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Lower risk Medical device recall · FDA · Published October 6, 2021

3M Red Dot Electrodes: Risk of ECG Electrode Carbon Stud Breakage

3M recalls radiolucent ECG electrodes with foam tape due to potential carbon stud breakage. Affected units include specific lots and expiration dates. Consumers should check product details to determine if recalled.

🇺🇸 FDA recall #Z-0188-2022Medical device3M ›
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Recalling firm3M Company - Health Care Business3m Center 2510 Conway Ave, Bldg 275-5W-06 · Saint Paul, MN 55144-0001
✎ GovInfoNow plain-language explainer

What happened, in plain English

3M is recalling radiolucent ECG electrodes with foam tape that may break, causing injury. This recall affects healthcare professionals using the electrodes for monitoring. The breakage could lead to skin irritation or other issues if the electrode fragments during use. Read more at govinfonow.com/recall/61714-3m-red-dot-electrodes-risk-of-ecg-electrode-carbon-stud.

Source Summary by GovInfoNow · govinfonow.com/recall/61714-3m-red-dot-electrodes-risk-of-ecg-electrode-carbon-stud · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0188-2022

Cite this page

“3M Red Dot Electrodes: Risk of ECG Electrode Carbon Stud Breakage.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61714-3m-red-dot-electrodes-risk-of-ecg-electrode-carbon-stud. Based on FDA recall #Z-0188-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0188-2022%22&limit=1).

Why it’s dangerous

The carbon stud in the electrode can break from the eyelet, potentially causing skin irritation or injury if fragments are left on the skin. This breakage is a minor hazard that does not typically cause serious injury.

Who’s affected

Healthcare professionals who use the 3M Red Dot Electrodes for ECG monitoring are most at risk. The recall applies to specific lots and expiration dates of the electrodes.

How to tell if you have this one

Check for the product name '3M Red Dot Electrodes, Radiolucent Monitoring Electrode with Foam Tape' and catalog number 2244. Affected units have specific lot numbers (202302LK to 202302LN) and expiration dates between February 19 and February 23, 2023.

  • Brand
    3M
  • Product
    3M Red Dot Electrodes, Radiolucent Monitoring Electrode with Foam Tape, Catalog No. 2244, (3M ID (SKU): 70-2011-8506-6
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Identify the product by checking the catalog number (2244) and lot numbers (202302LK to 202302LN) on the packaging.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 11 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: named in the noticeILWisconsin: nationwideWIMichigan: nationwideMINew York: nationwideNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: named in the noticeIAIndiana: nationwideINOhio: named in the noticeOHPennsylvania: nationwidePANew Jersey: named in the noticeNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: named in the noticeMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: named in the noticeMDDelaware: nationwideDEArizona: named in the noticeAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: named in the noticeNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: named in the noticeLAMississippi: nationwideMSAlabama: named in the noticeALGeorgia: nationwideGAHawaii: nationwideHITexas: nationwideTXFlorida: nationwideFL

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

Named in the notice: Alabama, Arizona, California, Illinois, Iowa, Louisiana, Maryland, Missouri, New Jersey, North Carolina, Ohio.

Recall timeline

FDA terminated this recall 2.3 years after the firm started it.

1. Firm started the recall: Oct 6, 202112. FDA classified it Class II: Nov 1, 202123. Published in FDA’s Enforcement Report: Nov 10, 202134. FDA terminated the recall: Jan 17, 2024420212024
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

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

✎ GovInfoNow

Questions people ask

What should I do if I have the recalled product?

Check the product details to confirm if you have a recalled unit. If so, contact 3M for further instructions.

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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-0188-2022 (October 6, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0188-2022 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA