# FDA recall Z-0422-2021

> **3M Company - Health Care Business** · Class II · device recall initiated 2020-09-15.

## 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).

## Reason for recall

Corrosion could cause performance failures in the product.

## Distribution

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).

## Key facts

- **Recall number:** Z-0422-2021
- **Recalling firm:** 3M Company - Health Care Business
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-09-15
- **Report date:** 2020-11-11
- **Termination date:** 2022-02-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Saint Paul, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0422-2021

## Citation

> AI Analytics. FDA recall Z-0422-2021. Retrieved 2026-07-27 from https://api.ai-analytics.org/recall/Z-0422-2021. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*