Agency classClass IIOur severity:High FDA (Devices)·Z-2629-2017·Announced 2017-07-05

Olympus Recalls High Frequency Resection Electrodes Due to Wire Breakage

Olympus Corporation of the Americas is recalling 1,264 High Frequency Resection Electrodes because loop wires may break at the distal end.

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: The recall is classified as FDA Class II, and the hazard involves a structural defect in a medical device used for diagnosis and treatment, representing a risk of harm where injury has not yet been reported.

Plain-English summary

Olympus Corporation of the Americas is recalling 1,264 units of High Frequency Resection Electrodes, endoscope, ac-powered and accessories. The affected products include Model A22201C and Model WA22037C, which are used for endoscopic diagnosis and treatment in urological and gynecological applications. The recall covers specific lot numbers distributed nationwide.

The recall was initiated because loop wires may break at the distal end of the Monopolar HF Resection Electrodes. This defect could compromise the device's function during medical procedures.

Healthcare facilities and users should stop using the affected devices and contact Olympus Corporation of the Americas for instructions on how to return or replace the products.

The recalled product

Product: High Frequency Resection Electrodes, endoscope, ac-powered and accessories The electrodes are used for endoscopic diagnosis and treatment in urological and gynecological applications.
Manufacturer: Olympus Corporation of the Americas
Category: Medical Device — Endoscopic Electrodes
Hazard: structural-defect
device-failure
Affected units: 1,264

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 (20)

Model: A22201C - Resection electrode
loop style Lot # 16123P03L001
16124P03L001
16131P03L001
16139P03L001
16140P03L001
16144P03L001
16144P03L002
16144P03L003
16155P03L001
16169P03L001
16173P03L001
16174P03L001 16174P03L002
16223P03L001
16224P03L001
16236P03L001 P16X0001
P16X0002
P16X0003
P16X0004
P16Y0001

Distribution

Distributed nationwide across the United States.

Same manufacturer · Olympus Corporation of the Americas

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