Quality & complianceOfficial

Olympus recalls further reusable HF-cable models in Canada after earlier WA00014A recall

🇨🇦 Health Canada · Thu 05 Nov 2026

Health Canada has published a Type II recall covering reusable monopolar and bipolar HF-cables from Olympus Winter & Ibe, with a reminder on service-life instructions.

Health Canada has published a recall notice for reusable HF-cables made by Olympus Winter & Ibe GmbH of Hamburg, Germany. The notice, reference RA-82911, was posted on 5 November 2026. The recall date is given as 16 October 2026, and the issue is classed as a medical device performance problem.

The action follows an earlier medical device recall for model WA00014A. Olympus has since identified 19 additional models that may experience the same failure. The notice does not describe the failure itself. The published table lists 14 model numbers: nine monopolar HF-cables (A00010A, A00011A, A00012A, A0335.1, A0355, A0358, A0391, A0392 and A0393), two bipolar HF-cables (A60000C and A60003C), two non-sterile, reusable Versapoint II connector cable plugs (WA47784A and WA47785A) and one HF-cable, WA00013A.

Olympus is reminding customers of the instructions and caution on service life in the HF-cable instructions for use (IFU). The company's stated aim is to reduce the likelihood of cable failure. For every listed model, the notice says more than 10 lot or serial numbers are affected and tells users to contact the manufacturer for them.

Health Canada classes the recall as Type II. In general, that class covers situations where use of a product may cause temporary or medically reversible adverse effects, or where the likelihood of serious harm is remote. The notice is aimed at healthcare audiences and lists the affected devices under general and plastic surgery and dental. It advises contacting the manufacturer for more information.

What it means for your team

  • Facilities using Olympus reusable HF-cables should check their inventory against the listed model numbers and ask the manufacturer for the affected lot and serial numbers.
  • Quality and device-reprocessing teams should review how cable service life is tracked and whether it matches the IFU instructions that Olympus is highlighting.
  • The notice cites 19 additional models but lists only 14 model numbers, so regulatory teams may want to confirm the full scope with Olympus.
  • Teams with Canadian exposure should link this recall (RA-82911) to the earlier WA00014A recall in their recall and field-safety records.

Official source: Health Canada ↗

Article written by VigiEye from the official source (Health Canada). AI-assisted; check the source before acting.

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