CLASS II Device recall · Reported 11 Nov 2020 · FDA Enforcement Report
Novaplus Monitoriing Electrode with Foam Tape and Sticky Gel recalled
3M Company - Health Care Business is recalling Novaplus Monitoriing Electrode with Foam Tape and Sticky Gel, distributed nationwide in the US. The recall was initiated on 15 Sep 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0420-2021
- FDA event ID
- 86519
- Recalling firm
- 3M Company - Health Care Business, Saint Paul, MN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Sep 2020
- FDA classified
- 5 Nov 2020
- Reported
- 11 Nov 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Hip & Knee Implants
Timeline
| 15 Sep 2020 | Recall initiated by company | |
| 5 Nov 2020 | Classified by FDA | +51 days |
| 11 Nov 2020 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Corrosion could cause performance failures in the product.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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).
Where it was distributed
Worldwide distribution - US Nationwide distribution and the countries of Europe (Austria, Belgium, Switzerland, Germany, Spain, Finland, France, Greece, Ireland, Italy, Netherlands, Norway, Portugal, Sweden) and Worldwide (China, Taiwan, Singapore, Indonesia, Japan, Mexico, Peru, Costa Rica, Canada).
Questions about this recall
Why was it recalled?
Corrosion could cause performance failures in the product.
Which lots are affected?
Cat. No. V2560-3 (SKU: 70-2011-8380-6, SAP #: 7100205820). GTIN: 10707387788169 (pouch); 50707387788167 (shipper) Lots: 202201EB (Expiration 2022-01-01)
Where was it sold?
Worldwide distribution - US Nationwide distribution and the countries of Europe (Austria, Belgium, Switzerland, Germany, Spain, Finland, France, Greece, Ireland, Italy, Netherlands, Norway, Portugal, Sweden) and Worldwide (China, Taiwan, Singapore, Indonesia, Japan, Mexico, Peru, Costa Rica, Canada).
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
4 other products · FDA event 86519This product is part of a recall event; the main page for the event is 3M Red Dot Monitoring Electrode with Foam Tape recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | 3M Red Dot Monitoring Electrode with Foam Tape recalled | 3M Company - Health Care Business | Device Malfunction | Nationwide | |
| CLASS II | 3M Red Dot Monitoring Electrode with Foam Tape recalled | 3M Company - Health Care Business | Device Malfunction | Nationwide | |
| CLASS II | Novaplus Monitoriing Electrode with Foam Tape and Sticky Gel recalled | 3M Company - Health Care Business | Device Malfunction | Nationwide | |
| CLASS II | 3M Red Dot Monitoring Electrode with Adapter recalled | 3M Company - Health Care Business | Device Malfunction | Nationwide |
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