Lower risk Medical device recall · FDA · Published September 15, 2020

3M Red Dot Electrodes: Corrosion Risk in ECG Monitoring Devices

3M recalls 1000 ECG electrodes with foam tape due to corrosion risk causing performance failures. Healthcare professionals should check product lot numbers and contact 3M for details.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0422-2021Medical device 3M ›

Lower-risk recall

Corrosion could cause performance failures in the product.

Take action

Contact the company

Recalling firm3M Company - Health Care Business3m Center 2510 Conway Ave, Bldg 275-5W-06 · Saint Paul, MN 55144-0001

✎ GovInfoNow plain-language explainer

3M is recalling 1000 ECG monitoring electrodes that could corrode and cause performance failures. Healthcare professionals using these electrodes should stop using them immediately to avoid potential monitoring errors. Read more at govinfonow.com/recall/64281-3m-red-dot-electrodes-corrosion-risk-in-ecg-monitoring-devices.

Source Summary by GovInfoNow · govinfonow.com/recall/64281-3m-red-dot-electrodes-corrosion-risk-in-ecg-monitoring-devices · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0422-2021

Cite this page

“3M Red Dot Electrodes: Corrosion Risk in ECG Monitoring Devices.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64281-3m-red-dot-electrodes-corrosion-risk-in-ecg-monitoring-devices. Based on FDA recall #Z-0422-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0422-2021%22&limit=1).

The FDA announced on 2020-09-15 that 3M Company - Health Care Business is recalling 3M Red Dot Monitoring Electrodes with Foam Tape due to potential corrosion causing performance failures, according to the FDA.

How to tell if you have it

3M Red Dot Monitoring Electrode with Foam Tape
Cat. No. 2228 (SKU: 70-2007-8021-4, SAP # 7100009333)
GTIN: 10707387582200 (pouch) and 50707387786996 (shipper)
Lots: 202204LF, 202204LG, 202204LH, 202204LJ, 202204LK, 202204LL, 202204LM, 202204LN, 202204LP, 202204LQ, 202204LR, 202204LS, 202204LT, 202204LU, 202204LV, 202204LW, and 202204LY

The hazard

Corrosion could cause performance failures in the product, according to the FDA.

Context

GovInfoNow's records show 3M Company - Health Care Business has 17 other recalls on record since 2015-08-06. Other recent recalls of similar products include 3M Clarity Precision Grip Attachments May Not Mate Properly in Orthodontic Treatment (2024-11-22), 3M Tegaderm CHG Dressing Recall: Contamination Risk (2024-08-14), and 3M Durapore Surgical Tape: Incorrect 5-Year Shelf Life Label (2024-03-20). Other recent recalls of similar products include Boston Scientific TCN Electrodes May Not Meet Performance Levels (2026-04-29), Codman Microsensor Basic Kit Recall: Potential Corrosion Stains on Tuohy Needle (2025-12-12), and Codman CereLink ICP Sensor Basic Kit Recall: Potential Corrosion Stains (2025-12-12).

How to tell if you have this one

Check the product lot numbers: 202204LF through 202204LY. These electrodes are sold in pouches with 50 units per pouch and 20 pouches per box (1000 total).

Brand
3M
Product
3M Red Dot Monitoring Electrode with Foam Tape
Category
Medical device

FDA recall event · 5 products

All 5 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Terminated
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).

Recall number	Product, codes & lots	Quantity
Z-0419-2021	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).; Cat. No. V2560-5 (SKU: 70-2011-8381-4, SAP #: 7100205978). GTIN: 10707387788176 (pouch) and 50707387788174 (shipper) Lots: 202112EQ (Expiration 2021-12-09); 202201EA (Expiration 2022-01-01); 202205EH (Expiration 2022-05-14); and 202205EI (Expiration 2022-05-19)	1,572,000 units
Z-0420-2021	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).; Cat. No. V2560-3 (SKU: 70-2011-8380-6, SAP #: 7100205820). GTIN: 10707387788169 (pouch); 50707387788167 (shipper) Lots: 202201EB (Expiration 2022-01-01)	156,600 units
Z-0421-2021	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).; Cat. No. 2228BA (SKU: CH-0000-1642-8, SAP #: 7000032072). GTIN: 10707387582200 (pouch); 50707387786996 (shipper) Lots: 202204BA (Expiration 2020-04-20); 202204BB (Expiration 2020-04-22); 202204BC (Expiration 2020-04-27); 202204BD (Expiration 2020-04-28); 202204BE (Expiration 2020-04-29); 202204BF (Expiration 2020-04-30); 202204BG (Expiration 2020-05-04); 202204BH (Expiration 2020-05-05); 202204BI (Expiration 2020-05-07); 202204BJ (Expiration 2020-05-12); 202204BK (Expiration 2020-05-14); 202204BL (Expiration 2020-05-22); 202204BM (Expiration 2020-05-28); and 202204BN (Expiration 2020-06-02)	287,200 units
Z-0422-2021	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).; Cat. No. 2228 (SKU: 70-2007-8021-4, SAP # 7100009333). GTIN: 10707387582200 (pouch) and 50707387786996 (shipper) Lots:202204LF (Expiration 2020-04-07); 202204LG (Expiration 2020-04-08); 202204LH (Expiration 2020-04-09); 202204LJ (Expiration 2020-04-13); 202204LK (Expiration 2020-04-13); 202204LL (Expiration 2020-04-14); 202204LM (Expiration 2020-04-15); 202204LN (Expiration 2020-04-16); 202204LP (Expiration 2020-04-17); 202204LQ (Expiration 2020-04-17); 202204LR (Expiration 2020-04-20); 202204LS (Expiration 2020-04-20); 202204LT (Expiration 2020-04-21); 202204LU (Expiration 2020-04-21); 202204LV (Expiration 2020-04-22); 202204LW (Expiration 2020-04-22); and 202204LY (Expiration 2020-04-24)	10,145,050 units
Z-0423-2021	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).; Cat. No. 2228 (SKU: 70-2011-8514-0, SAP # 7100212952). GTIN: 10707387789524 (pouch) and 50707387789522 (shipper) Lots: 202204MA (Expiration 2020-04-27)	720,000

Based on the official FDA remedy

What to do — step by step

Check Product Lot Number
Look for lot numbers on the packaging: 202204LF through 202204LY.
Contact 3M for Details
Reach out to 3M directly for specific instructions on handling the recalled product.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA terminated this recall 17 months after the firm started it.

Sep 15, 2020Firm started the recall
Nov 5, 2020FDA classified it Class II
Nov 11, 2020Published in FDA’s Enforcement Report
Feb 1, 2022FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

What is the expiration date for the recalled electrodes?

The expiration dates range from April 7, 2020 to April 24, 2020 depending on the lot number.

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Link to this recall

<a href="https://govinfonow.com/recall/64281-3m-red-dot-electrodes-corrosion-risk-in-ecg-monitoring-devices">3M Red Dot Electrodes: Corrosion Risk in ECG Monitoring Devices (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0422-2021 (September 15, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0422-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.