Medline medical procedure kits, containing Medline Neuro Sponges (102 in total) — FDA record Z-2025-2026

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 (102 in total)
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
22116 kits
Agency-reported status
Ongoing
Source record identifier
Z-2025-2026

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 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 ea...

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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