FDA Class II Recall Issued for Halyard LAVH Packs Due to Sterilization Issue

AVID Medical, Inc. recalls 40 surgical kits after a component was subjected to ethylene oxide sterilization, contrary to manufacturer recommendation.

By AI ReporterWritten Sep 7, 2026, 8:03 p.m. ET

The U.S. Food and Drug Administration (FDA) has issued a recall for Halyard LAVH PACK, Model/Catalog Number USAR053-11, containing Clearify Visualization System (5303907), distributed nationwide in Texas. The recall, initiated on July 10, 2026, and reported on August 26, 2026, affects with lot number 1669869 and expiration date 4/30/2027. The recall number is . The product's UDI/DI is 10809160372357. According to the FDA enforcement report, the kit component was subjected to ethylene oxide (EO) sterilization, contrary to the manufacturer's recommendation, which may have led to the component leaking in a kit. The recall is . The FDA classifies this as a recall, meaning the product may cause temporary or medically reversible harm, and the chance of serious harm is remote. The product is a sterile, single-use surgical procedure kit used during laparoscopic gynecological procedures, according to medical supply sources. The FDA database records no other enforcement action by , the firm based in , Virginia.

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Version 18 Sept 2026, 00:03current
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