FDA Medical Device Recalls (openFDA)
Bovie Medical Corporation: ConMed Disposable Bipolar Ablators - Product Usage: intended to be used for cutting, vaporization, and coagulation of soft tissue during arthroscopic surgical procedures.
- Recall number
- Z-1155-2021
- Recalling firm
- Bovie Medical Corporation
- Product
- ConMed Disposable Bipolar Ablators - Product Usage: intended to be used for cutting, vaporization, and coagulation of soft tissue during arthroscopic surgical procedures.
- Status
- Open, Classified
- Initiated
- 2021-02-01
- Posted
- not on file
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Device Design
- Action
- The firm sent "URGENT MEDICAL DEVICE RECALL" (FA-2021-1) and response form to customers on February 1, 2021.
- Quantity
- 5270 units
- Distribution
- US Nationwide distribution in the states of CA and FL.
- Lot, serial or model codes
- 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).
- 510(k) numbers
- ["K152777","K161558"]
- PMA numbers
- not on file
- Product code
- GEI
- Firm FEI
- 3007593903
- Firm city
- Clearwater
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28