Lower risk Medical device recall · FDA · Published February 1, 2021

Bovie ConMed Disposable Bipolar Ablators Recall: Sterile Packaging Risk

Bovie Medical recalls specific ConMed Disposable Bipolar Ablators due to potential pinholes in sterile packaging that could compromise sterility during surgery.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1155-2021Medical device Bovie ›

Lower-risk recall

There can be a potential breach of the sterile packaging barrier due to the development of pinholes at the crease of the double-folded edge of the current package configuration.

Take action

Contact the company

Recalling firmBovie Medical Corporation5115 Ulmerton Rd · Clearwater, FL 33760-4004

✎ GovInfoNow plain-language explainer

Bovie Medical is recalling certain ConMed Disposable Bipolar Ablators because the packaging may develop pinholes at the folded edge, risking contamination during surgical procedures. This could lead to infections if the device is used without proper sterility. Read more at govinfonow.com/recall/63323-bovie-conmed-disposable-bipolar-ablators-recall-sterile-packaging-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/63323-bovie-conmed-disposable-bipolar-ablators-recall-sterile-packaging-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1155-2021

Cite this page

“Bovie ConMed Disposable Bipolar Ablators Recall: Sterile Packaging Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63323-bovie-conmed-disposable-bipolar-ablators-recall-sterile-packaging-risk. Based on FDA recall #Z-1155-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1155-2021%22&limit=1).

Bovie Medical Corporation voluntarily recalled ConMed Disposable Bipolar Ablators due to potential sterile packaging breaches, the FDA said on Feb. 1, 2021. The recall involves 5,270 units distributed nationwide and in California and Florida.

How to tell if you have it

Brand: Bovie
Product: ConMed Disposable Bipolar Ablators
Catalog Number C3390A (lots 0317F, 0417B, 0517B, 0517D, 0517J, 0617D, 0617F, 0617H, 0617K, 0717A, 0717G, 0817B, 0917G, 0917J, 1017C, 1017E, 1017J, 1117B, 0418C)
Catalog Number C3350A (lots 0317F, 0417B, 0517B, 0517G, 0717C, 0817D, 0917C, 0917E)
Catalog Number C3350NA (lots 0317F, 0517G, 0817F)
Catalog Number C2455NA (lots 0317F, 0517B, 0717E, 1017C, 1017E)
Catalog Number C1860NA (lots 0317F, 0517B, 0717E, 0817F, 1017G, 0418E)
Catalog Number C3390NA (lots 0317F, 0517G, 0817H, 1017J, 0418E, 0518F, 1218C)

The hazard

The sterile packaging barrier may breach due to pinholes at the crease of the double-folded edge. The FDA classified this as a Class II recall.

Context

GovInfoNow's records show Bovie Medical Corporation has three other recalls on record since Feb. 8, 2018. Other recent recalls of similar products include Medline Convenience Kits Recall: Risk of Sterile Packaging Breach (June 12, 2026) and Medline Convenience Kits Recall: Risk of Contaminated Sterile Products (Jan. 7, 2026).

How to tell if you have this one

Check for catalog numbers C3390A, C3350A, C3350NA, C2455NA, C1860NA, or C3390NA with specific production lots listed in the recall notice. These devices were sold for arthroscopic surgical procedures.

Brand
Bovie
Category
Medical device

FDA recall event · 3 products

All 3 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
US Nationwide distribution in the states of CA and FL.

Recall number	Product, codes & lots	Quantity
Z-1153-2021	Velocity Disposable Bipolar Ablators - Product Usage: intended to be used for cutting, vaporization, and coagulation of soft tissue during arthroscopic surgical procedures.; Catalog Numbers 7201 (lots 0217H, 0317J, 0417B, 0417F, 0417H, 0618K, 0718B, 0718D, 0718F, 0419J, 0519J, 0120F, 0420B, 0720K, 0720M, 0820L, 0117D, 0117F, 1020L); 7205 (lots 0217B, 0317L); 7206 (lots 0217B, 0317L); 7201-01 (lots 0920B, 0920D, 0920H); 7203 (0217F, 0317B, 0317L, 0417H).	5894 units
Z-1154-2021	HNM Disposable Bipolar Ablators - Product Usage: intended to be used for cutting, vaporization, and coagulation of soft tissue during arthroscopic surgical procedures.; Catalog Numbers HNM-31-150365 (lots 1017G, 1117B, 1217B, 0418C, 0518D, 0518H, 0618B, 0618D, 0818E, 1018J, 1018M, 1118J, 1218B, 1119B, 0420H, 0820H); HNM-31-150367 (lot 1117D); HNM-31-150368 (lot 1117D).	3862 units
Z-1155-2021	ConMed Disposable Bipolar Ablators - Product Usage: intended to be used for cutting, vaporization, and coagulation of soft tissue during arthroscopic surgical procedures.; 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, 0417B, 0517B, 0517G, 0717C, 0817D, 0917C, 0917E); C3350NA (lots 0317F, 0517G, 0817F); C2455NA (lots 0317F, 0517B, 0717E, 1017C, 1017E); C1860NA (lots 0317F, 0517B, 0717E, 0817F, 1017G, 0418E); C3390NA (lots 0317F, 0517G, 0817H, 1017J, 0418E, 0518F, 1218C).	5270 units

Based on the official FDA remedy

What to do — step by step

Check Device Lot Number
Identify the lot number on the packaging to determine if it is in the recalled list of lots.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 2 states.

FDA distribution: “US Nationwide distribution in the states of CA and FL.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: California, Florida.

Recall timeline

FDA published this recall 37 days after the firm started it.

Feb 1, 2021Firm started the recall
Feb 26, 2021FDA classified it Class II
Mar 10, 2021Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/63323-bovie-conmed-disposable-bipolar-ablators-recall-sterile-packaging-risk">Bovie ConMed Disposable Bipolar Ablators Recall: Sterile Packaging Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1155-2021 (February 1, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1155-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.