Recall Z-2459-2026 ยท EFQ Gauze/Sponge, Internal
AMD Medicom Inc.
Ritmed Neurological Sponges, 0.75x0.75in, Sterile, REF: 85995C
| Date | Jun 16, 2026 (initiated May 8, 2026) |
| Status | Open, Classified |
| 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. |
| Root cause | Material/Component Contamination |
| Action | On 5/8/2026, recall notices were emailed to customers who were asked to do the following: 1) Discontinue use, quarantine and destroy affected devices. 2) Notify any customers or facilities to whom you have distributed this product. 3) Complete and return the response form via email to firm's customer service at Claims@medicom.ca On 6/5/2026, recall notices with all affected lots were emailed to customers. |
| Quantity | 10 |
| Distribution | US: MT, NC, VA, CA, TX, OH, TN, IL, RI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K830269 | FLORET NEURO SPONGE Ritmed, Inc., Jun 2, 1983 |