FDA Medical devices recall ·
Ritmed Neurological Sponges, 0.75x0.75in, Sterile recall
- Recall number
- Z-2459-2026
- Date
- (initiated May 8, 2026)
- Company / brand
- AMD Medicom Inc.
2555 Ch de L'Aviation, Montreal, Canada - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 10
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Ritmed Neurological Sponges, 0.75x0.75in, Sterile, REF: 85995C
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI: 10686864044465, Lot: 17936
Distribution
US: MT, NC, VA, CA, TX, OH, TN, IL, RI
States: California Illinois Montana North Carolina Ohio Rhode Island Tennessee Texas Virginia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2459-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.