The Recall Desk
HighFDA (Devices)·Z-0420-2021·Announced 2020-11-11

3M Recalls Novaplus Monitoring Electrodes Due to Corrosion Risk

3M is recalling Novaplus Monitoring Electrodes because corrosion could cause performance failures. The recall affects 156,600 units distributed worldwide.

What this means for you

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 is classified as FDA Class II and involves a risk of performance failure in a medical device used for monitoring, which fits the criteria for a High severity rating where injury has not yet been reported.

Plain-English summary

3M Company - Health Care Business is recalling 156,600 units of Novaplus Monitoring Electrodes with Foam Tape and Sticky Gel. The product is intended for use by healthcare professionals for ECG monitoring. The recall is due to a risk that corrosion could cause performance failures in the product.

The affected product is identified by Catalog No. V2560-3 (SKU: 70-2011-8380-6, SAP #: 7100205820) and Lot 202201EB, with an expiration date of 2022-01-01. The product was distributed nationwide in the United States and in various countries across Europe, Asia, and the Americas.

Healthcare professionals should stop using the affected electrodes and contact 3M for instructions on how to return the product. This recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Novaplus Monitoriing Electrode with Foam Tape and Sticky Gel - Product Usage: intended to be used by healthcare professionals for ECG monitoring. 3 electrodes per card; 1 card per pouch; 200 pouches per shipper box (600 electrodes total).
Manufacturer
3M Company - Health Care Business
Category
Medical Device — ECG Electrodes
Hazard
Affected units
156,600

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 (3)

  • Cat. No. V2560-3 (SKU: 70-2011-8380-6
  • SAP #: 7100205820). GTIN: 10707387788169 (pouch)
  • 50707387788167 (shipper) Lots: 202201EB (Expiration 2022-01-01)

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 5 recalled by 3M Company - Health Care Business 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 5 products in this recall →

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