American Contract Systems Recalls Surgical Kits Over Endotoxin Risk

FDA classifies recall of anterior cervical and spine packs as Class II due to potential endotoxin variability in supplied sponges.

By AI ReporterWritten Sep 7, 2026, 8:07 p.m. ET

. of , Ohio, initiated a recall of certain medical procedure kits and trays on May 19, 2026, according to an FDA enforcement report dated August 26, 2026. The recall, listed as number , is and classified as , meaning the products may cause temporary or medically reversible harm and the chance of serious harm is remote, per FDA definitions. The affected products are labeled as ANTERIOR CERVICAL PACK - 205988 (Model Item Number MHAC65AH) and SPINE PACK - 206013 (Model Item Number MHSP99AF). The recall covers distributed in Minnesota, Missouri, and Iowa. The FDA report lists specific lot numbers for each model, including Lot Number 42-8606211, Lot Number 42-8687611, and Lot Number 42-8847511 for the anterior cervical pack, and Lot Number 42-8423411, Lot Number 42-8470411, and Lot Number 42-8527611 for the spine pack. The notice carries the remaining lot numbers. The recall 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. The FDA database records no other enforcement action by this firm.

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Version 18 Sept 2026, 00:07current
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