Agency classClass IIOur severity:Moderate FDA (Devices)·Z-3035-2026·Announced 2026-09-02

Olympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling

Olympus is recalling 335 PowerSeal 5 mm Sealer & Divider devices because the outer shelf box is incorrectly labeled as a 37-cm device.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error that could lead to the use of the wrong device size, but no injuries or illnesses are reported in the source text.

Plain-English summary

Olympus Corporation of the Americas is recalling 335 units of the POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Double Action. The recall is due to a potential labeling deficiency where the outer shelf box is incorrectly labeled as a 37-cm device, despite the actual device being 23 cm long.

The affected devices are identified by Model Number PS-0523CJDA, UDI-DI 00821925044531, and Lot Number FR490902. The products were distributed worldwide, including in the United States (specifically Kansas and Florida), Australia, the European Union, and Japan.

Healthcare providers and facilities should check their inventory for this specific lot and model number. If the device is found, it should be removed from use and returned to Olympus in accordance with their recall instructions. This recall is classified as Class II by the FDA.

The recalled product

Product: POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Double Action. GEI / Electrosurgical, cutting & coagulation & accessories
Manufacturer: Olympus Corporation of the Americas
Category: Medical Device — Electrosurgical Instrument
Hazard: mis-labeling
Affected units: 335

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

Model Number: PS-0523CJDA. UDI-DI: 00821925044531. Lot Number: FR490902.

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Same manufacturer · Olympus Corporation of the Americas

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