FDA DevicesClass II
Ritmed Neurological Sponges, 0.75x0.75in, Sterile, REF: 85995C
Published: June 24, 2026Recall ID: Z-2459-2026Category: devicesCountry: US
Reason for Recall / Hazard
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.
Product Description & Identification
Ritmed Neurological Sponges, 0.75x0.75in, Sterile, REF: 85995C
Additional Source Details
| Field | Value |
|---|---|
| City | Montreal |
| Event id | 99006 |
| Address 1 | 2555 Ch de L'Aviation |
| Code info | UDI-DI: 10686864044465, Lot: 17936 |
| Postal code | N/A |
| Report date | 20260624 |
| Product type | Devices |
| Product quantity | 10 |
| 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260508 |
| Initial firm notification | Letter |
| Center classification date | 20260616 |
Overview
- Recalling FirmAMD Medicom Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionUS: MT, NC, VA, CA, TX, OH, TN, IL, RI