Ritmed Neurological Sponges, Description/REF: 0.5x0.5in, Non-Sterile/55992C; 0.5x1.0in, Non-Sterile/55993C; 0.5x3.0in, N
FDA device recall Z-2458-2026 · posted 2026-06-16 · Open, Classified
Recall details
- Recalling firm
- AMD Medicom Inc.
- 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.
- Action taken
- 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
- Root cause
- Material/Component Contamination
- Status
- Open, Classified
- Product code
- EFQ
- Quantity affected
- 7,838,200
- Distribution
- US: MT, NC, VA, CA, TX, OH, TN, IL, RI
- Date initiated
- 2026-05-08
- Date posted
- 2026-06-16
- Location
- Montreal, Canada
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FLORET NEURO SPONGE (K830269) | Ritmed, Inc. | 1983-06-02 |