The Recall Desk
ModerateFDA (Devices)·Z-0727-2013·Announced 2013-01-30

ConMed Recalls Electrosurgical ENT Needle Electrodes Due to Compromised Sterile Seals

ConMed is recalling 313,190 electrosurgical ENT needle 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 hazard was discovered prior to use, fitting the criteria for a moderate risk or voluntary precautionary recall.

Plain-English summary

ConMed Corporation is recalling 313,190 units of Electrosurgical ENT Needle Electrodes, 6 inch with Extended Insulation (REF/Catalog No. 138025). The recall was initiated after the company received complaints and confirmed instances where the sterile pouch seal was compromised on the affected products.

The affected devices were distributed worldwide, including nationwide in the United States, Puerto Rico, and internationally to countries such as Belgium, Colombia, India, Japan, and Mexico. The lot codes for the recalled devices range from 120628X to 120917X. The compromised seals were discovered prior to use in all reported instances.

ConMed has not reported any instances where the compromised sterile barrier resulted in illness or injury. Healthcare providers and consumers should check their inventory for the specific lot codes and stop using any affected devices.

The recalled product

Product
ELECTROSURGICAL ENT NEEDLE ELECTRODE, 6 inch with Extended Insulation, REF/Catalog No. 138025, Single Use, Sterile, Rx ONLY -- CONMED CORPORATION Electrosurgical, Cutting and Coagulation and Accessories.
Manufacturer
ConMed Corporation
Category
Medical Device — Surgical Instruments
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

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Same hazard · sterility compromise

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