- 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 DYNJ86657A, UDI/DI each 10198459431678, UDI/DI case 40198459431679, Lot Number: 26ABM977; Medline Kit Number/SKU DYNJ86657A, UDI/DI each 10198459431678, UDI/DI case 40198459431679, Lot Number: 25KBM387; Medline Kit Number/SKU DYNJ86657A, UDI/DI each 10198459431678, UDI/DI case 40198459431679, Lot Number: 25IBG995; Medline Kit Number/SKU DYNJ86657A, UDI/DI each 10198459431678, UDI/DI case 40198459431679, Lot Number: 25GBW704; Medline Kit Number/SKU DYNJT3270, UDI/DI each 10198459322235, UDI/DI case 40198459322236, Lot Number: 26AMF231; Medline Kit Number/SKU DYNJT3270, UDI/DI each 10198459322235, UDI/DI case 40198459322236, Lot Number: 25GMC304.
- Units affected
- 413 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-2013-2026
- 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