- Recalling firm
- AMD Medicom Inc.
- Reason for recall
- Neurological sponges used to moisten or absorb biological fluid during neurological surgery and may also be used to protect the brain during incision, may not consistently meet endotoxin specification for devices that contact the cerebrospinal fluid. Elevated endotoxin levels may lead to neurovascular adverse events, febrile response, and/or local transient inflammation, hypotension, or nausea.
- Affected products (lot / model / serial)
- UDI-DI: 10686864044465, Lot: 17936
- Units affected
- 10
- Distribution pattern
- US: MT, NC, VA, CA, TX, OH, TN, IL, RI
- Firm location
- Montreal, Canada
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2459-2026
- Recall initiated
- May 8, 2026
- FDA classification date
- June 16, 2026
- FDA report date
- June 24, 2026
- FDA event ID
- 99006
- Last updated on HTM Vibe
- July 23, 2026