AMD Medicom Ritmed Neurological Sponges Recall: Endotoxin Risk in Surgery
AMD Medicom recalls Ritmed Neurological Sponges (0.5x0.5in to 1.0x3.0in) due to potential endotoxin levels that could cause neurovascular issues during surgery. Affected lots distributed after May 2022.
Use caution until it’s fixed
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.
Contact the company
What happened, in plain English
AMD Medicom is recalling Ritmed Neurological Sponges that may not meet endotoxin safety standards for brain surgery. This could lead to serious complications like inflammation or low blood pressure if used improperly. Read more at govinfonow.com/recall/49198-amd-medicom-ritmed-neurological-sponges-recall-endotoxin-risk-in-surgery.
Source Summary by GovInfoNow · govinfonow.com/recall/49198-amd-medicom-ritmed-neurological-sponges-recall-endotoxin-risk-in-surgery · Updated August 10, 2026 · FDA enforcement record: FDA #Z-2458-2026
Cite this page
“AMD Medicom Ritmed Neurological Sponges Recall: Endotoxin Risk in Surgery.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/49198-amd-medicom-ritmed-neurological-sponges-recall-endotoxin-risk-in-surgery. Based on FDA recall #Z-2458-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2458-2026%22&limit=1).
Why it’s dangerous
These sponges may contain elevated endotoxin levels when used near cerebrospinal fluid. Endotoxins can trigger inflammation, fever, low blood pressure, or nausea in sensitive patients during surgery.
Who’s affected
Surgical teams and hospitals using these sponges for brain procedures are most at risk. Patients undergoing neurosurgery with these sponges could experience adverse reactions.
How to tell if you have this one
Check for sponges labeled 0.5x0.5in, 0.5x1.0in, 0.5x3.0in, 0.75x0.75in, 1.0x1.0in, 1.0x3.0in, or 0.5x1.5in with model numbers 55992C-55998C. They were distributed after May 1, 2022, with specific lot numbers listed in the recall.
- Brand
AMD Medicom- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
US: MT, NC, VA, CA, TX, OH, TN, IL, RI
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-2458-2026 | Ritmed Neurological Sponges, Description/REF: 0.5x0.5in, Non-Sterile/55992C; 0.5x1.0in, Non-Sterile/55993C; 0.5x3.0in, Non-Sterile/55994C; 0.75x0.75in, Non-Sterile/55995C; 1.0x1.0in, Non-Sterile/55996C; 1.0x3.0in, Non-Sterile/55997C; 0.5x1.5in, Non-Sterile/55998C; UDI-DI: 20686864043205. Distributed After May 1st, 2022, including the following lots: 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 | 7,838,200 |
| Z-2459-2026 | Ritmed Neurological Sponges, 0.75x0.75in, Sterile, REF: 85995C; UDI-DI: 10686864044465, Lot: 17936 | 10 |
What to do — step by step
Check Product Details
Identify the sponge size and model number to confirm if it matches the recalled items listed in the recall notice.
Contact Manufacturer
Reach out to AMD Medicom for guidance on next steps if you have the recalled sponges.
Where it went and when
Where it was distributed
Distributed in 9 states.
FDA distribution: “US: MT, NC, VA, CA, TX, OH, TN, IL, RI” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Illinois, Montana, North Carolina, Ohio, Rhode Island, Tennessee, Texas, Virginia.
Recall timeline
FDA published this recall 47 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2458-2026 (May 8, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2458-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.