Agency classClass IIOur severity:High FDA (Devices)·Z-1815-2022·Announced 2022-10-05

Olympus POWERSEAL 5MM Electrosurgical Sealer Recalled Due to Loose Retention Ring

Olympus is recalling POWERSEAL 5MM electrosurgical sealers due to a component defect that may cause the rotation knob to loosen and delay 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 device with a component defect that may result in loose components during surgical use. This is a risk-of-harm product where a functional defect could potentially delay treatment. Per the severity rubric, risk-of-harm products without reported injuries score 3 (High).

Plain-English summary

Olympus Corporation of the Americas is recalling the POWERSEAL 5MM, 44CM, Curved Jaw Sealer & Divider (Model PS-0544CJDA), an electrosurgical device used in laparoscopic, minimally invasive, and open surgical procedures.

The device contains 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 cause a delay of treatment.

This recall affects a total of 177 units: 44 units distributed nationwide and 133 units distributed to Australia, Canada, Hong Kong, China, and Korea. The affected lot numbers are CA191182, CA191183, CA191184, CA191185, CA191186, CA236235, CA236237, and FR230559. The FDA recall number is Z-1815-2022.

The recalled product

Product: Olympus POWERSEAL 5MM, 44CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number: PS-0544CJDA. An electrosurgical device use in laparoscopic/minimally invasive or open surgical procedures.
Manufacturer: Olympus Corporation of the Americas
Category: Medical Device — Electrosurgical Instruments
Hazard: component-defect
mechanical-failure
treatment-delay

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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