Agency classClass IIOur severity:High FDA (Devices)·Z-1813-2022·Announced 2022-10-05

Olympus POWERSEAL surgical sealer recalled for loose retention ring defect

Olympus Corporation is recalling certain POWERSEAL electrosurgical sealers due to an out-of-specification component that may allow the retention ring to loosen, potentially delaying surgical treatment.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall of a medical device with a mechanical component defect. No adverse events, injuries, or hospitalizations have been reported. However, the defect poses a risk of treatment delay in a surgical context, meeting the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Olympus Corporation of the Americas is recalling the POWERSEAL 5MM, 23CM CURVED JAW SEALER & DIVIDER (Model PS-0523CJDA), an electrosurgical device used in laparoscopic and minimally invasive surgical procedures.

The recall is due to an out-of-specification component that prevents the blue retention ring from keeping the rotation knob in place. This defect may result in a loose rotation collar and retention ring, which could potentially delay treatment during surgical procedures.

The recall affects 27 units distributed in the United States and 83 units distributed overseas (Australia, Canada, Hong Kong, China, and Korea). Affected lot numbers are CA191167, CA191168, CA191169, and CA191170.

Healthcare facilities and surgical teams using affected units should discontinue use immediately and contact Olympus Corporation of the Americas for replacement or additional instructions.

The recalled product

Product: Olympus POWERSEAL 5MM, 23CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number: PS-0523CJDA. An electrosurgical device use in laparoscopic/minimally invasive or open surgical procedures.
Manufacturer: Olympus Corporation of the Americas
Category: Medical Device — Electrosurgical device
Hazard: mechanical-defect
loose-parts
treatment-delay

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)

UDI-DI: 00821925044531 Lot Numbers: CA191167 CA191168 CA191169 CA191170

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Olympus Corporation of the Americas under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Same manufacturer · Olympus Corporation of the Americas

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