- Recalling firm
- Medline Industries, LP
- 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.
- Affected products (lot / model / serial)
- 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
- Units affected
- 22116 kits
- Distribution pattern
- Worldwide distribution.
- Firm location
- Northfield, IL, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2025-2026
- Recall initiated
- March 19, 2026
- FDA classification date
- April 30, 2026
- FDA report date
- May 6, 2026
- FDA event ID
- 98664
- Last updated on HTM Vibe
- July 24, 2026