Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1155-2021·Announced 2021-03-10

Bovie Medical Recalls ConMed Disposable Bipolar Ablators Due to Packaging Defect

Bovie Medical Corporation is recalling 5,270 ConMed Disposable Bipolar Ablators because pinholes in the sterile packaging may compromise the sterile barrier.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a potential sterile barrier breach without reported injuries or illnesses, fitting the criteria for a moderate severity recall.

Plain-English summary

Bovie Medical Corporation is recalling 5,270 units of ConMed Disposable Bipolar Ablators. These devices are intended for cutting, vaporization, and coagulation of soft tissue during arthroscopic surgical procedures. The recall involves specific catalog numbers and lots, including C3390A, C3350A, C3350NA, C2455NA, C1860NA, and C3390NA.

The recall was initiated due to a potential breach of the sterile packaging barrier. The source text indicates that pinholes may develop at the crease of the double-folded edge of the current package configuration, which could compromise the sterility of the device. The affected units were distributed nationwide in the states of California and Florida.

Healthcare providers and facilities should stop using the affected devices and contact Bovie Medical Corporation for further instructions. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violation could cause temporary or medically reversible adverse health consequences.

The recalled product

Product: ConMed Disposable Bipolar Ablators - Product Usage: intended to be used for cutting, vaporization, and coagulation of soft tissue during arthroscopic surgical procedures.
Manufacturer: Bovie Medical Corporation
Category: Medical Device — Surgical Instruments
Hazard: sterile-barrier-breach
Affected units: 5,270

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

Catalog Numbers C3390A (lots 0317F
0417B
0517B
0517D
0517J
0617D
0617F
0617H
0617K
0717A
0717G
0817B
0917G
0917J
1017C
1017E
1017J
1117B
0418C)
C3350A (lots 0317F

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 3 recalled by Bovie Medical Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Same manufacturer · Bovie Medical Corporation

See all →

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Moderate
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High
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Severe
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Severe
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FDA (Devices) · 2018-10-31

Same hazard · sterile barrier breach