Recall archive / FDA device enforcement
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
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 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.