# FDA recall Z-0188-2022

> **3M Company - Health Care Business** · Class II · device recall initiated 2021-10-06.

## Product

3M Red Dot Electrodes, Radiolucent Monitoring Electrode with Foam Tape, Catalog No. 2244, (3M ID (SKU): 70-2011-8506-6, SAP ID: 7100212989), packaged 10 electrodes per card, 5 cards per pouch, 20 pouches per shipper box, 1,000 electrodes total per shipper box.    The 3M Red Dot Radiolucent Monitoring Electrode with Foam Tape 2244 is intended to be used by healthcare professionals for ECG monitoring. This electrode is disposable, intended for single use, and has been tested for up to 3 days wear.

## Reason for recall

Potential for breakage of the ECG electrode carbon stud from the eyelet.

## Distribution

US Nationwide Distribution to states of: AL, AZ, CA, IA, IL, LA, MD, MO, NC,  NJ, and OH; and OUS Foreign distribution to countries of: Australia, Bermuda, Canada, China, France, Germany, Japan, the Netherlands, Singapore, Sweden, and Turkey.

## Key facts

- **Recall number:** Z-0188-2022
- **Recalling firm:** 3M Company - Health Care Business
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-10-06
- **Report date:** 2021-11-10
- **Termination date:** 2024-01-17

- **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-0188-2022

## Citation

> AI Analytics. FDA recall Z-0188-2022. Retrieved 2026-06-14 from https://api.ai-analytics.org/recall/Z-0188-2022. Source: US FDA. Licensed CC0.

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