Ritmed Neurological Sponges — Class II medical device recall Z-2459-2026
Ongoing recall by AMD Medicom Inc., reported 2026-06-24, distributed in CA, IL, MT, NC, OH, RI, TN, TX…. Neurological sponges used to moisten or absorb biological fluid during neurological surgery and may also be us
| Recall number | Z-2459-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | AMD Medicom Inc., Montreal, Canada |
| Recall initiated | 2026-05-08 |
| Classified | 2026-06-16 |
| Reported by FDA | 2026-06-24 |
| Distributed | CA, IL, MT, NC, OH, RI, TN, TX, VA |
| Quantity | 10 |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 10686864044465 |
| Lot numbers | 17936 |
| Model numbers | 85995C |
Product
Ritmed Neurological Sponges, 0.75x0.75in, Sterile, REF: 85995C
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2459-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.