- 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 BIOB110: UDI/DI each 10889942758043, UDI/DI case 40889942758044, Lot Number: 24HBM826; Medline Kit Number/SKU CDS780056M: UDI/DI each 10195327045562, UDI/DI case 40195327045563, Lot Number: 23KBK939; Medline Kit Number/SKU CDS780056M: UDI/DI each 10195327045562, UDI/DI case 40195327045563, Lot Number: 23JBD164; Medline Kit Number/SKU CDS780056M: UDI/DI each 10195327045562, UDI/DI case 40195327045563, Lot Number: 23HBJ252; Medline Kit Number/SKU CDS780056M: UDI/DI each 10195327045562, UDI/DI case 40195327045563, Lot Number: 23EBV328; Medline Kit Number/SKU CDS780056M: UDI/DI each 10195327045562, UDI/DI case 40195327045563, Lot Number: 23DBD983; Medline Kit Number/SKU CDS780056M: UDI/DI each 10195327045562, UDI/DI case 40195327045563, Lot Number: 23BBR624; Medline Kit Number/SKU CDS780056M: UDI/DI each 10195327045562, UDI/DI case 40195327045563, Lot Number: 23BBM647; Medline Kit Number/SKU CDS780056M: UDI/DI each 10195327045562, UDI/DI case 40195327045563, Lot Number: 23BBB199; Medline Kit Number/SKU CDS780056M: UDI/DI each 10195327045562, UDI/DI case 40195327045563, Lot Number: 23ABR879; Medline Kit Number/SKU CDS780056M: UDI/DI each 10195327045562, UDI/DI case 40195327045563, Lot Number: 23ABK516; Medline Kit Number/SKU CDS780056M: UDI/DI each 10195327045562, UDI/DI case 40195327045563, Lot Number: 22KBO464; Medline Kit Number/SKU CDS780056M: UDI/DI each 10195327045562, UDI/DI case 40195327045563, Lot Number: 22IBD725; Medline Kit Number/SKU CDS780056M: UDI/DI each 10195327045562, UDI/DI case 40195327045563, Lot Number: 22FBH811; Medline Kit Number/SKU CDS780056M: UDI/DI each 10195327045562, UDI/DI case 40195327045563, Lot Number: 22DBG358; Medline Kit Number/SKU CDS780056M: UDI/DI each 10195327045562, UDI/DI case 40195327045563, Lot Number: 22CBS385; Medline Kit Number/SKU CDS780056M: UDI/DI each 10195327045562, UDI/DI case 40195327045563, Lot Number: 22ABG822; Medline Kit Number/SKU CDS780056M: UDI/DI each 10195327045562, UDI/DI case 40195327045563, Lot Number: 24CBK278; Medline Kit Number/SKU CDS780056M: UDI/DI each 10195327045562, UDI/DI case 40195327045563, Lot Number: 24CBG921; Medline Kit Number/SKU CDS780056M: UDI/DI each 10195327045562, UDI/DI case 40195327045563, Lot Number: 24BBM090; Medline Kit Number/SKU CDS780056M: UDI/DI each 10195327045562, UDI/DI case 40195327045563, Lot Number: 24ABK179; Medline Kit Number/SKU CDS780056N: UDI/DI each 10195327645533, UDI/DI case 40195327645534, Lot Number: 26ABC519; Medline Kit Number/SKU CDS780056N: UDI/DI each 10195327645533, UDI/DI case 40195327645534, Lot Number: 25JBY144; Medline Kit Number/SKU CDS780056N: UDI/DI each 10195327645533, UDI/DI case 40195327645534, Lot Number: 25GBU677; Medline Kit Number/SKU CDS780056N: UDI/DI each 10195327645533, UDI/DI case 40195327645534, Lot Number: 25FBK528; Medline Kit Number/SKU CDS780056N: UDI/DI each 10195327645533, UDI/DI case 40195327645534, Lot Number: 25EBM571; Medline Kit Number/SKU CDS780056N: UDI/DI each 10195327645533, UDI/DI case 40195327645534, Lot Number: 25DBA260; Medline Kit Number/SKU CDS780056N: UDI/DI each 10195327645533, UDI/DI case 40195327645534, Lot Number: 25BBD145; Medline Kit Number/SKU CDS780056N: UDI/DI each 10195327645533, UDI/DI case 40195327645534, Lot Number: 24KBA043; Medline Kit Number/SKU CDS780056N: UDI/DI each 10195327645533, UDI/DI case 40195327645534, Lot Number: 24JBQ514; Medline Kit Number/SKU CDS780056N: UDI/DI each 10195327645533, UDI/DI case 40195327645534, Lot Number: 24JBE904; Medline Kit Number/SKU CDS780056N: UDI/DI each 10195327645533, UDI/DI case 40195327645534, Lot Number: 24HBT002; Medline Kit Number/SKU CDS840490K: UDI/DI each 10193489434811, UDI/DI case 40193489434812, Lot Number: 23ABC251; Medline Kit Number/SKU CDS840490K: UDI/DI each 10193489434811, UDI/DI case 40193489434812, Lot Number: 23ABA109; Medline Kit Number/SKU CDS840490K: UDI/DI each 10193489434811, UDI/DI case 40193489434812, L
- Units affected
- 263739 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-2027-2026
- 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