198459447273, UDI/DI case 40198459447274, Lot Number: 25JBW151; Medline Kit Number/SKU CDS780102N: UDI/DI each 10198459447273, UDI/DI case 40198459447274, Lot Number: 25IBM497; Medline Kit Number/SKU CDS780105L: UDI/DI each 10195327051877, UDI/DI case 40195327051878, Lot Number: 23JBL140; Medline Kit Number/SKU CDS780105L: UDI/DI each 10195327051877, UDI/DI case 40195327051878, Lot Number: 23FBA008; Medline Kit Number/SKU CDS780105L: UDI/DI each 10195327051877, UDI/DI case 40195327051878, Lot Number: 23FBA141; Medline Kit Number/SKU CDS780105L: UDI/DI each 10195327051877, UDI/DI case 40195327051878, Lot Number: 23DBD675; Medline Kit Number/SKU CDS780105L: UDI/DI each 10195327051877, UDI/DI case 40195327051878, Lot Number: 23ABD934; Medline Kit Number/SKU CDS780105L: UDI/DI each 10195327051877, UDI/DI case 40195327051878, Lot Number: 23ABE600; Medline Kit Number/SKU CDS780105L: UDI/DI each 10195327051877, UDI/DI case 40195327051878, Lot Number: 22IBA597; Medline Kit Number/SKU CDS780105L: UDI/DI each 10195327051877, UDI/DI case 40195327051878, Lot Number: 22HBI798; Medline Kit Number/SKU CDS780105L: UDI/DI each 10195327051877, UDI/DI case 40195327051878, Lot Number: 22GBA843; Medline Kit Number/SKU CDS780105L: UDI/DI each 10195327051877, UDI/DI case 40195327051878, Lot Number: 22FBW180; Medline Kit Number/SKU CDS780105L: UDI/DI each 10195327051877, UDI/DI case 40195327051878, Lot Number: 22EBE861; Medline Kit Number/SKU CDS780105L: UDI/DI each 10195327051877, UDI/DI case 40195327051878, Lot Number: 23LBQ382; Medline Kit Number/SKU CDS780105M: UDI/DI each 10195327663407, UDI/DI case 40195327663408, Lot Number: 25FBP497; Medline Kit Number/SKU CDS780105M: UDI/DI each 10195327663407, UDI/DI case 40195327663408, Lot Number: 25EBV055; Medline Kit Number/SKU CDS780105M: UDI/DI each 10195327663407, UDI/DI case 40195327663408, Lot Number: 25EBL317; Medline Kit Number/SKU CDS780105M: UDI/DI each 10195327663407, UDI/DI case 40195327663408, Lot Number: 25DBE917; Medline Kit Number/SKU CDS780105M: UDI/DI each 10195327663407, UDI/DI case 40195327663408, Lot Number: 24JBK737; Medline Kit Number/SKU CDS780105M: UDI/DI each 10195327663407, UDI/DI case 40195327663408, Lot Number: 24IBS790; Medline Kit Number/SKU CDS780105M: UDI/DI each 10195327663407, UDI/DI case 40195327663408, Lot Number: 24HBW126; Medline Kit Number/SKU CDS780105M: UDI/DI each 10195327663407, UDI/DI case 40195327663408, Lot Number: 24HBU251; Medline Kit Number/SKU CDS780105M: UDI/DI each 10195327663407, UDI/DI case 40195327663408, Lot Number: 24HBP053; Medline Kit Number/SKU CDS780105M: UDI/DI each 10195327663407, UDI/DI case 40195327663408, Lot Number: 24GBB610; Medline Kit Number/SKU CDS780105M: UDI/DI each 10195327663407, UDI/DI case 40195327663408, Lot Number: 24DBO904; Medline Kit Number/SKU CDS780105M: UDI/DI each 10195327663407, UDI/DI case 40195327663408, Lot Number: 24DBD154; Medline Kit Number/SKU CDS780105N: UDI/DI each 10198459447280, UDI/DI case 40198459447281, Lot Number: 25JBN912; Medline Kit Number/SKU CDS780105N: UDI/DI each 10198459447280, UDI/DI case 40198459447281, Lot Number: 25IBT692; Medline Kit Number/SKU CDS780105P: UDI/DI each 10198459593314, UDI/DI case 40198459593315, Lot Number: 25LBR123; Medline Kit Number/SKU CDS780109P: UDI/DI each 10195327534400, UDI/DI case 40195327534401, Lot Number: 23KBM336; Medline Kit Number/SKU CDS780109P: UDI/DI each 10195327534400, UDI/DI case 40195327534401, Lot Number: 24GBY614; Medline Kit Number/SKU CDS780109P: UDI/DI each 10195327534400, UDI/DI case 40195327534401, Lot Number: 24GBE982; Medline Kit Number/SKU CDS780109P: UDI/DI each 10195327534400, UDI/DI case 40195327534401, Lot Number: 24FBK737; Medline Kit Number/SKU CDS780109P: UDI/DI each 10195327534400, UDI/DI case 40195327534401, Lot Number: 24BBS869; Medline Kit Number/SKU CDS780109P: UDI/DI each 10195327534400, UDI/DI case 40195327534401, Lot Number: 24ABL060; Medline Kit Number/SKU CDS780109R: UDI/DI each 10198459286339, UDI/DI case 40198459286330, Lot Number: 25KBD574; Medline Kit Number/SKU CDS780109R: UDI/DI each 10198459286339, UDI/DI case 40198459286330, Lot Number: 25IBW109; Medline Kit Number/SKU CDS780109R: UDI/DI each 10198459286339, UDI/DI case 40198459286330, Lot Number: 25HBJ736; Medline Kit...

The agency lot list is longer than this excerpt. Read the complete list at the official source.

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

Worldwide distribution.

No US distribution state could be established from this record. Check the official notice.

Dates in the source

Report date
May 6, 2026
Recall initiation date
Mar 19, 2026
Center classification date
Apr 30, 2026

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

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