FDA Device Intelligence
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Electrode, Electrosurgical

FDA product code JOS · Class 2 · General, Plastic Surgery

520
Registered devices
798
Adverse events
9
Recalls
36
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2019-11-18Boston Scientific CorporationDuring testing on the Habib EUS RFA device, a temperature increase was observed at the tip of the EUS-FNA needle. It was determined that capacitive 5 coupling p
2019-11-18Boston Scientific CorporationDuring testing on the Habib EUS RFA device, a temperature increase was observed at the tip of the EUS-FNA needle. It was determined that capacitive 5 coupling p
2016-08-29ConMed CorporationCONMED received complaints of damage to the CS-023 electrodes shaft insulation which could result in burn marks on the shaft. If the shaft insulation is damage
2012-09-17Boston Scientific CorporationLeveen Standard and Leveen Coaccess Needle Electrode System, Directions for Use(DFU) in Portuguese, are incorrect. all other languages in the DFU are correct
2012-09-17Boston Scientific CorporationLeveen Standard and Leveen Coaccess Needle Electrode System, Directions for Use(DFU) in Portuguese, are incorrect. all other languages in the DFU are correct
2008-08-08Sterilmed IncSteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. The removal is being conducted becau
2006-08-29Olsen MedicalTesting conducted by the firm indicates that electrodes identified with certain part numbers may fall out from the electrosurgical pencil or handle presenting t
2004-09-303M Company / Medical DivisionImproper wire placement from the patient plate to the ESU connector plug results in an intermittent displacement connection.
2004-06-16Rita Medical SystemsInaccurate temperature readings may be displayed by the device, actual temperature could be 2.5-3 degrees C higher than displayed.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.