Recall archive / FDA device enforcement
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
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 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.