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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 79398

5 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
February 08, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Bovie Medical Corporation

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

5 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 5

J-Plasma Precise(R) OPEN, Catalog Numbers: BVX-044-BPP, BVX-044-BPS, BVX-150-BPP, BVX-150-BPS

Z-1153-2018
Recall number
Z-1153-2018
Initiated
February 08, 2018
Classification
Class II
Status
Terminated
Recalling firm
Bovie Medical Corporation
Quantity
1005 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

All lots manufactured since 01/01/2014

Distribution pattern

worldwide

device · product 2 of 5

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

Z-1154-2018
Recall number
Z-1154-2018
Initiated
February 08, 2018
Classification
Class II
Status
Terminated
Recalling firm
Bovie Medical Corporation
Quantity
6906 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

All lots manufactured since 01/01/2014

Distribution pattern

worldwide

device · product 3 of 5

J-Plasma(R) Handpiece, Catalog Numbers: GS-018C, GS-270C, BVX-270B

Z-1155-2018
Recall number
Z-1155-2018
Initiated
February 08, 2018
Classification
Class II
Status
Terminated
Recalling firm
Bovie Medical Corporation
Quantity
5416 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

All lots manufactured since 01/01/2014

Distribution pattern

worldwide

device · product 4 of 5

J-Plasma Precise 360(R), Catalog Numbers: BVX-330BR, BVX-330NR, BVX-450BR, BVX-450NR

Z-1156-2018
Recall number
Z-1156-2018
Initiated
February 08, 2018
Classification
Class II
Status
Terminated
Recalling firm
Bovie Medical Corporation
Quantity
595 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

All lots manufactured since 01/01/2014

Distribution pattern

worldwide

device · product 5 of 5

J-Plasma Precise(R) FLEX, Catalog Number: BVX-500BF

Z-1157-2018
Recall number
Z-1157-2018
Initiated
February 08, 2018
Classification
Class II
Status
Terminated
Recalling firm
Bovie Medical Corporation
Quantity
12 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

All lots manufactured since 01/01/2014

Distribution pattern

worldwide

Field note

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