3M Recalls Novaplus Monitoring Electrodes Due to Corrosion Risk
3M is recalling Novaplus Monitoring Electrodes because corrosion could cause performance failures. The recall affects 1,572,000 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 involves a risk-of-harm product (medical device performance failure) where injury has not yet been reported, which aligns with the 'High' severity criteria in the rubric.
Plain-English summary
3M Company - Health Care Business is recalling Novaplus Monitoring Electrodes with Foam Tape and Sticky Gel. The recall is being conducted because corrosion could cause performance failures in the product. These electrodes are intended to be used by healthcare professionals for ECG monitoring.
The recall involves 1,572,000 units of the product, identified by Cat. No. V2560-5. The affected lots are 202112EQ, 202201EA, 202205EH, and 202205EI. The product was distributed nationwide in the United States and in various countries in Europe, Asia, and the Americas.
Healthcare professionals should stop using the affected electrodes and contact 3M for further instructions. The source text does not report any specific injuries or illnesses associated with this recall.
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. 5 electrodes per card; 1 card per pouch; 200 pouches per shipper box (1000 electrodes total).
- Manufacturer
- 3M Company - Health Care Business
- Category
- Medical Device — ECG Electrodes
- Affected units
- 1,572,000
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 (4)
- Cat. No. V2560-5 (SKU: 70-2011-8381-4
- 202201EA (Expiration 2022-01-01)
- 202205EH (Expiration 2022-05-14)
- and 202205EI (Expiration 2022-05-19)
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.
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