Ritmed Neurological Sponges, 0.75x0.75in, Sterile, REF: 85995C
FDA Recall Z-2459-2026 · Posted 2026-06-16
Recalling FirmAMD Medicom Inc.
Recall StatusOpen, Classified
Product CodeEFQ
Date Initiated2026-05-08
Product Quantity10
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.
Firm 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 [email protected]
On 6/5/2026, recall notices with all affected lots were emailed to customers.
Root Cause
Material/Component Contamination
Distribution Pattern
US: MT, NC, VA, CA, TX, OH, TN, IL, RI
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.