CLASS II Device recall · Reported 21 Dec 2016 · FDA Enforcement Report

HF Cable WA00014A, Endoscopic electrosurgical unit and accessories recalled

Olympus Corporation of the Americas is recalling HF Cable WA00014A, Endoscopic electrosurgical unit and accessories, distributed nationwide in the US. The recall was initiated on 3 Nov 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel Number: WA00014A Lot Numbers: 158W, 159W, 15XW, 15YW, 15ZW, 161W, 162W, 163W, 164W, 165W, 166W, 167W

Quantity recalled494 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0754-2017
FDA event ID: 75601
Recalling firm: Olympus Corporation of the Americas, Center Valley, PA
Classification: Class II
Status: Terminated
Recall initiated: 3 Nov 2016
FDA classified: 14 Dec 2016
Reported: 21 Dec 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Surgical Instruments

Timeline

3 Nov 2016	Recall initiated by company
14 Dec 2016	Classified by FDA	+41 days
21 Dec 2016	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Software malfunction that results in incorrect generation or display of error codes.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

HF Cable WA00014A, Endoscopic electrosurgical unit and accessories

Where it was distributed

Distributed Nationwide

Nationwide

Questions about this recall

Why was it recalled?

Software malfunction that results in incorrect generation or display of error codes.

Which lots are affected?

Model Number: WA00014A Lot Numbers: 158W, 159W, 15XW, 15YW, 15ZW, 161W, 162W, 163W, 164W, 165W, 166W, 167W

Where was it sold?

Distributed Nationwide

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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