CLASS II Device recall · Reported 11 Jun 2014 · FDA Enforcement Report

Macrolyte Premie Dispersive Electrode recalled by ConMed

ConMed is recalling Macrolyte Premie Dispersive Electrode, distributed nationwide in the US. The recall was initiated on 8 May 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesBeginning Lot Code 1204275; Ending Lot Code 1401075 (Lot code indicates the date of manufacture = yymmdds, where s is the shift).

Quantity recalledDomestic - 12,600 units, Foreign - 44,280 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-1719-2014
FDA event ID: 68193
Recalling firm: ConMed, Utica, NY
Classification: Class II
Status: Terminated
Recall initiated: 8 May 2014
FDA classified: 4 Jun 2014
Reported: 11 Jun 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Surgical Instruments

Timeline

8 May 2014	Recall initiated by company
4 Jun 2014	Classified by FDA	+27 days
11 Jun 2014	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

ConMed Corporation has received complaints regarding sparking, no output and burning at the cord set connection. The complaints have been confirmed by ConMed.

Product as listed by the FDA

MACROLYTE Premie Dispersive Electrode, REF 440-2400, CONMED CORPORATION. The device is applied to the patient during electrosurgical procedures to provide a path for RF current to leave the patient and return to the generator.

Where it was distributed

Worldwide Distribution - USA (nationwide) and the countries of Australia, Belgium, Brazil, Canada, Ecuador, El Salvador, Finland, France, Great Britain, Honduras, India, Indonesia, Israel, Italy, Japan, Latvia, Lebanon, Malaysia, Mexico, Panama, Philippines, Portugal, Saudi Arabia, South Africa, Spain, Thailand, Trinidad, United Arab Emirates and Uruguay.

Nationwide

Questions about this recall

Is Macrolyte Premie Dispersive Electrode recalled?

Yes. ConMed recalled Macrolyte Premie Dispersive Electrode on 8 May 2014. The recall is Class II and its status is Terminated. Recall number Z-1719-2014.

Why was it recalled?

ConMed Corporation has received complaints regarding sparking, no output and burning at the cord set connection. The complaints have been confirmed by ConMed.

Which lots are affected?

Beginning Lot Code 1204275; Ending Lot Code 1401075 (Lot code indicates the date of manufacture = yymmdds, where s is the shift).

Where was it sold?

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.

More recalls from ConMed

All 92

Reported	Class	Recall	Company	Reason	Where
2 Sep 2026Device	CLASS II	Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled	ConMed	Sterility	Nationwide
24 Jun 2026Device	CLASS II	AirSeal Access Port and Palm Grip Obturator recalled by ConMed	ConMed	Packaging Defects	Nationwide
24 Jun 2026Device	CLASS II	AirSeal Access Port and Obturator with Blunt Tip Length recalled	ConMed	Packaging Defects	Nationwide
24 Jun 2026Device	CLASS II	AirSeal Access Port and Low Profile Obturator recalled by ConMed	ConMed	Packaging Defects	Nationwide
24 Jun 2026Device	CLASS II	AirSeal Access Port and Low Profile Obturator recalled by ConMed	ConMed	Packaging Defects	Nationwide

Other Surgical Instruments recalls

All 3,809

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Medline Convenience Kits: IV Start KIT recalled by Medline Industries	Medline Industries	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits containing BD ChloraPrep Clear recalled	Medline Industries	Lead & Heavy Metals	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled	ConMed	Sterility	Nationwide