Ritmed Neurological Sponges
AMD Medicom recalls Ritmed Neurological Sponges due to elevated endotoxin risk; full REF list on FDA page.
Stop using the recalled Ritmed Neurological Sponges immediately. Contact AMD Medicom Inc. for instructions on returning the product and obtaining a replacement or refund.
Why it was recalled
AMD Medicom Inc. is recalling Ritmed Neurological Sponges, a family of non-sterile sponges used to moisten or absorb biological fluid during neurological surgery and to protect the brain during incision, because they may not consistently meet endotoxin specifications for devices that contact cerebrospinal fluid. Elevated endotoxin levels may lead to neurovascular adverse events, febrile response, local transient inflammation, hypotension, or nausea. The full list of affected REF codes is available on the FDA recall page.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
Ritmed Neurological Sponges
| Product | Lot code | Recall # | UDI-DI |
|---|---|---|---|
| Description/REF | 19316, 16409, 15463-7, 15463-6, 15463-5, 15463-4, 15463-3, 15463-2, 15463-1, 15463, 15192-1, 15192, 14813, 14039, 13673, 13289, 12641, 12206, 11851, 11020-1, 11020, 10586, 10392, 9243, 8160, 7784, 7748, 7044 | Z-2458-2026 | 20686864043205 |
| 0.75x0.75in, Sterile, REF: 85995C | 17936 | Z-2459-2026 | 10686864044465 |
Where it was sold
Distributed in California, Illinois, Montana, North Carolina, Ohio, Rhode Island, Tennessee, Texas, and Virginia.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Other Contamination recalls
Editorial summary by Recall Canary · summary updated 2026-08-27 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification