FDA Device recall Z-2459-2026
Ritmed Neurological Sponges, 0.75x0.75in, Sterile, REF: 85995C
- FDA Device
- Class II
- ongoing
- Published 2026-06-24
On 2026-06-24 the FDA classified a Class II recall of Ritmed Neurological Sponges, 0.75x0.75in, Sterile, REF: 85995C by Amd Medicom, citing 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 en….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2459-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-05-08 |
| Published | 2026-06-24 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Amd Medicom |
| Distribution | CA, IL, MT, NC, OH, RI, TN, TX, VA |
Product
Ritmed Neurological Sponges, 0.75x0.75in, Sterile, REF: 85995C
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.
Identifiers
| code_info | UDI-DI: 10686864044465, Lot: 17936 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2459-2026%22
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