Official recall record
Ritmed Neurological Sponges, Description/REF: 0.5x0.5in, Non-Sterile/55992C; 0.5x1.0in, Non-Sterile/55993C; 0.5x3.0in, Non-Sterile/559
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2026-05-08
- Country of alert
- Canada
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 20686864043205
- Brand on record
- AMD Medicom Inc.
- Product category
- Medical Device
What the authority reported
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.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-09-16.
Record last checked against the registry on 2026-09-16.
Other recalls from this brand
- 2026-05-08 · US FDA — Medical Devices
Ritmed Neurological Sponges, 0.75x0.75in, Sterile, REF: 85995C
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