CLASS II Device recall · Reported 28 Mar 2018 · FDA Enforcement Report

J-Plasma Precise(R) recalled by Bovie Medical

Bovie Medical is recalling J-Plasma Precise(R). The recall was initiated on 8 Feb 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll lots manufactured since 01/01/2014

Quantity recalled6906 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-1154-2018
FDA event ID: 79398
Recalling firm: Bovie Medical, Clearwater, FL
Classification: Class II
Status: Terminated
Recall initiated: 8 Feb 2018
FDA classified: 21 Mar 2018
Reported: 28 Mar 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

8 Feb 2018	Recall initiated by company
21 Mar 2018	Classified by FDA	+41 days
28 Mar 2018	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

Bovie Medical is issuing a correction to address incomplete insertion of the J-Plasma(R) handpiece cable plug into the generator receptacle resulting in an incomplete helium seal. The potential exists for patient fluid backflow into the handpiece and the generator receptacle leading to risk of cross-contamination if the generator is reused.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

J-Plasma Precise(R), Catalog Numbers: BVX-150B, BVX-150N, BVX-330B, BVX- 330N, BVX-450B, BVX-450N

Where it was distributed

worldwide

Questions about this recall

Is J-Plasma Precise(R) recalled?

Yes. Bovie Medical recalled J-Plasma Precise(R) on 8 Feb 2018. The recall is Class II and its status is Terminated. Recall number Z-1154-2018.

Why was it recalled?

Which lots are affected?

All lots manufactured since 01/01/2014

Where was it sold?

worldwide

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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