Changeflow GovPing Pharma & Drug Safety Olympus HF Cable Recall
Urgent Enforcement Removed Final

Olympus HF Cable Recall

Favicon for recalls-rappels.canada.ca Health Canada Recalls & Safety Alerts
Filed March 24th, 2026
Detected March 25th, 2026
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Summary

Health Canada has issued a Type II recall for the Olympus HF Cable (Model WA00014A) due to performance issues leading to insulation wear, corrosion, and failure. The recall follows 109 complaints, including 17 reports of minor burns, though no serious injuries were reported.

What changed

Health Canada has issued a Type II recall for the Olympus HF Cable, model WA00014A. The recall was initiated following 109 complaints, 17 of which involved minor burns, stemming from the device's use beyond its service life, leading to insulation wear, corrosion, and failure. The manufacturer, Olympus Winter & Ibe GmbH, is involved in this action.

Healthcare providers using this device should contact the manufacturer for additional information and to understand the implications of the recall. While no serious injuries have been reported, the potential for burns necessitates careful review of device usage and maintenance protocols to prevent further incidents.

What to do next

  1. Contact the manufacturer for additional information regarding the Olympus HF Cable recall.
  2. Review device usage and maintenance protocols to ensure compliance with service life guidelines.

Source document (simplified)

Health product recall

Olympus HF Cable

Brand(s)

Olympus Winter & Ibe GmbH

Last updated

2026-03-24

Summary

Product Olympus HF Cable Issue Medical devices - Performance What to do

Contact the manufacturer if you require additional information.

Audience Healthcare

Affected products

| Affected products | Lot or serial number | Model or catalogue number |
| --- | --- | --- |
| HF Cable | More than 10 numbers, contact manufacturer. | WA00014A |

Issue

Olympus received a complaint involving a thermal event with an HF cable during a procedure, causing a user burn. Investigation showed the device was used beyond IFU-defined service life, leading to insulation wear, corrosion, and failure. A four-year review identified 109 complaints, with no serious injuries and 17 minor burns.

Additional information

Details

Original published date:

2026-03-24

Alert / recall type Health product recall Category Health products - Medical devices - Gastroenterology and urology Companies Olympus Winter & Ibe GmbH

Kuehnstrasse 61, Hamburg, Hamburg, Germany, 22045

Published by Health Canada Audience Healthcare Recall class Type II Recall date

2026-03-24

Identification number RA-81789

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Classification

Agency
Health Canada
Filed
March 24th, 2026
Instrument
Enforcement
Legal weight
Binding
Stage
Final
Change scope
Substantive
Document ID
RA-81789

Who this affects

Applies to
Healthcare providers Medical device makers
Industry sector
3345 Medical Device Manufacturing
Activity scope
Medical Device Performance Product Safety
Geographic scope
Canada CA

Taxonomy

Primary area
Medical Devices
Operational domain
Compliance
Topics
Product Safety Healthcare Compliance

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