Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0723-2013·Announced 2013-01-30

ConMed Recalls Goldvac UltraClean Accessory Electrode Due to Seal Compromise

ConMed is recalling Goldvac 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 2/5 (Moderate).

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 source explicitly states that no illnesses or injuries have been reported and the hazard is theoretical (sterility compromise), which aligns with the Moderate severity criteria for low-risk contamination or voluntary precautionary recalls.

Plain-English summary

ConMed Corporation is recalling Goldvac(TM) UltraClean(R) Accessory Electrode 6 inch Coated Blades, REF/Catalog No. 60-7526-001. The recall involves 313,190 units distributed nationwide in the United States, Puerto Rico, and internationally to 23 other countries. The affected lot codes range from 120628X to 120917X.

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 in all reported instances.

ConMed has not received any reports that a compromise in the sterile barrier resulted in illness or injury. Healthcare providers and consumers should stop using the affected devices and contact ConMed for further instructions.

The recalled product

Product: Goldvac(TM) UltraClean(R) Accessory Electrode 6 inch Coated Blade, REF/Catalog No. 60-7526-001, 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