- 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 AM310B: UDI/DI each 10193489242126, UDI/DI case 40193489242127, Lot Number: 20XBG776; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 23JBF547; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 23GBK604; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 23DBO915; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 23DBD581; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 23ABP476; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 23ABD648; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 22LBE888; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 22HBL188; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 22HBF976; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 22FBN678; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 22DBK641; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 22BBU367; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 22ABD373; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 21JBC146; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 21IBA072; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 21FBN768; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 21FBB075; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 21EBI490; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 24CBU365; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 24BBE020; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 24ABJ712; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 23LBM852; Medline Kit Number/SKU CDS980579F: UDI/DI each 10198459027734, UDI/DI case 40198459027735, Lot Number: 26BBM084; Medline Kit Number/SKU CDS980579F: UDI/DI each 10198459027734, UDI/DI case 40198459027735, Lot Number: 25LBS053; Medline Kit Number/SKU CDS980579F: UDI/DI each 10198459027734, UDI/DI case 40198459027735, Lot Number: 25KBL217; Medline Kit Number/SKU CDS980579F: UDI/DI each 10198459027734, UDI/DI case 40198459027735, Lot Number: 25JBA568; Medline Kit Number/SKU CDS980579F: UDI/DI each 10198459027734, UDI/DI case 40198459027735, Lot Number: 25GBM602; Medline Kit Number/SKU CDS980579F: UDI/DI each 10198459027734, UDI/DI case 40198459027735, Lot Number: 25FBB309; Medline Kit Number/SKU CDS980579F: UDI/DI each 10198459027734, UDI/DI case 40198459027735, Lot Number: 25CBN201; Medline Kit Number/SKU CDS980579F: UDI/DI each 10198459027734, UDI/DI case 40198459027735, Lot Number: 25CBI539; Medline Kit Number/SKU CDS980579F: UDI/DI each 10198459027734, UDI/DI case 40198459027735, Lot Number: 24KBJ971; Medline Kit Number/SKU CDS980579F: UDI/DI each 10198459027734, UDI/DI case 40198459027735, Lot Number: 24IBV278; Medline Kit Number/SKU CDS980579F: UDI/DI each 10198459027734, UDI/DI case 40198459027735, Lot Number: 24IBR437; Medline Kit Number/SKU CDS980579F: UDI/DI each 10198459027734, UDI/DI case 40198459027735, Lo
- Units affected
- 486946 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-2021-2026
- 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