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Recall Observatory FDA recall evidence

Device product

Ritmed Neurological Sponges, 0.75x0.75in, Sterile, REF: 85995C

Z-2459-2026

May 08, 2026

Class II

Product summary

Firm
AMD Medicom Inc.
Event
Event 99006
Status
Ongoing
Classification
Class II
Quantity
10
Official record key
device-enforcement:Z-2459-2026

Official wording

Reason: 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.

Code information: UDI-DI: 10686864044465, Lot: 17936

Distribution pattern: US: MT, NC, VA, CA, TX, OH, TN, IL, RI

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.