AMD-RITMED recallZ-2459-2026 · AMD Medicom Inc. · initiated May 8, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from AMD Medicom Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Material/Component Contamination
What the company is doing
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.
Recall details
- Recall number
- Z-2459-2026
- Status
- Open, Classified
- Initiated by the company
- May 8, 2026
- Posted by the FDA
- Jun 16, 2026
- Recalling firm
- AMD Medicom Inc.
- Quantity
- 10
- Product code
- EFQ
- FDA submissions
- K830269
- Distribution
- US: MT, NC, VA, CA, TX, OH, TN, IL, RI
Product description
Ritmed Neurological Sponges, 0.75x0.75in, Sterile, REF: 85995C
Code information (models, lots, serial numbers)
UDI-DI: 10686864044465, Lot: 17936
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- AMD-RITMED 85995CAMD Medicom Inc · GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE1 recall0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 99006).
- Z-2458-2026 · Open, ClassifiedRitmed 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; 1.0…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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