The Recall Desk
ModerateFDA (Devices)·Z-0827-2013·Announced 2013-02-27

ConMed Recalls Electrolase Hyfrecator Electrodes Due to Compromised Sterile Seals

ConMed is recalling specific lots of Electrolase Hyfrecator electrodes because some sterile pouch seals were compromised, potentially affecting sterility.

What this means for you

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. The hazard involves compromised sterile seals, which is a significant quality defect, but the source text does not report any illnesses, injuries, or hospitalizations, placing it in the Moderate category per the rubric.

Plain-English summary

ConMed Corporation is recalling specific lots of Electrolase Hyfrecator electrodes, catalog number 7-101-8BX. These are disposable, sterile, prescription-only tips intended to be used as active RF electrodes for desiccation, fulguration, and coagulation.

The recall was initiated because ConMed confirmed instances where the seal of the sterile pouch was broken or compromised on the affected products. This defect may affect the sterility of the devices.

The recall covers domestic distribution of 97,450 units and foreign distribution of 6,800 units. The products were distributed nationwide in the United States and in China, Dubai, and Indonesia. Affected lot codes range from 120628X to 120917X. Healthcare providers and facilities should stop using these devices and contact ConMed for further instructions.

The recalled product

Product
ELECTROLASE(R) HYFRECATOR(R) ELECTRODES - BLUNT, REF/Catalog Number 7-101-8BX, Disposable Hyfrecator(R) Tips, Sterile, Rx Only --- CONMED CORPORATION USA. Intended to be used as active RF electrodes for desiccation, fulguration and coagulation.
Manufacturer
ConMed Corporation
Category
Medical Device — Surgical Instruments
Hazard

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 (9)

  • Beginning Lot Code 120628X
  • 09 represents the month (September)
  • 17 represents the day of the month
  • and X represents the manufacturing shift code (1
  • 2
  • 3
  • 4
  • 5
  • 6 or 9)].

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by ConMed 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 2 products in this recall →

Related recalls

Same manufacturer · ConMed Corporation

See all →

Same hazard · sterility compromise

See all →