The Recall Desk
ModerateFDA (Devices)·Z-0718-2013·Announced 2013-01-30

ConMed Recalls Disposable Hyfrecator Electrodes Due to Compromised Sterile Seals

ConMed is recalling 313,190 disposable Hyfrecator electrodes because some sterile pouch seals were compromised. No illnesses or injuries have been reported.

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, but the source explicitly states that no illnesses or injuries have been reported and the compromised seals were discovered prior to use, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

ConMed Corporation is recalling 313,190 units of Electrolase Hyfrecator Electrodes - Sharp, Disposable Hyfrecator Tips (REF/Catalog No. 7-100-8CS). The recall was initiated after the company received complaints that some devices had broken through the seal of the sterile pouch. ConMed confirmed that the pouch seals were compromised on the affected products.

The affected lot codes range from 120628X to 120917X. These devices were distributed nationwide in the United States, Puerto Rico, and internationally to Belgium, Colombia, Czech Republic, Dubai, Guatemala, Hong Kong, India, Israel, Italy, Japan, Kenya, Kuwait, Malaysia, Mexico, New Zealand, Norway, Oman, Pakistan, Portugal, Saudi Arabia, Thailand, and Uruguay.

In no instance has it been reported to ConMed that a compromise in the sterile barrier has resulted in illness or injury. The compromised seals were discovered prior to use. Healthcare providers should stop using these devices and contact ConMed for further instructions.

The recalled product

Product
ELECTROLASE(R) HYFRECATOR(R) ELECTRODES - SHARP, Disposable Hyfrecator(R) Tips, REF/Catalog No. 7-100-8CS, Sterile, Rx ONLY -- CONMED CORPORATION Electrosurgical, Cutting and Coagulation and Accessories.
Manufacturer
ConMed Corporation
Category
Medical Device — Electrosurgical Accessories
Hazard
Affected units
313,190

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.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 20 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 20 products in this recall →

Related recalls

Same manufacturer · ConMed Corporation

See all →

Same hazard · sterile barrier compromise

See all →