American Contract Systems surgical procedure kits recalled for endotoxin variability in sponges
What this means
American Contract Systems medical procedure kits containing Ritmed Neurological Sponges may have inconsistent endotoxin levels. Endotoxins are bacterial substances that can cause serious reactions if they contaminate sterile surgical sites. The recall affects nine specific kit models across multiple lot numbers.
- Check if your facility has any of the affected kit models listed in the recall
- Quarantine and do not use any kits matching the recalled lot numbers
- Contact American Contract Systems or your supplier for return or replacement instructions
- Review patient records if these kits were already used and contact your local health department if needed
The agency's original wording
The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected variability of endotoxin levels on the products.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2989-2026More American Contract Systems recalls
- FDA-Device2026-09-02American Contract Systems Convenience Kits recalled for catheter performance specification failure
- FDA-Device2026-09-02American Contract Systems Convenience Kit recalled for catheter performance failure
- FDA-Device2026-09-02American Contract Systems Convenience Kit recalled for catheters not meeting performance specifications
- FDA-Device2026-09-02American Contract Systems Convenience Kit recalled for catheter performance defect
- FDA-Device2026-08-26American Contract Systems surgical kits recalled for endotoxin variability in sponges
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