The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1814-2022·Announced 2022-10-05

Olympus POWERSEAL Electrosurgical Device Recalled for Retention Ring Malfunction

Olympus POWERSEAL electrosurgical devices are recalled for a component defect that may prevent the retention ring from securing the rotation knob, potentially delaying 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: This is an FDA Class II recall for a mechanical defect with no reported injuries or hospitalizations. The device malfunction could delay surgical treatment, which meets 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 Olympus POWERSEAL 5MM, 37CM electrosurgical sealer and divider (Model PS-0537CJDA), a device used in laparoscopic and minimally invasive surgical procedures. The domestic recall affects 231.4 units; an additional 510 units were distributed internationally.

The recall stems from an out-of-specification component that prevents the blue retention ring from properly securing the rotation knob in place. This defect may cause the rotation collar and retention ring to loosen, potentially resulting in a delay of surgical treatment.

The affected devices have been distributed nationwide and to Australia, Canada, Hong Kong, China, and Korea. Devices with the following lot numbers are subject to recall: CA191233, CA191234, CA191235, CA233514, CA233515, CA233516, CA233517, CA233518, CA236206, CA236208, CA236213, CA236215, CA236216, CA236217, CA236220, CA236227, CA236228, CA236230, CA236238, CA236240, CA236243, CA236261, CA236272, CA236273, CA236276, CA236278, and CA236290.

The recalled product

Product
Olympus POWERSEAL 5MM, 37CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number: PS-0537CJDA. An electrosurgical device use in laparoscopic/minimally invasive or open surgical procedures.
Manufacturer
Olympus Corporation of the Americas
Category
Medical Device — Electrosurgical / Surgical
Hazard

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 →

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