CLASS II Device recall · Reported 27 Feb 2013 · FDA Enforcement Report

Electrolase Hyfrecator(r) Electrodes - Sharp recalled by ConMed

ConMed is recalling Electrolase Hyfrecator(r) Electrodes - Sharp, distributed nationwide in the US. The recall was initiated on 28 Jan 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesBeginning Lot Code 120628X, Ending Lot Code 120917X. [Lot codes on boxes and packaging contain a lot code in the following format: 120917X where 12 represents the year (2012), 09 represents the month (September), 17 represents the day of the month, and X represents the manufacturing shift code (1, 2, 3, 4,5,6 or 9)].

Quantity recalledDomestic Distribution: 97,450 units; Foreign Distribution: 6,800 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-0826-2013
FDA event ID: 64248
Recalling firm: ConMed, Utica, NY
Classification: Class II
Status: Terminated
Recall initiated: 28 Jan 2013
FDA classified: 15 Feb 2013
Reported: 27 Feb 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Other Medical Devices

Timeline

28 Jan 2013	Recall initiated by company
15 Feb 2013	Classified by FDA	+18 days
27 Feb 2013	Published in enforcement report	+12 days

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

Reason for recall

Some devices had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

ELECTROLASE HYFRECATOR(R) ELECTRODES - SHARP, REF/Catalog Number 7-100-8BX, Disposable Hyfrecator(R) Tips, Sterile, Rx Only --- CONMED CORPORATION USA. Intended to be used as active RF electrodes for desiccation, fulguration and coagulation.

Where it was distributed

Worldwide Distribution-USA (nationwide) and the countries of China, Dubai and Indonesia.

Nationwide

Questions about this recall

Is Electrolase Hyfrecator(r) Electrodes - Sharp recalled?

Yes. ConMed recalled Electrolase Hyfrecator(r) Electrodes - Sharp on 28 Jan 2013. The recall is Class II and its status is Terminated. Recall number Z-0826-2013.

Why was it recalled?

Some devices had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products.

Which lots are affected?

Beginning Lot Code 120628X, Ending Lot Code 120917X. [Lot codes on boxes and packaging contain a lot code in the following format: 120917X where 12 represents the year (2012), 09 represents the month (September), 17 represents the day of the month, and X represents the manufacturing shift code (1, 2, 3, 4,5,6 or 9)].

Where was it sold?

Worldwide Distribution-USA (nationwide) and the countries of China, Dubai and Indonesia.

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 21 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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