Agency classClass IIOur severity:High FDA (Devices)·Z-0730-2013·Announced 2013-01-30

ConMed Recalls UltraClean Accessory Electrodes Due to Compromised Sterile Seals

ConMed is recalling UltraClean Accessory Electrodes because some sterile pouch seals were compromised. No illnesses or injuries have been reported.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (sterile medical device) where injury has not yet been reported, meeting the criteria for a High severity score.

Plain-English summary

ConMed Corporation is recalling UltraClean(R) Accessory Electrode 1 inch Coated Needles (REF/Catalog No. 139102) due to reports of compromised sterile pouch seals. The affected devices are single-use, sterile, and prescription-only electrosurgical accessories.

The recall was initiated after ConMed received complaints that some devices had broken through the seal of the sterile pouch. The company confirmed that the pouch seals were compromised on the affected products. The compromised seals were discovered prior to use.

ConMed has not reported any instances where the compromised sterile barrier resulted in illness or injury. The affected units were distributed worldwide, including in the United States, Puerto Rico, and various international locations.

The recalled product

Product: UltraClean(R) Accessory Electrode 1 inch Coated Needle, REF/Catalog No. 139102, Single Use, Sterile, Rx ONLY -- CONMED CORPORATION Electrosurgical, Cutting and Coagulation and Accessories.
Manufacturer: ConMed Corporation
Category: Medical Device — Electrosurgical Accessories
Hazard: sterility-compromise
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 →

Same manufacturer · ConMed Corporation

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Same hazard · sterility compromise