FDA (Devices) recall action 86519
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.
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.
3M is recalling Red Dot Monitoring Electrodes because corrosion could cause performance failures in the ECG monitoring product.
3M is recalling Novaplus Monitoring Electrodes because corrosion could cause performance failures. The recall affects 156,600 units distributed worldwide.
3M is recalling Red Dot Monitoring Electrodes because corrosion could cause performance failures in the ECG monitoring product.
3M is recalling Novaplus Monitoring Electrodes because corrosion could cause performance failures. The recall affects 1,572,000 units distributed worldwide.
3M is recalling Red Dot Monitoring Electrodes because corrosion could cause performance failures in the ECG monitoring product.