The Recall Desk

FDA (Devices) recall action 86519

3M Company - Health Care Business recalled 5 products on 2020-11-11

The FDA (Devices) publishes a recall like this one as 5 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 5 pages.

Products
5
Announced
2020-11-11
Critical
0
Units
12,880,850

Why these products were recalled

Corrosion could cause performance failures in the product.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–5 of 5

  • HighFDA (Devices)··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 1,572,000 units distributed worldwide.

    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).
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2020-11-11

    3M Red Dot Monitoring Electrode Recall Due to Corrosion Risk

    3M is recalling Red Dot Monitoring Electrodes because corrosion could cause performance failures in the ECG monitoring product.

    Product
    3M Red Dot Monitoring Electrode with 4mm Adapter - Product Usage: intended to be used by healthcare professionals for ECG monitoring. 10 electrodes per card; 4 cards per pouch; 20 pouches per shipper box (800 electrodes total).
    Category
    Distribution
    0 states
  • HighFDA (Devices)··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.

    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).
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2020-11-11

    3M Red Dot Monitoring Electrode Recall Due to Corrosion Risk

    3M is recalling Red Dot Monitoring Electrodes because corrosion could cause performance failures in the ECG monitoring product.

    Product
    3M Red Dot Monitoring Electrode with Foam Tape - Product Usage: intended to be used by healthcare professionals for ECG monitoring. 50 electrodes per pouch; 20 pouches per shipper box (1000 electrodes total).
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2020-11-11

    3M Red Dot Monitoring Electrode Recall Due to Corrosion Risk

    3M is recalling Red Dot Monitoring Electrodes because corrosion could cause performance failures in the ECG monitoring product.

    Product
    3M Red Dot Monitoring Electrode with Foam Tape - Product Usage: intended to be used by healthcare professionals for ECG monitoring. 50 electrodes per pouch; 20 pouches per shipper box (1000 electrodes total).
    Category
    Distribution
    0 states