Medline medical procedure kits, containing Medline Neuro Sponges (4077 in total), LAMINECTOMY, CRANI, etc.
Summary
The FDA issued a Class II for Medline medical procedure kits, containing Medline Neuro Sponges (4077 in total) by Medline Industries, LP. Reason: During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that .
Details
Source
Device Recall
External ID
Z-2038-2026
Action Date
2026-05-06
Status
Ongoing
Category
device
Product Description
Medline medical procedure kits, containing Medline Neuro Sponges (4077 in total), LAMINECTOMY, CRANI, etc.
Lot/Code Info: 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 Number/SKU CDS780109R: UDI/DI each 10198459286339, UDI/DI case 40198459286330, Lot Number: 25FBW129; Medline Kit Number/SKU CDS780109R: UDI/DI each 10198459286339, UDI/DI case 40198459286330, Lot Number: 25EBK645; Medline Kit Number/SKU CDS780109R: UDI/DI each 10198459286339, UDI/DI case 40198459286330, Lot Number: 25DBH512; Medline Kit Number/SKU CDS780109R: UDI/DI each 10198459286339, UDI/DI case 40198459286330, Lot Number: 25DBB522; Medline Kit Number/SKU CDS780109S: UDI/DI each 10198459635885, UDI/DI case 40198459635886, Lot Number: 26CBD985; Medline Kit Number/SKU CDS780109S: UDI/DI each 10198459635885, UDI/DI case 40198459635886, Lot Number: 26ABR295; Medline Kit Number/SKU CDS780109S: UDI/DI each 10198459635885, UDI/DI case 40198459635886, Lot Number: 26ABN926; Medline Kit Number/SKU CDS780111N: UDI/DI each 10193489332520, UDI/DI case 40193489332521, Lot Number: 21HBS235; Medline Kit Number/SKU CDS780111N: UDI/DI each 10193489332520, UDI/DI case 40193489332521, Lot Number: 21HBS239; Medline Kit Number/SKU CDS780111O: UDI/DI each 10195327065263, UDI/DI case 40195327065264, Lot Number: 23JBP367; Medline Kit Number/SKU CDS780111O: UDI/DI each 10195327065263, UDI/DI case 40195327065264, Lot Number: 23IBK502; Medline Kit Number/SKU CDS780111O: UDI/DI each 10195327065263, UDI/DI case 40195327065264, Lot Number: 23BBT628; Medline Kit Number/SKU CDS780111O: UDI/DI each 10195327065263, UDI/DI case 40195327065264, Lot Number: 23ABR378; Medline Kit Number/SKU CDS780111O: UDI/DI each 10195327065263, UDI/DI case 40195327065264, Lot Number: 22KBD815; Medline Kit Number/SKU CDS780111O: UDI/DI each 10195327065263, UDI/DI case 40195327065264, Lot Number: 22FBY057; Medline Kit Number/SKU CDS780111O: UDI/DI each 10195327065263, UDI/DI case 40195327065264, Lot Number: 22DBP856; Medline Kit Number/SKU CDS780111O: UDI/DI each 10195327065263, UDI/DI case 40195327065264, Lot Number: 22OBD871; Medline Kit Number/SKU CDS780111O: UDI/DI each 10195327065263, UDI/DI case 40195327065264, Lot Number: 22BBS177; Medline Kit Number/SKU CDS780111P: UDI/DI each 10195327534387, UDI/DI case 40195327534388, Lot Number: 24HBF870; Medline Kit Number/SKU CDS780111P: UDI/DI each 10195327534387, UDI/DI case 40195327534388, Lot Number: 24FBT035; Medline Kit Number/SKU CDS780111P: UDI/DI each 10195327534387, UDI/DI case 40195327534388, Lot Number: 24FBE686; Medline Kit Number/SKU CDS780111P: UDI/DI each 10195327534387, UDI/DI case 40195327534388, Lot Number: 24FBA005; Medline Kit Number/SKU CDS780111P: UDI/DI each 10195327534387, UDI/DI case 40195327534388, Lot Number: 24DBM857; Medline Kit Number/SKU CDS780111P: UDI/DI each 10195327534387, UDI/DI case 40195327534388, Lot Number: 24DBM742; Medline Kit Number/SKU CDS780111P: UDI/DI each 10195327534387, UDI/DI case 40195327534388, Lot Number: 24BBK181; Medline Kit Number/SKU CDS780111P: UDI/DI each 10195327534387, UDI/DI case 40195327534388, Lot Number: 24ABL026; Medline Kit Number/SKU CDS780111R: UDI/DI each 10198459286278, UDI/DI case 40198459286279, Lot Number: 25KBG164; Medline Kit Number/SKU CDS780111R: UDI/DI each 10198459286278, UDI/DI case 40198459286279, Lot Number: 25JBN943; Medline Kit Number/SKU CDS780111R: UDI/DI each 10198459286278, UDI/DI case 40198459286279, Lot Number: 25IBC262; Medline Kit Number/SKU CDS780111R: UDI/DI each 10198459286278, UDI/DI case 40198459286279, Lot Number: 25GBT325; Medline Kit Number/SKU CDS780111R: UDI/DI each 10198459286278, UDI/DI case 40198459286279, Lot Number: 25GBI531; Medline Kit Number/SKU CDS780111R: UDI/DI each 10198459286278, UDI/DI case 40198459286279, Lot Number: 25EBE118; Medline Kit Number/SKU CDS780111R: UDI/DI each 10198459286278, UDI/DI case 40198459286279, Lot Number: 25CBM989; Medline Kit Number/SKU CDS780112I: UDI/DI each 10193489332902, UDI/DI case 40193489332903, Lot Number: 21DBL012; Medline Kit Number/SKU CDS780112I: UDI/DI each 10193489332902, UDI/DI case 40193489332903, Lot Number: 21DBI940; Medline Kit Number/SKU CDS780112J: UDI/DI each 10195327009663, UDI/DI case 40195327009664, Lot Number: 23FBO500; Medline Kit Number/SKU CDS780112J: UDI/DI each 10195327009663, UDI/DI case 40195327009664, Lot Number: 23CBH389; Medline Kit Number/SKU CDS780112J: UDI/DI each 10195327009663, UDI/DI case 40195327009664, Lot Number: 22HBT278; Medline Kit Number/SKU CDS780112J: UDI/DI each 10195327009663, UDI/DI case 40195327009664, Lot Number: 22FBF455; Medline Kit Number/SKU CDS780112J: UDI/DI each 10195327009663, UDI/DI case 40195327009664, Lot Number: 22ABV564; Medline Kit Number/SKU CDS780112J: UDI/DI each 10195327009663, UDI/DI case 40195327009664, Lot Number: 21KBT463; Medline Kit Number/SKU CDS780119V: UDI/DI each 10195327114916, UDI/DI case 40195327114917, Lot Number: 23JBS979; Medline Kit Number/SKU CDS780119V: UDI/DI each 10195327114916, UDI/DI case 40195327114917, Lot Number: 23GBQ904; Medline Kit Number/SKU CDS780119V: UDI/DI each 10195327114916, UDI/DI case 40195327114917, Lot Number: 23DBE182; Medline Kit Number/SKU CDS780119V: UDI/DI each 10195327114916, UDI/DI case 40195327114917, Lot Number: 23BBQ326; Medline Kit Number/SKU CDS780119V: UDI/DI each 10195327114916, UDI/DI case 40195327114917, Lot Number: 23ABF941; Medline Kit Number/SKU CDS780119V: UDI/DI each 10195327114916, UDI/DI case 40195327114917, Lot Number: 24IBL177; Medline Kit Number/SKU CDS780119V: UDI/DI each 10195327114916, UDI/DI case 40195327114917, Lot Number: 24IBB227; Medline Kit Number/SKU CDS780119V: UDI/DI each 10195327114916, UDI/DI case 40195327114917, Lot Number: 24HBW819; Medline Kit Number/SKU CDS780119V: UDI/DI each 10195327114916, UDI/DI case 40195327114917, Lot Number: 24HBQ511; Medline Kit Number/SKU CDS780119V: UDI/DI each 10195327114916, UDI/DI case 40195327114917, Lot Number: 24GBU268; Medline Kit Number/SKU CDS780119V: UDI/DI each 10195327114916, UDI/DI case 40195327114917, Lot Number: 24FBK934; Medline Kit Number/SKU CDS780119V: UDI/DI each 10195327114916, UDI/DI case 40195327114917, Lot Number: 24DBR263; Medline Kit Number/SKU CDS780119V: UDI/DI each 10195327114916, UDI/DI case 40195327114917, Lot Number: 24CBN697; Medline Kit Number/SKU CDS780119V: UDI/DI each 10195327114916, UDI/DI case 40195327114917, Lot Number: 24BBK027; Medline Kit Number/SKU CDS780119V: UDI/DI each 10195327114916, UDI/DI case 40195327114917, Lot Number: 24ABF767; Medline Kit Number/SKU CDS780119V: UDI/DI each 10195327114916, UDI/DI case 40195327114917, Lot Number: 23LBD741; Medline Kit Number/SKU CDS780165L: UDI/DI each 10889942538317, UDI/DI case 40889942538318, Lot Number: 21EBC434; Medline Kit Number/SKU CDS780165L: UDI/DI each 10889942538317, UDI/DI case 40889942538318, Lot Number: 21CBE173; Medline Kit Number/SKU CDS780165M: UDI/DI each 10193489903959, UDI/DI case 40193489903950, Lot Number: 21IBL038; Medline Kit Number/SKU CDS780165M: UDI/DI each 10193489903959, UDI/DI case 40193489903950, Lot Number: 21GBV745; Medline Kit Number/SKU CDS780165N: UDI/DI each 10195327020019, UDI/DI case 40195327020010, Lot Number: 22LBL139; Medline Kit Number/SKU CDS780165N: UDI/DI each 10195327020019, UDI/DI case 40195327020010, Lot Number: 22KBE478; Medline Kit Number/SKU CDS780165N: UDI/DI each 10195327020019, UDI/DI case 40195327020010, Lot Number: 22JBJ077; Medline Kit Number/SKU CDS780165N: UDI/DI each 10195327020019, UDI/DI case 40195327020010, Lot Number: 22IBS658; Medline Kit Number/SKU CDS780165N: UDI/DI each 10195327020019, UDI/DI case 40195327020010, Lot Number: 22IBS659; Medline Kit Number/SKU CDS780165N: UDI/DI each 10195327020019, UDI/DI case 40195327020010, Lot Number: 22GBW164; Medline Kit Number/SKU CDS780165N: UDI/DI each 10195327020019, UDI/DI case 40195327020010, Lot Number: 22FBG624; Medline Kit Number/SKU CDS780165N: UDI/DI each 10195327020019, UDI/DI case 40195327020010, Lot Number: 22FBG637; Medline Kit Number/SKU CDS780165N: UDI/DI each 10195327020019, UDI/DI case 40195327020010, Lot Number: 22DBS060; Medline Kit Number/SKU CDS780165N: UDI/DI each 10195327020019, UDI/DI case 40195327020010, Lot Number: 22BBX965; Medline Kit Number/SKU CDS780165N: UDI/DI each 10195327020019, UDI/DI case 40195327020010, Lot Number: 22BBX966; Medline Kit Number/SKU CDS780165N: UDI/DI each 10195327020019, UDI/DI case 40195327020010, Lot Number: 21LBH639; Medline Kit Number/SKU CDS780165O: UDI/DI each 10195327323042, UDI/DI case 40195327323043, Lot Number: 23FBG448; Medline Kit Number/SKU CDS780165O: UDI/DI each 10195327323042, UDI/DI case 40195327323043, Lot Number: 23CBU486; Medline Kit Number/SKU CDS780165O: UDI/DI each 10195327323042, UDI/DI case 40195327323043, Lot Number: 23BBD144; Medline Kit Number/SKU CDS780165Q: UDI/DI each 10195327455545, UDI/DI case 40195327455546, Lot Number: 23JBR705; Medline Kit Number/SKU CDS780165Q: UDI/DI each 10195327455545, UDI/DI case 40195327455546, Lot Number: 23IBG822; Medline Kit Number/SKU CDS780165Q: UDI/DI each 10195327455545, UDI/DI case 40195327455546, Lot Number: 23IBD830; Medline Kit Number/SKU CDS780165R: UDI/DI each 10195327557560, UDI/DI case 40195327557561, Lot Number: 24CBO277; Medline Kit Number/SKU CDS780165R: UDI/DI each 10195327557560, UDI/DI case 40195327557561, Lot Number: 24ABD703; Medline Kit Number/SKU CDS780165S: UDI/DI each 10198459004704, UDI/DI case 40198459004705, Lot Number: 24LBT634; Medline Kit Number/SKU CDS780165S: UDI/DI each 10198459004704, UDI/DI case 40198459004705, Lot Number: 24KBO341; Medline Kit Number/SKU CDS780165S: UDI/DI each 10198459004704, UDI/DI case 40198459004705, Lot Number: 24JBQ512; Medline Kit Number/SKU CDS780165S: UDI/DI each 10198459004704, UDI/DI case 40198459004705, Lot Number: 24JBI641; Medline Kit Number/SKU CDS780165S: UDI/DI each 10198459004704, UDI/DI case 40198459004705, Lot Number: 24IBK951; Medline Kit Number/SKU CDS780165S: UDI/DI each 10198459004704, UDI/DI case 40198459004705, Lot Number: 24HBM605; Medline Kit Number/SKU CDS780165S: UDI/DI each 10198459004704, UDI/DI case 40198459004705, Lot Number: 24GBU280; Medline Kit Number/SKU CDS780165S: UDI/DI each 10198459004704, UDI/DI case 40198459004705, Lot Number: 24FBK150; Medline Kit Number/SKU CDS780165S: UDI/DI each 10198459004704, UDI/DI case 40198459004705, Lot Number: 24FBE306; Medline Kit Number/SKU CDS780165T: UDI/DI each 10198459245138, UDI/DI case 40198459245139, Lot Number: 25EBS236; Medline Kit Number/SKU CDS780165T: UDI/DI each 10198459245138, UDI/DI case 40198459245139, Lot Number: 25EBH579; Medline Kit Number/SKU CDS780165T: UDI/DI each 10198459245138, UDI/DI case 40198459245139, Lot Number: 25EBF564; Medline Kit Number/SKU CDS780165T: UDI/DI each 10198459245138, UDI/DI case 40198459245139, Lot Number: 25CBT486; Medline Kit Number/SKU CDS780165T: UDI/DI each 10198459245138, UDI/DI case 40198459245139, Lot Number: 25BBO757; Medline Kit Number/SKU CDS780165U: UDI/DI each 10198459370977, UDI/DI case 40198459370978, Lot Number: 26BBK943; Medline Kit Number/SKU CDS780165U: UDI/DI each 10198459370977, UDI/DI case 40198459370978, Lot Number: 26ABP036; Medline Kit Number/SKU CDS780165U: UDI/DI each 10198459370977, UDI/DI case 40198459370978, Lot Number: 25LBJ862; Medline Kit Number/SKU CDS780165U: UDI/DI each 10198459370977, UDI/DI case 40198459370978, Lot Number: 25LBA195; Medline Kit Number/SKU CDS780165U: UDI/DI each 10198459370977, UDI/DI case 40198459370978, Lot Number: 25JBT359; Medline Kit Number/SKU CDS780165U: UDI/DI each 10198459370977, UDI/DI case 40198459370978, Lot Number: 25HBM927; Medline Kit Number/SKU CDS780165U: UDI/DI each 10198459370977, UDI/DI case 40198459370978, Lot Number: 25HBA123; Medline Kit Number/SKU CDS780165U: UDI/DI each 10198459370977, UDI/DI case 40198459370978, Lot Number: 25FBU521; Medline Kit Number/SKU CDS780166Q: UDI/DI each 10889942611737, UDI/DI case 40889942611738, Lot Number: 21IBT365; Medline Kit Number/SKU CDS780166Q: UDI/DI each 10889942611737, UDI/DI case 40889942611738, Lot Number: 21IBO592; Medline Kit Number/SKU CDS780166Q: UDI/DI each 10889942611737, UDI/DI case 40889942611738, Lot Number: 21HBA493; Medline Kit Number/SKU CDS780166Q: UDI/DI each 10889942611737, UDI/DI case 40889942611738, Lot Number: 21EBK801; Medline Kit Number/SKU CDS780166Q: UDI/DI each 10889942611737, UDI/DI case 40889942611738, Lot Number: 21BBM815; Medline Kit Number/SKU CDS780166R: UDI/DI each 10195327020026, UDI/DI case 40195327020027, Lot Number: 22IBB675; Medline Kit Number/SKU CDS780166R: UDI/DI each 10195327020026, UDI/DI case 40195327020027, Lot Number: 22GBD876; Medline Kit Number/SKU CDS780166R: UDI/DI each 10195327020026, UDI/DI case 40195327020027, Lot Number: 22EBN087; Medline Kit Number/SKU CDS780166R: UDI/DI each 10195327020026, UDI/DI case 40195327020027, Lot Number: 22DBI993; Medline Kit Number/SKU CDS780166R: UDI/DI each 10195327020026, UDI/DI case 40195327020027, Lot Number: 22BBU293; Medline Kit Number/SKU CDS780166R: UDI/DI each 10195327020026, UDI/DI case 40195327020027, Lot Number: 22ABY326; Medline Kit Number/SKU CDS780166S: UDI/DI each 10195327228774, UDI/DI case 40195327228775, Lot Number: 23ABM884; Medline Kit Number/SKU CDS780166T: UDI/DI each 10195327323011, UDI/DI case 40195327323012, Lot Number: 23DBT180; Medline Kit Number/SKU CDS780166T: UDI/DI each 10195327323011, UDI/DI case 40195327323012, Lot Number: 23BBB002; Medline Kit Number/SKU CDS780166U: UDI/DI each 10195327407179, UDI/DI case 40195327407170, Lot Number: 23IBG519; Medline Kit Number/SKU CDS780166V: UDI/DI each 10195327557539, UDI/DI case 40195327557530, Lot Number: 24DBM976; Medline Kit Number/SKU CDS780166V: UDI/DI each 10195327557539, UDI/DI case 40195327557530, Lot Number: 24BBI311; Medline Kit Number/SKU CDS780166V: UDI/DI each 10195327557539, UDI/DI case 40195327557530, Lot Number: 24ABB703; Medline Kit Number/SKU CDS780166W: UDI/DI each 10198459004711, UDI/DI case 40198459004712, Lot Number: 25ABL260; Medline Kit Number/SKU CDS780166W: UDI/DI each 10198459004711, UDI/DI case 40198459004712, Lot Number: 24JBR668; Medline Kit Number/SKU CDS780166W: UDI/DI each 10198459004711, UDI/DI case 40198459004712, Lot Number: 24HBG985; Medline Kit Number/SKU CDS780166W: UDI/DI each 10198459004711, UDI/DI case 40198459004712, Lot Number: 24GBF437; Medline Kit Number/SKU CDS780166X: UDI/DI each 10198459245053, UDI/DI case 40198459245054, Lot Number: 26ABK190; Medline Kit Number/SKU CDS780166X: UDI/DI each 10198459245053, UDI/DI case 40198459245054, Lot Number: 26ABE660; Medline Kit Number/SKU CDS780166X: UDI/DI each 10198459245053, UDI/DI case 40198459245054, Lot Number: 25IBT854; Medline Kit Number/SKU CDS780166X: UDI/DI each 10198459245053, UDI/DI case 40198459245054, Lot Number: 25HBS092; Medline Kit Number/SKU CDS780166X: UDI/DI each 10198459245053, UDI/DI case 40198459245054, Lot Number: 25HBC543; Medline Kit Number/SKU CDS780166X: UDI/DI each 10198459245053, UDI/DI case 40198459245054, Lot Number: 25GBD190; Medline Kit Number/SKU CDS780166X: UDI/DI each 10198459245053, UDI/DI case 40198459245054, Lot Number: 25EBV571; Medline Kit Number/SKU CDS780166X: UDI/DI each 10198459245053, UDI/DI case 40198459245054, Lot Number: 25BBG379; Medline Kit Number/SKU CDS780166X: UDI/DI each 10198459245053, UDI/DI case 40198459245054, Lot Number: 25BBD013; Medline Kit Number/SKU CDS780204Q: UDI/DI each 10193489354829, UDI/DI case 40193489354820, Lot Number: 23GMI785; Medline Kit Number/SKU CDS780204Q: UDI/DI each 10193489354829, UDI/DI case 40193489354820, Lot Number: 23GMC779; Medline Kit Number/SKU CDS780204Q: UDI/DI each 10193489354829, UDI/DI case 40193489354820, Lot Number: 23DMH775; Medline Kit Number/SKU CDS780204Q: UDI/DI each 10193489354829, UDI/DI case 40193489354820, Lot Number: 22KMG319; Medline Kit Number/SKU CDS780204Q: UDI/DI each 10193489354829, UDI/DI case 40193489354820, Lot Number: 22JMG642; Medline Kit Number/SKU CDS780204Q: UDI/DI each 10193489354829, UDI/DI case 40193489354820, Lot Number: 21LMG913; Medline Kit Number/SKU CDS780204Q: UDI/DI each 10193489354829, UDI/DI case 40193489354820, Lot Number: 21JMI331; Medline Kit Number/SKU CDS780204Q: UDI/DI each 10193489354829, UDI/DI case 40193489354820, Lot Number: 21JMF852; Medline Kit Number/SKU CDS780204Q: UDI/DI each 10193489354829, UDI/DI case 40193489354820, Lot Number: 21JMB144; Medline Kit Number/SKU CDS780204Q: UDI/DI each 10193489354829, UDI/DI case 40193489354820, Lot Number: 21IMB714; Medline Kit Number/SKU CDS780204Q: UDI/DI each 10193489354829, UDI/DI case 40193489354820, Lot Number: 21GMA434; Medline Kit Number/SKU CDS780204Q: UDI/DI each 10193489354829, UDI/DI case 40193489354820, Lot Number: 21FMD248; Medline Kit Number/SKU CDS780204Q: UDI/DI each 10193489354829, UDI/DI case 40193489354820, Lot Number: 21DMD320; Medline Kit Number/SKU CDS780204Q: UDI/DI each 10193489354829, UDI/DI case 40193489354820, Lot Number: 21AKB175; Medline Kit Number/SKU CDS780204Q: UDI/DI each 10193489354829, UDI/DI case 40193489354820, Lot Number: 25EMH929; Medline Kit Number/SKU CDS780204Q: UDI/DI each 10193489354829, UDI/DI case 40193489354820, Lot Number: 25EME829; Medline Kit Number/SKU CDS780204Q: UDI/DI each 10193489354829, UDI/DI case 40193489354820, Lot Number: 25CMJ168; Medline Kit Number/SKU CDS780204Q: UDI/DI each 10193489354829, UDI/DI case 40193489354820, Lot Number: 25CMD634; Medline Kit Number/SKU CDS780204Q: UDI/DI each 10193489354829, UDI/DI case 40193489354820, Lot Number: 24KMJ366; Medline Kit Number/SKU CDS780204Q: UDI/DI each 10193489354829, UDI/DI case 40193489354820, Lot Number: 24DMF897; Medline Kit Number/SKU CDS780204Q: UDI/DI each 10193489354829, UDI/DI case 40193489354820, Lot Number: 24CMH366; Medline Kit Number/SKU CDS780205Q: UDI/DI each 10193489354836, UDI/DI case 40193489354837, Lot Number: 25AMG476; Medline Kit Number/SKU CDS780205R: UDI/DI each 10198459430732, UDI/DI case 40198459430733, Lot Number: 25HMJ405; Medline Kit Number/SKU CDS780205S: UDI/DI each 10198459524899, UDI/DI case 40198459524890, Lot Number: 25JMC241; Medline Kit Number/SKU CDS780206R: UDI/DI each 10193489355314, UDI/DI case 40193489355315, Lot Number: 24LMA952; Medline Kit Number/SKU CDS780206T: UDI/DI each 10198459524905, UDI/DI case 40198459524906, Lot Number: 25JMC242; Medline Kit Number/SKU CDS780208I: UDI/DI each 10195327525231, UDI/DI case 40195327525232, Lot Number: 23JBU709; Medline Kit Number/SKU CDS780208I: UDI/DI each 10195327525231, UDI/DI case 40195327525232, Lot Number: 26BBI646; Medline Kit Number/SKU CDS780208I: UDI/DI each 10195327525231, UDI/DI case 40195327525232, Lot Number: 25LBT484; Medline Kit Number/SKU CDS780208I: UDI/DI each 10195327525231, UDI/DI case 40195327525232, Lot Number: 25JBP632; Medline Kit Number/SKU CDS780208I: UDI/DI each 10195327525231, UDI/DI case 40195327525232, Lot Number: 25IBI998; Medline Kit Number/SKU CDS780208I: UDI/DI each 10195327525231, UDI/DI case 40195327525232, Lot Number: 25IBB503; Medline Kit Number/SKU CDS780208I: UDI/DI each 10195327525231, UDI/DI case 40195327525232, Lot Number: 25HBJ407; Medline Kit Number/SKU CDS780208I: UDI/DI each 10195327525231, UDI/DI case 40195327525232, Lot Number: 25FBS862; Medline Kit Number/SKU CDS780208I: UDI/DI each 10195327525231, UDI/DI case 40195327525232, Lot Number: 25DBL474; Medline Kit Number/SKU CDS780208I: UDI/DI each 10195327525231, UDI/DI case 40195327525232, Lot Number: 25CBT710; Medline Kit Number/SKU CDS780208I: UDI/DI each 10195327525231, UDI/DI case 40195327525232, Lot Number: 25ABL276; Medline Kit Number/SKU CDS780208I: UDI/DI each 10195327525231, UDI/DI case 40195327525232, Lot Number: 24LBS031; Medline Kit Number/SKU CDS780208I: UDI/DI each 10195327525231, UDI/DI case 40195327525232, Lot Number: 24LBS233; Medline Kit Number/SKU CDS780208I: UDI/DI each 10195327525231, UDI/DI case 40195327525232, Lot Number: 24JBB183; Medline Kit Number/SKU CDS780208I: UDI/DI each 10195327525231, UDI/DI case 40195327525232, Lot Number: 24IBB855; Medline Kit Number/SKU CDS780208I: UDI/DI each 10195327525231, UDI/DI case 40195327525232, Lot Number: 24HBN544; Medline Kit Number/SKU CDS780208I: UDI/DI each 10195327525231, UDI/DI case 40195327525232, Lot Number: 24DBS375; Medline Kit Number/SKU CDS780208I: UDI/DI each
Quantity Affected: 1552486 kits
Reason for Recall
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.
Distribution
Worldwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-03-19
Company
Northfield, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 275 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Medline Industries, LP has 442 FDA actions in our database, including 415 recalls and 27 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medline Industries, LP) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medline Industries, LP have FDA actions?
Medline Industries, LP has 442 FDA actions in our database, including 415 recalls and 27 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2038-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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