American Contract Systems surgical kits recalled for endotoxin variability in sponges
What this means
American Contract Systems medical procedure kits (Anterior Cervical Pack and Spine Pack) contain Ritmed Neurological Sponges that may have unexpected variability in endotoxin levels. Endotoxins are bacterial substances that could trigger an immune response during surgery. The recall affects 160 kits distributed in Minnesota, Missouri, and Iowa.
- Check if your facility has any of the affected kits by model number (MHAC65AH or MHSP99AF) and lot numbers listed in the recall notice.
- Do not use affected kits for surgical procedures.
- Contact American Contract Systems or your distributor for instructions on return or replacement.
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-2990-2026More 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
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