The Recall Desk
HighFDA (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.

What this means for you

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
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.

Related recalls

Same manufacturer · Olympus Corporation of the Americas

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Same hazard · structural defect

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