Medline medical procedure kits, containing Medline Neuro Sponges (102 in total)
Summary
The FDA issued a Class II for Medline medical procedure kits, containing Medline Neuro Sponges (102 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-2025-2026
Action Date
2026-05-06
Status
Ongoing
Category
device
Product Description
Medline medical procedure kits, containing Medline Neuro Sponges (102 in total)
Lot/Code Info: Medline Kit Number/SKU CDS980375L: UDI/DI each 10193489922882, UDI/DI case 40193489922883, Lot Number: 23KBN711; Medline Kit Number/SKU CDS980375L: UDI/DI each 10193489922882, UDI/DI case 40193489922883, Lot Number: 23GBD593; Medline Kit Number/SKU CDS980375L: UDI/DI each 10193489922882, UDI/DI case 40193489922883, Lot Number: 23GBD781; Medline Kit Number/SKU CDS980375L: UDI/DI each 10193489922882, UDI/DI case 40193489922883, Lot Number: 23DBF906; Medline Kit Number/SKU CDS980375L: UDI/DI each 10193489922882, UDI/DI case 40193489922883, Lot Number: 22LBI985; Medline Kit Number/SKU CDS980375L: UDI/DI each 10193489922882, UDI/DI case 40193489922883, Lot Number: 22KBC504; Medline Kit Number/SKU CDS980375L: UDI/DI each 10193489922882, UDI/DI case 40193489922883, Lot Number: 22IBF741; Medline Kit Number/SKU CDS980375L: UDI/DI each 10193489922882, UDI/DI case 40193489922883, Lot Number: 22FBX069; Medline Kit Number/SKU CDS980375L: UDI/DI each 10193489922882, UDI/DI case 40193489922883, Lot Number: 22DBS948; Medline Kit Number/SKU CDS980375L: UDI/DI each 10193489922882, UDI/DI case 40193489922883, Lot Number: 22CBX667; Medline Kit Number/SKU CDS980375L: UDI/DI each 10193489922882, UDI/DI case 40193489922883, Lot Number: 21IBT137; Medline Kit Number/SKU CDS980375L: UDI/DI each 10193489922882, UDI/DI case 40193489922883, Lot Number: 21HBG608; Medline Kit Number/SKU CDS980375L: UDI/DI each 10193489922882, UDI/DI case 40193489922883, Lot Number: 25GBV215; Medline Kit Number/SKU CDS980375L: UDI/DI each 10193489922882, UDI/DI case 40193489922883, Lot Number: 25GBA852; Medline Kit Number/SKU CDS980375L: UDI/DI each 10193489922882, UDI/DI case 40193489922883, Lot Number: 24KBJ988; Medline Kit Number/SKU CDS980375L: UDI/DI each 10193489922882, UDI/DI case 40193489922883, Lot Number: 24JBC528; Medline Kit Number/SKU CDS980375L: UDI/DI each 10193489922882, UDI/DI case 40193489922883, Lot Number: 24IBV131; Medline Kit Number/SKU CDS980375L: UDI/DI each 10193489922882, UDI/DI case 40193489922883, Lot Number: 24IBP386; Medline Kit Number/SKU CDS980375L: UDI/DI each 10193489922882, UDI/DI case 40193489922883, Lot Number: 24GBA976; Medline Kit Number/SKU CDS980375L: UDI/DI each 10193489922882, UDI/DI case 40193489922883, Lot Number: 24CBU492; Medline Kit Number/SKU CDS980375L: UDI/DI each 10193489922882, UDI/DI case 40193489922883, Lot Number: 23KBW165; Medline Kit Number/SKU CDS980375M: UDI/DI each 10198459447327, UDI/DI case 40198459447328, Lot Number: 26ABK337; Medline Kit Number/SKU CDS980375M: UDI/DI each 10198459447327, UDI/DI case 40198459447328, Lot Number: 25JBE079; Medline Kit Number/SKU CDS980375M: UDI/DI each 10198459447327, UDI/DI case 40198459447328, Lot Number: 25HBV443; Medline Kit Number/SKU CDS982939U: UDI/DI each 10198459333330, UDI/DI case 40198459333331, Lot Number: 25IBR604; Medline Kit Number/SKU CDS982939U: UDI/DI each 10198459333330, UDI/DI case 40198459333331, Lot Number: 25HBR025; Medline Kit Number/SKU CDS982939U: UDI/DI each 10198459333330, UDI/DI case 40198459333331, Lot Number: 25GBB389; Medline Kit Number/SKU CDS982939U: UDI/DI each 10198459333330, UDI/DI case 40198459333331, Lot Number: 25FBC324; Medline Kit Number/SKU CDS983100D: UDI/DI each 10198459007934, UDI/DI case 40198459007935, Lot Number: 24KBH657; Medline Kit Number/SKU CDS983100D: UDI/DI each 10198459007934, UDI/DI case 40198459007935, Lot Number: 24GBN523; Medline Kit Number/SKU CDS983173I: UDI/DI each 10195327170981, UDI/DI case 40195327170982, Lot Number: 23IBT936; Medline Kit Number/SKU CDS983173I: UDI/DI each 10195327170981, UDI/DI case 40195327170982, Lot Number: 23HBA798; Medline Kit Number/SKU CDS983173I: UDI/DI each 10195327170981, UDI/DI case 40195327170982, Lot Number: 23FBF767; Medline Kit Number/SKU CDS983173I: UDI/DI each 10195327170981, UDI/DI case 40195327170982, Lot Number: 23DBD282; Medline Kit Number/SKU CDS983173I: UDI/DI each 10195327170981, UDI/DI case 40195327170982, Lot Number: 22KBJ790; Medline Kit Number/SKU CDS983173I: UDI/DI each 10195327170981, UDI/DI case 40195327170982, Lot Number: 22HBD313; Medline Kit Number/SKU CDS983173I: UDI/DI each 10195327170981, UDI/DI case 40195327170982, Lot Number: 24DBC806; Medline Kit Number/SKU CDS983173I: UDI/DI each 10195327170981, UDI/DI case 40195327170982, Lot Number: 24BBN518; Medline Kit Number/SKU CDS983173I: UDI/DI each 10195327170981, UDI/DI case 40195327170982, Lot Number: 23LBL541; Medline Kit Number/SKU CDS983173I: UDI/DI each 10195327170981, UDI/DI case 40195327170982, Lot Number: 23LBD588; Medline Kit Number/SKU CDS983493L: UDI/DI each 10193489275643, UDI/DI case 40193489275644, Lot Number: 23HDB332; Medline Kit Number/SKU CDS983493L: UDI/DI each 10193489275643, UDI/DI case 40193489275644, Lot Number: 23GDA495; Medline Kit Number/SKU CDS983493L: UDI/DI each 10193489275643, UDI/DI case 40193489275644, Lot Number: 23FDB617; Medline Kit Number/SKU CDS983493L: UDI/DI each 10193489275643, UDI/DI case 40193489275644, Lot Number: 23EDB945; Medline Kit Number/SKU CDS983493L: UDI/DI each 10193489275643, UDI/DI case 40193489275644, Lot Number: 22JDA727; Medline Kit Number/SKU CDS983493L: UDI/DI each 10193489275643, UDI/DI case 40193489275644, Lot Number: 22FDB173; Medline Kit Number/SKU CDS983493L: UDI/DI each 10193489275643, UDI/DI case 40193489275644, Lot Number: 21JDB599; Medline Kit Number/SKU CDS983493L: UDI/DI each 10193489275643, UDI/DI case 40193489275644, Lot Number: 21JDB403; Medline Kit Number/SKU CDS983493L: UDI/DI each 10193489275643, UDI/DI case 40193489275644, Lot Number: 21IDC321; Medline Kit Number/SKU CDS983493L: UDI/DI each 10193489275643, UDI/DI case 40193489275644, Lot Number: 21IDB329; Medline Kit Number/SKU CDS983493L: UDI/DI each 10193489275643, UDI/DI case 40193489275644, Lot Number: 21HDA478; Medline Kit Number/SKU CDS983493L: UDI/DI each 10193489275643, UDI/DI case 40193489275644, Lot Number: 21GDC463; Medline Kit Number/SKU CDS983493L: UDI/DI each 10193489275643, UDI/DI case 40193489275644, Lot Number: 21FDA896; Medline Kit Number/SKU CDS983493L: UDI/DI each 10193489275643, UDI/DI case 40193489275644, Lot Number: 21EDB291; Medline Kit Number/SKU CDS983493L: UDI/DI each 10193489275643, UDI/DI case 40193489275644, Lot Number: 21CDC134; Medline Kit Number/SKU CDS983493L: UDI/DI each 10193489275643, UDI/DI case 40193489275644, Lot Number: 21CDB258; Medline Kit Number/SKU CDS983493M: UDI/DI each 10195327497415, UDI/DI case 40195327497416, Lot Number: 24ADA328; Medline Kit Number/SKU CDS983493M: UDI/DI each 10195327497415, UDI/DI case 40195327497416, Lot Number: 23LDA144; Medline Kit Number/SKU CDS983493O: UDI/DI each 10198459335549, UDI/DI case 40198459335540, Lot Number: 26CDA415; Medline Kit Number/SKU CDS983493O: UDI/DI each 10198459335549, UDI/DI case 40198459335540, Lot Number: 26BDA065; Medline Kit Number/SKU CDS983493O: UDI/DI each 10198459335549, UDI/DI case 40198459335540, Lot Number: 25LDA842; Medline Kit Number/SKU CDS983493O: UDI/DI each 10198459335549, UDI/DI case 40198459335540, Lot Number: 25IDB325; Medline Kit Number/SKU DYNJ0395085P: UDI/DI each 10193489432718, UDI/DI case 40193489432719, Lot Number: 21DKA483; Medline Kit Number/SKU DYNJ0660040R: UDI/DI each 10889942220083, UDI/DI case 40889942220084, Lot Number: 23IMD698; Medline Kit Number/SKU DYNJ0660040R: UDI/DI each 10889942220083, UDI/DI case 40889942220084, Lot Number: 23GMB527; Medline Kit Number/SKU DYNJ0660040R: UDI/DI each 10889942220083, UDI/DI case 40889942220084, Lot Number: 23FMF102; Medline Kit Number/SKU DYNJ0660040R: UDI/DI each 10889942220083, UDI/DI case 40889942220084, Lot Number: 23EMH628; Medline Kit Number/SKU DYNJ0660040R: UDI/DI each 10889942220083, UDI/DI case 40889942220084, Lot Number: 23CMA614; Medline Kit Number/SKU DYNJ0660040R: UDI/DI each 10889942220083, UDI/DI case 40889942220084, Lot Number: 23BME548; Medline Kit Number/SKU DYNJ0660040R: UDI/DI each 10889942220083, UDI/DI case 40889942220084, Lot Number: 22JMB623; Medline Kit Number/SKU DYNJ0660040R: UDI/DI each 10889942220083, UDI/DI case 40889942220084, Lot Number: 22GMG727; Medline Kit Number/SKU DYNJ0660040R: UDI/DI each 10889942220083, UDI/DI case 40889942220084, Lot Number: 22FME591; Medline Kit Number/SKU DYNJ0660040R: UDI/DI each 10889942220083, UDI/DI case 40889942220084, Lot Number: 22DMG455; Medline Kit Number/SKU DYNJ0660040R: UDI/DI each 10889942220083, UDI/DI case 40889942220084, Lot Number: 26AMA936; Medline Kit Number/SKU DYNJ0660040R: UDI/DI each 10889942220083, UDI/DI case 40889942220084, Lot Number: 25KMG652; Medline Kit Number/SKU DYNJ0660040R: UDI/DI each 10889942220083, UDI/DI case 40889942220084, Lot Number: 25JME572; Medline Kit Number/SKU DYNJ0660040R: UDI/DI each 10889942220083, UDI/DI case 40889942220084, Lot Number: 25GMF834; Medline Kit Number/SKU DYNJ0660040R: UDI/DI each 10889942220083, UDI/DI case 40889942220084, Lot Number: 25EMA958; Medline Kit Number/SKU DYNJ0660040R: UDI/DI each 10889942220083, UDI/DI case 40889942220084, Lot Number: 25DME904; Medline Kit Number/SKU DYNJ0660040R: UDI/DI each 10889942220083, UDI/DI case 40889942220084, Lot Number: 25CME519; Medline Kit Number/SKU DYNJ0660040R: UDI/DI each 10889942220083, UDI/DI case 40889942220084, Lot Number: 24LMF057; Medline Kit Number/SKU DYNJ0660040R: UDI/DI each 10889942220083, UDI/DI case 40889942220084, Lot Number: 24JMH001; Medline Kit Number/SKU DYNJ0660040R: UDI/DI each 10889942220083, UDI/DI case 40889942220084, Lot Number: 24IMC603; Medline Kit Number/SKU DYNJ0660040R: UDI/DI each 10889942220083, UDI/DI case 40889942220084, Lot Number: 24HMA307; Medline Kit Number/SKU DYNJ0660040R: UDI/DI each 10889942220083, UDI/DI case 40889942220084, Lot Number: 24EMH324; Medline Kit Number/SKU DYNJ0660040R: UDI/DI each 10889942220083, UDI/DI case 40889942220084, Lot Number: 24EMA549; Medline Kit Number/SKU DYNJ0660040R: UDI/DI each 10889942220083, UDI/DI case 40889942220084, Lot Number: 24AMJ677; Medline Kit Number/SKU DYNJ0660040R: UDI/DI each 10889942220083, UDI/DI case 40889942220084, Lot Number: 23LMC624; Medline Kit Number/SKU DYNJ0785741L: UDI/DI each 10193489935080, UDI/DI case 40193489935081, Lot Number: 23IMG288; Medline Kit Number/SKU DYNJ0785741L: UDI/DI each 10193489935080, UDI/DI case 40193489935081, Lot Number: 23GMF398; Medline Kit Number/SKU DYNJ0785741L: UDI/DI each 10193489935080, UDI/DI case 40193489935081, Lot Number: 23FMH043; Medline Kit Number/SKU DYNJ0785741L: UDI/DI each 10193489935080, UDI/DI case 40193489935081, Lot Number: 23FMD596; Medline Kit Number/SKU DYNJ0785741L: UDI/DI each 10193489935080, UDI/DI case 40193489935081, Lot Number: 23EMF866; Medline Kit Number/SKU DYNJ0785741L: UDI/DI each 10193489935080, UDI/DI case 40193489935081, Lot Number: 23DMH874; Medline Kit Number/SKU DYNJ0785741L: UDI/DI each 10193489935080, UDI/DI case 40193489935081, Lot Number: 23CMH139; Medline Kit Number/SKU DYNJ0785741L: UDI/DI each 10193489935080, UDI/DI case 40193489935081, Lot Number: 23CME193; Medline Kit Number/SKU DYNJ0785741L: UDI/DI each 10193489935080, UDI/DI case 40193489935081, Lot Number: 23BMD471; Medline Kit Number/SKU DYNJ0785741L: UDI/DI each 10193489935080, UDI/DI case 40193489935081, Lot Number: 22LMD522; Medline Kit Number/SKU DYNJ0785741L: UDI/DI each 10193489935080, UDI/DI case 40193489935081, Lot Number: 22HMG591; Medline Kit Number/SKU DYNJ0785741L: UDI/DI each 10193489935080, UDI/DI case 40193489935081, Lot Number: 22GME991; Medline Kit Number/SKU DYNJ0785741L: UDI/DI each 10193489935080, UDI/DI case 40193489935081, Lot Number: 22GME992; Medline Kit Number/SKU DYNJ0785741L: UDI/DI each 10193489935080, UDI/DI case 40193489935081, Lot Number: 22DMC069; Medline Kit Number/SKU DYNJ0785741L: UDI/DI each 10193489935080, UDI/DI case 40193489935081, Lot Number: 22OBD206; Medline Kit Number/SKU DYNJ0785741L: UDI/DI each 10193489935080, UDI/DI case 40193489935081, Lot Number: 22CBF109; Medline Kit Number/SKU DYNJ0785741L: UDI/DI each 10193489935080, UDI/DI case 40193489935081, Lot Number: 21IBM538; Medline Kit Number/SKU DYNJ0785741L: UDI/DI each 10193489935080, UDI/DI case 40193489935081, Lot Number: 21IBM610; Medline Kit Number/SKU DYNJ0785741L: UDI/DI each 10193489935080, UDI/DI case 40193489935081, Lot Number: 21FBP997; Medline Kit Number/SKU DYNJ0785741L: UDI/DI each 10193489935080, UDI/DI case 40193489935081, Lot Number: 24JMH447; Medline Kit Number/SKU DYNJ0785741L: UDI/DI each 10193489935080, UDI/DI case 40193489935081, Lot Number: 24IMF995; Medline Kit Number/SKU DYNJ0785741L: UDI/DI each 10193489935080, UDI/DI case 40193489935081, Lot Number: 24FMI942; Medline Kit Number/SKU DYNJ0785741L: UDI/DI each 10193489935080, UDI/DI case 40193489935081, Lot Number: 24EME920; Medline Kit Number/SKU DYNJ0785741L: UDI/DI each 10193489935080, UDI/DI case 40193489935081, Lot Number: 24DMJ136; Medline Kit Number/SKU DYNJ0785741L: UDI/DI each 10193489935080, UDI/DI case 40193489935081, Lot Number: 23LMH895; Medline Kit Number/SKU DYNJ0991320L: UDI/DI each 10195327028541, UDI/DI case 40195327028542, Lot Number: 23KMC601; Medline Kit Number/SKU DYNJ0991320L: UDI/DI each 10195327028541, UDI/DI case 40195327028542, Lot Number: 23GMC715; Medline Kit Number/SKU DYNJ0991320L: UDI/DI each 10195327028541, UDI/DI case 40195327028542, Lot Number: 23DME468; Medline Kit Number/SKU DYNJ0991320L: UDI/DI each 10195327028541, UDI/DI case 40195327028542, Lot Number: 23BMC887; Medline Kit Number/SKU DYNJ0991320L: UDI/DI each 10195327028541, UDI/DI case 40195327028542, Lot Number: 21LLA690; Medline Kit Number/SKU DYNJ0991320L: UDI/DI each 10195327028541, UDI/DI case 40195327028542, Lot Number: 24BMA691; Medline Kit Number/SKU DYNJ0991320L: UDI/DI each 10195327028541, UDI/DI case 40195327028542, Lot Number: 24AMH656; Medline Kit Number/SKU DYNJ0991320L: UDI/DI each 10195327028541, UDI/DI case 40195327028542, Lot Number: 23LMB786; Medline Kit Number/SKU DYNJ39211F: UDI/DI each 10195327313654, UDI/DI case 40195327313655, Lot Number: 23BMD216; Medline Kit Number/SKU DYNJ40648F: UDI/DI each 10889942611041, UDI/DI case 40889942611042, Lot Number: 22AMG375; Medline Kit Number/SKU DYNJ40648F: UDI/DI each 10889942611041, UDI/DI case 40889942611042, Lot Number: 21KMG254; Medline Kit Number/SKU DYNJ40648F: UDI/DI each 10889942611041, UDI/DI case 40889942611042, Lot Number: 21HMB060; Medline Kit Number/SKU DYNJ40648F: UDI/DI each 10889942611041, UDI/DI case 40889942611042, Lot Number: 21FMD643; Medline Kit Number/SKU DYNJ40648F: UDI/DI each 10889942611041, UDI/DI case 40889942611042, Lot Number: 21DME180; Medline Kit Number/SKU DYNJ41922C: UDI/DI each 10193489677355, UDI/DI case 40193489677356, Lot Number: 23IBB468; Medline Kit Number/SKU DYNJ41922C: UDI/DI each 10193489677355, UDI/DI case 40193489677356, Lot Number: 23FBO732; Medline Kit Number/SKU DYNJ41922C: UDI/DI each 10193489677355, UDI/DI case 40193489677356, Lot Number: 23EBV753; Medline Kit Number/SKU DYNJ41922C: UDI/DI each 10193489677355, UDI/DI case 40193489677356, Lot Number: 23EBQ610; Medline Kit Number/SKU DYNJ41922C: UDI/DI each 10193489677355, UDI/DI case 40193489677356, Lot Number: 23DBM685; Medline Kit Number/SKU DYNJ41922C: UDI/DI each 10193489677355, UDI/DI case 40193489677356, Lot Number: 23ABH385; Medline Kit Number/SKU DYNJ41922C: UDI/DI each 10193489677355, UDI/DI case 40193489677356, Lot Number: 22GBK343; Medline Kit Number/SKU DYNJ41922C: UDI/DI each 10193489677355, UDI/DI case 40193489677356, Lot Number: 22EBB123; Medline Kit Number/SKU DYNJ41922C: UDI/DI each 10193489677355, UDI/DI case 40193489677356, Lot Number: 22ABE215; Medline Kit Number/SKU DYNJ41922C: UDI/DI each 10193489677355, UDI/DI case 40193489677356, Lot Number: 21ABM833; Medline Kit Number/SKU DYNJ41922C: UDI/DI each 10193489677355, UDI/DI case 40193489677356, Lot Number: 24JBE450; Medline Kit Number/SKU DYNJ41922C: UDI/DI each 10193489677355, UDI/DI case 40193489677356, Lot Number: 24JBF281; Medline Kit Number/SKU DYNJ41922C: UDI/DI each 10193489677355, UDI/DI case 40193489677356, Lot Number: 24JBA800; Medline Kit Number/SKU DYNJ41922C: UDI/DI each 10193489677355, UDI/DI case 40193489677356, Lot Number: 24IBT612; Medline Kit Number/SKU DYNJ41922C: UDI/DI each 10193489677355, UDI/DI case 40193489677356, Lot Number: 24FBS381; Medline Kit Number/SKU DYNJ41922C: UDI/DI each 10193489677355, UDI/DI case 40193489677356, Lot Number: 23LBN005; Medline Kit Number/SKU DYNJ42833B: UDI/DI each 10193489880335, UDI/DI case 40193489880336, Lot Number: 26BBK430; Medline Kit Number/SKU DYNJ42833B: UDI/DI each 10193489880335, UDI/DI case 40193489880336, Lot Number: 25JBU219; Medline Kit Number/SKU DYNJ42833B: UDI/DI each 10193489880335, UDI/DI case 40193489880336, Lot Number: 25GBW762; Medline Kit Number/SKU DYNJ42833B: UDI/DI each 10193489880335, UDI/DI case 40193489880336, Lot Number: 25DBU105; Medline Kit Number/SKU DYNJ43859J: UDI/DI each 10193489893700, UDI/DI case 40193489893701, Lot Number: 23EME342; Medline Kit Number/SKU DYNJ44759F: UDI/DI each 10193489789935, UDI/DI case 40193489789936, Lot Number: 22IBI991; Medline Kit Number/SKU DYNJ44759F: UDI/DI each 10193489789935, UDI/DI case 40193489789936, Lot Number: 22EBP134; Medline Kit Number/SKU DYNJ44759F: UDI/DI each 10193489789935, UDI/DI case 40193489789936, Lot Number: 22ABX616; Medline Kit Number/SKU DYNJ44759F: UDI/DI each 10193489789935, UDI/DI case 40193489789936, Lot Number: 22ABA063; Medline Kit Number/SKU DYNJ44759F: UDI/DI each 10193489789935, UDI/DI case 40193489789936, Lot Number: 21JBD678; Medline Kit Number/SKU DYNJ44759F: UDI/DI each 10193489789935, UDI/DI case 40193489789936, Lot Number: 21HBQ587; Medline Kit Number/SKU DYNJ44759F: UDI/DI each 10193489789935, UDI/DI case 40193489789936, Lot Number: 21DBC693; Medline Kit Number/SKU DYNJ46504C: UDI/DI each 10195327005221, UDI/DI case 40195327005222, Lot Number: 23GME117; Medline Kit Number/SKU DYNJ46504C: UDI/DI each 10195327005221, UDI/DI case 40195327005222, Lot Number: 23EMI284; Medline Kit Number/SKU DYNJ46504C: UDI/DI each 10195327005221, UDI/DI case 40195327005222, Lot Number: 23AMJ001; Medline Kit Number/SKU DYNJ46504C: UDI/DI each 10195327005221, UDI/DI case 40195327005222, Lot Number: 22KMD020; Medline Kit Number/SKU DYNJ46504C: UDI/DI each 10195327005221, UDI/DI case 40195327005222, Lot Number: 22GBW975; Medline Kit Number/SKU DYNJ46504C: UDI/DI each 10195327005221, UDI/DI case 40195327005222, Lot Number: 22FBW091; Medline Kit Number/SKU DYNJ46504C: UDI/DI each 10195327005221, UDI/DI case 40195327005222, Lot Number: 22OBJ071; Medline Kit Number/SKU DYNJ46504C: UDI/DI each 10195327005221, UDI/DI case 40195327005222, Lot Number: 22CBC147; Medline Kit Number/SKU DYNJ46504C: UDI/DI each 10195327005221, UDI/DI case 40195327005222, Lot Number: 21VBD092; Medline Kit Number/SKU DYNJ46504D: UDI/DI each 10195327477585, UDI/DI case 40195327477586, Lot Number: 23HMG668; Medline Kit Number/SKU DYNJ46504D: UDI/DI each 10195327477585, UDI/DI case 40195327477586, Lot Number: 24JMC633; Medline Kit Number/SKU DYNJ46504D: UDI/DI each 10195327477585, UDI/DI case 40195327477586, Lot Number: 24IMI654; Medline Kit Number/SKU DYNJ46504D: UDI/DI each 10195327477585, UDI/DI case 40195327477586, Lot Number: 24IMB838; Medline Kit Number/SKU DYNJ46504D: UDI/DI each 10195327477585, UDI/DI case 40195327477586, Lot Number: 24HMB162; Medline Kit Number/SKU DYNJ46504D: UDI/DI each 10195327477585, UDI/DI case 40195327477586, Lot Number: 24FMG045; Medline Kit Number/SKU DYNJ46504D: UDI/DI each 10195327477585, UDI/DI case 40195327477586, Lot Number: 24EMD442; Medline Kit Number/SKU DYNJ46504D: UDI/DI each 10195327477585, UDI/DI case 40195327477586, Lot Number: 24DME855; Medline Kit Number/SKU DYNJ46504D: UDI/DI each 10195327477585, UDI/DI case 40195327477586, Lot Number: 24CMH418; Medline Kit Number/SKU DYNJ46504D: UDI/DI each 10195327477585, UDI/DI case 40195327477586, Lot Number: 24BMK020; Medline Kit Number/SKU DYNJ46504D: UDI/DI each 10195327477585, UDI/DI case 40195327477586, Lot Number: 24AMG855; Medline Kit Number/SKU DYNJ46504D: UDI/DI each 10195327477585, UDI/DI case 40195327477586, Lot Number: 24AMB928; Medline Kit Number/SKU DYNJ46504F: UDI/DI each 10198459140761, UDI/DI case 40198459140762, Lot Number: 25HMI601; Medline Kit Number/SKU DYNJ46504F: UDI/DI each 10198459140761, UDI/DI case 40198459140762, Lot Number: 25GMG101; Medline Kit Number/SKU DYNJ46504F: UDI/DI each 10198459140761, UDI/DI case 40198459140762, Lot Number: 25EMF342; Medline Kit Number/SKU DYNJ46781B: UDI/DI each 10193489825916, UDI/DI case 40193489825917, Lot Number: 22JBA979; Medline Kit Number/SKU DYNJ46781B: UDI/DI each 10193489825916, UDI/DI case 40193489825917, Lot Number: 26BBR125; Medline Kit Number/SKU DYNJ46781B: UDI/DI each 10193489825916, UDI/DI case 40193489825917, Lot Number: 25KBQ493; Medline Kit Number/SKU DYNJ46781B: UDI/DI each 10193489825916, UDI/DI case 40193489825917, Lot Number: 24JBD583; Medline Kit Number/SKU DYNJ46781B: UDI/DI each 10193489825916, UDI/DI case 40193489825917, Lot Number: 24HBA712; Medline Kit Number/SKU DYNJ46781B: UDI/DI each 10193489825916, UDI/DI case 40193489825917, Lot Number: 24EBM092; Medline Kit Number/SKU DYNJ46781B: UDI/DI each 10193489825916, UDI/DI case 40193489825917, Lot Number: 24DBK313; Medline Kit Number/SKU DYNJ46781B: UDI/DI each 10193489825916, UDI/DI case 40193489825917, Lot Number: 24BBO353; Medline Kit Number/SKU DYNJ48191G: UDI/DI each 10193489476606, UDI/DI case 40193489476607, Lot Number: 21JMH268; Medline Kit Number/SKU DYNJ48191G: UDI/DI each 10193489476606, UDI/DI case 40193489476607, Lot Number: 21JMF238; Medline Kit Number/SKU DYNJ48191G: UDI/DI each 10193489476606, UDI/DI case 40193489476607, Lot Number: 21DMB033; Medline Kit Number/SKU DYNJ48191I: UDI/DI each 10195327057817, UDI/DI case 40195327057818, Lot Number: 22EME800; Medline Kit Number/SKU DYNJ48191I: UDI/DI each 10195327057817, UDI/DI case 40195327057818, Lot Number: 22CMD031; Medline Kit Number/SKU DYNJ48191J: UDI/DI each 10195327255039, UDI/DI case 40195327255030, Lot Number: 23EMA429; Medline Kit Number/SKU DYNJ48191J: UDI/DI each 10195327255039, UDI/DI case 40195327255030, Lot Number: 23BMD353; Medline Kit Number/SKU DYNJ48191J: UDI/DI each 10195327255039, UDI/DI case 40195327255030, Lot Number: 22LMH655; Medline Kit Number/SKU DYNJ48191J: UDI/DI each 10195327255039, UDI/DI case 40195327255030, Lot Number: 22JME786; Medline Kit Number/SKU DYNJ48191K: UDI/DI each 10195327437541, UDI/DI case 40195327437542, Lot Number: 23GMG423; Medline Kit Number/SKU DYNJ48191K: UDI/DI each 10195327437541, UDI/DI case 40195327437542, Lot Number: 23LMH905; Medline Kit Number/SKU DYNJ48191L: UDI/DI each 10195327630690, UDI/DI case 40195327630691, Lot Number: 24EMH956; Medline Kit Number/SKU DYNJ48191M: UDI/DI each 10198459078910, UDI/DI case 40198459078911, Lot Number: 25GMD380; Medline Kit Number/SKU DYNJ48191M: UDI/DI each 10198459078910, UDI/DI case 40198459078911, Lot Number: 25EMA899; Medline Kit Number/SKU DYNJ48191M: UDI/DI each 10198459078910, UDI/DI case 40198459078911, Lot Number: 25BMD703; Medline Kit Number/SKU DYNJ48191M: UDI/DI each 10198459078910, UDI/DI case 40198459078911, Lot Number: 25BMB374; Medline Kit Number/SKU DYNJ48191O: UDI/DI each 10198459602641, UDI/DI case 40198459602642, Lot Number: 26AMB007; Medline Kit Number/SKU DYNJ53076D: UDI/DI each 10193489239119, UDI/DI case 40193489239110, Lot Number: 21JMD339; Medline Kit Number/SKU DYNJ53076D: UDI/DI each 10193489239119, UDI/DI case 40193489239110, Lot Number: 21FMF721; Medline Kit Number/SKU DYNJ53076D: UDI/DI each 10193489239119, UDI/DI case 40193489239110, Lot Number: 21FME498; Medline Kit Number/SKU DYNJ53076D: UDI/DI each 10193489239119, UDI/DI case 40193489239110, Lot Number: 21EMA403; Medline Kit Number/SKU DYNJ54761B: UDI/DI each 10193489434286, UDI/DI case 40193489434287, Lot Number: 21HBG397; Medline Kit Number/SKU DYNJ54761B: UDI/DI each 10193489434286, UDI/DI case 40193489434287, Lot Number: 21FBE715; Medline Kit Number/SKU DYNJ54761B: UDI/DI each 10193489434286, UDI/DI case 40193489434287, Lot Number: 21CBW195; Medline Kit Number/SKU DYNJ54761B: UDI/DI each 10193489434286, UDI/DI case 40193489434287, Lot Number: 21ABG033; Medline Kit Number/SKU DYNJ54761B: UDI/DI each 10193489434286, UDI/DI case 40193489434287, Lot Number: 21ABH228; Medline Kit Number/SKU DYNJ54761C: UDI/DI each 10195327020217, UDI/DI case 40195327020218, Lot Number: 23JBY274; Medline Kit Number/SKU DYNJ54761C: UDI/DI each 10195327020217, UDI/DI case 40195327020218, Lot Number: 23FBM738; Medline Kit Number/SKU DYNJ54761C: UDI/DI each 10195327020217, UDI/DI case 40195327020218, Lot Number: 23EBS795; Medline Kit Number/SKU DYNJ54761C: UDI/DI each 10195327020217, UDI/DI case 40195327020218, Lot Number: 23DBQ176; Medline Kit Number/SKU DYNJ54761C: UDI/DI each 10195327020217, UDI/DI case 40195327020218, Lot Number: 23DBB931; Medline Kit Number/SKU DYNJ54761C: UDI/DI each 10195327020217, UDI/DI case 40195327020218, Lot Number: 23CBB075; Medline Kit Number/SKU DYNJ54761C: UDI/DI each 10195327020217, UDI/DI case 40195327020218, Lot Number: 23BBC518; Medline Kit Number/SKU DYNJ54761C: UDI/DI each 10195327020217, UDI/DI case 40195327020218, Lot Number: 22JBD638; Medline Kit Number/SKU DYNJ54761C: UDI/DI each 10195327020217, UDI/DI case 40195327020218, Lot Number: 22FBJ435; Medline Kit Number/SKU DYNJ54761C: UDI/DI each 10195327020217, UDI/DI case 40195327020218, Lot Number: 22EBL603; Medline Kit Number/SKU DYNJ54761C: UDI/DI each 10195327020217, UDI/DI case 40195327020218, Lot Number: 22CBV860; Medline Kit Number/SKU DYNJ54761C: UDI/DI each 10195327020217, UDI/DI case 40195327020218, Lot Number: 22CBP225; Medline Kit Number/SKU DYNJ54761C: UDI/DI each 10195327020217, UDI/DI case 40195327020218, Lot Number: 21LBU279; Medline Kit Number/SKU DYNJ54761C: UDI/DI each 10195327020217, UDI/DI case 40195327020218, Lot Number: 21KBP799; Medline Kit Number/SKU DYNJ54761C: UDI/DI each 10195327020217, UDI/DI case 40195327020218, Lot Number: 26CBB708; Medline Kit Number/SKU DYNJ54761C: UDI/DI each 10195327020217, UDI/DI case 40195327020218, Lot Number: 26ABM764; Medline Kit Number/SKU DYNJ54761C: UDI/DI each 10195327020217, UDI/DI case 40195327020218, Lot Number: 25LBQ922; Medline Kit Number/SKU DYNJ54761C: UDI/DI each 10195327020217, UDI/DI case 40195327020218, Lot Number: 25KBI476; Medline Kit Number/SKU DYNJ54761C: UDI/DI each 10195327020217, UDI/DI case 40195327020218, Lot Number: 25IBS238; Medline Kit Number/SKU DYNJ54761C: UDI/DI each 10195327020217, UDI/DI case 40195327020218, Lot Number: 25IBB148; Medline Kit Number/SKU DYNJ54761C: UDI/DI each 10195327020217, UDI/DI case 40195327020218, Lot Number: 25HBM494; Medline Kit Number/SKU DYNJ54761C: UDI/DI each 10195327020217, UDI/DI case 40195327020218, Lot Number: 25FBI994; Medline Kit Number/SKU DYNJ54761C: UDI/DI each 10195327020217, UDI/DI case 40195327020218, Lot Number: 25DBU225; Medline Kit Number/SKU DYNJ54761C: UDI/DI each 10195327020217, UDI/DI case 40195327020218, Lot Number: 25BBE810; Medline Kit Number/SKU DYNJ54761C: UDI/DI each 10195327020217, UDI/DI case 40195327020218, Lot Number: 25ABK916; Medline Kit Number/SKU DYNJ54761C: UDI/DI each 10195327020217, UDI/DI case 40195327020218, Lot Number: 24LBB828; Medline Kit Number/SKU DYNJ54761C: UDI/DI each 10195327020217, UDI/DI case 40195327020218, Lot Number: 24JBX741; Medline Kit Number/SKU DYNJ54761C: UDI/DI each 10195327020217, UDI/DI case 40195327020218, Lot Number: 24IBR297; Medline Kit Number/SKU DYNJ54761C: UDI/DI each 10195327020217, UDI/DI case 40195327020218, Lot Number: 24HBI405; Medline Kit Number/SKU DYNJ54761C: UDI/DI each 10195327020217, UDI/DI case 40195327020218, Lot Number: 24FBP312; Medline Kit Number/SKU DYNJ54761C: UDI/DI each 10195327020217, UDI/DI case 40195327020218, Lot Number: 24EBN616; Medline Kit Number/SKU DYNJ54761C: UDI/DI each 10195327020217, UDI/DI case 40195327020218, Lot Number: 24CBL687; Medline Kit Number/SKU DYNJ54761C: UDI/DI each 10195327020217, UDI/DI case 40195327020218, Lot Number: 24CBJ095; Medline Kit Number/SKU DYNJ54761C: UDI/DI each 10195327020217, UDI/DI case 40195327020218, Lot Number: 24BBS591; Medline Kit Number/SKU DYNJ57604: UDI/DI each 10889942756902, UDI/DI case 40889942756903, Lot Number: 23IBD079; Medline Kit Number/SKU DYNJ57604: UDI/DI each 10889942756902, UDI/DI case 40889942756903, Lot Number: 23GBL994; Medline Kit Number/SKU DYNJ57604: UDI/DI each 10889942756902, UDI/DI case 40889942756903, Lot Number: 23EBS598; Medline Kit Number/SKU DYNJ57604: UDI/DI each 10889942756902, UDI/DI case 40889942756903, Lot Number: 23EBL984; Medline Kit Number/SKU DYNJ57604: UDI/DI each 10889942756902, UDI/DI case 40889942756903, Lot Number: 23DBH411; Medline Kit Number/SKU DYNJ57604: UDI/DI each 10889942756902, UDI/DI case 40889942756903, Lot Number: 23CBV513; Medline Kit Number/SKU DYNJ57604: UDI/DI each 10889942756902, UDI/DI case 40889942756903, Lot Number: 23BBD492; Medline Kit Number/SKU DYNJ57604: UDI/DI each 10889942756902, UDI/DI case 40889942756903, Lot Number: 22DBQ354; Medline Kit Number/SKU DYNJ57604: UDI/DI each 10889942756902, UDI/DI case 40889942756903, Lot Number: 22BBB405; Medline Kit Number/SKU DYNJ57604: UDI/DI each 10889942756902, UDI/DI case 40889942756903, Lot Number: 21KBW367; Medline Kit Number/SKU DYNJ57604: UDI/DI each 10889942756902, UDI/DI case 40889942756903, Lot Number: 21KBC969; Medline Kit Number/SKU DYNJ57604: UDI/DI each 10889942756902, UDI/DI case 40889942756903, Lot Number: 21FBE526; Medline Kit Number/SKU DYNJ57604: UDI/DI each 10889942756902, UDI/DI case 40889942756903, Lot Number: 21FBE506; Medline Kit Number/SKU DYNJ57604: UDI/DI each 10889942756902, UDI/DI case 40889942756903, Lot Number: 21DBM118; Medline Kit Number/SKU DYNJ57604: UDI/DI each 10889942756902, UDI/DI case 40889942756903, Lot Number: 21DBD151; Medline Kit Number/SKU DYNJ57604: UDI/DI each 10889942756902, UDI/DI case 40889942756903, Lot Number: 21BBA803; Medline Kit Number/SKU DYNJ57604: UDI/DI each 10889942756902, UDI/DI case 40889942756903, Lot Number: 21ABF228; Medline Kit Number/SKU DYNJ57604: UDI/DI each 10889942756902, UDI/DI case 40889942756903, Lot Number: 26BBS083; Medline Kit Number/SKU DYNJ57604: UDI/DI each 10889942756902, UDI/DI case 40889942756903, Lot Number: 25IBE859; Medline Kit Number/SKU DYNJ57604: UDI/DI each 10889942756902, UDI/DI case 40889942756903, Lot Number: 25BBJ593; Medline Kit Number/SKU DYNJ57604: UDI/DI each 10889942756902, UDI/DI case 40889942756903, Lot Number: 25BBJ601; Medline Kit Number/SKU DYNJ57604: UDI/DI each 10889942756902, UDI/DI case 40889942756903, Lot Number: 24HBD973; Medline Kit Number/SKU DYNJ57604: UDI/DI each 10889942756902, UDI/DI case 40889942756903, Lot Number: 24FBB019; Medline Kit Number/SKU DYNJ57604: UDI/DI each 10889942756902, UDI/DI case 40889942756903, Lot Number: 24CBK963; Medline Kit Number/SKU DYNJ57604: UDI/DI each 10889942756902, UDI/DI case 40889942756903, Lot Number: 23KBX604; Medline Kit Number/SKU DYNJ59400K: UDI/DI each 10195327492489, UDI/DI case 40195327492480, Lot Number: 24GMC759; Medline Kit Number/SKU DYNJ59456A: UDI/DI each 10193489362060, UDI/DI case 40193489362061, Lot Number: 23IBC981; Medline Kit Number/SKU DYNJ59456A: UDI/DI each 10193489362060, UDI/DI case 40193489362061, Lot Number: 23CBB054; Medline Kit Number/SKU DYNJ59456A: UDI/DI each 10193489362060, UDI/DI case 40193489362061, Lot Number: 23ABK120; Medline Kit Number/SKU DYNJ59456A: UDI/DI each 10193489362060, UDI/DI case 40193489362061, Lot Number: 22GBU138; Medline Kit Number/SKU DYNJ59456A: UDI/DI each 10193489362060, UDI/DI case 40193489362061, Lot Number: 22BBT750; Medline Kit Number/SKU DYNJ59456A: UDI/DI each 10193489362060, UDI/DI case 40193489362061, Lot Number: 21JBZ859; Medline Kit Number/SKU DYNJ59456A: UDI/DI each 10193489362060, UDI/DI case 40193489362061, Lot Number: 21FBA944; Medline Kit Number/SKU DYNJ59456A: UDI/DI each 10193489362060, UDI/DI case 40193489362061, Lot Number: 21ABM493; Medline Kit Number/SKU DYNJ59456A: UDI/DI each 10193489362060, UDI/DI case 40193489362061, Lot Number: 26BBG778; Medline Kit Number/SKU DYNJ59456A: UDI/DI each 10193489362060, UDI/DI case 4
Quantity Affected: 22116 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-2025-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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