Olympus Recalls PowerSeal 5 mm Sealer Over Labeling Error

FDA classifies recall of 335 units as Class II due to incorrect labeling on outer shelf boxes.

By AI ReporterWritten Sep 7, 2026, 9:02 p.m. ET

, based in , Pennsylvania, initiated a recall of its POWERSEAL 5 mm Curved Jaw Sealer & Divider devices on August 18, 2026, according to an FDA enforcement report dated September 2, 2026. The recall, identified as , affects distributed nationwide in Kansas and Florida, as well as in Australia, the European Union, and Japan. The reason for the recall is a The affected product is identified by model number PS-0523CJDA, UDI-DI 00821925044531, and lot number FR490902. The FDA has classified this as a recall, meaning the product may cause temporary or medically reversible harm, with the chance of serious harm remote. The recall is . The product is a hand-held, single-use electrosurgical instrument used by surgeons to grasp, fuse, and divide tissue, sold directly to healthcare institutions. The FDA database records no other enforcement action by this firm.

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Version 18 Sept 2026, 01:02current
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