The Recall Desk
HighFDA (Devices)·Z-0422-2021·Announced 2020-11-11

3M Red Dot Monitoring Electrode Recall Due to Corrosion Risk

3M is recalling Red Dot Monitoring Electrodes because corrosion could cause performance failures in the ECG monitoring product.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of performance failure in a medical device used for monitoring, which fits the criteria for a High severity score where injury has not yet been reported.

Plain-English summary

3M Company - Health Care Business is recalling 3M Red Dot Monitoring Electrodes with Foam Tape. The recall involves 10,145,050 units of the product, which is intended to be used by healthcare professionals for ECG monitoring. The product is distributed worldwide, including in the United States, Europe, and various countries in Asia, the Americas, and Canada.

The recall is being conducted because corrosion could cause performance failures in the product. The affected lots have expiration dates ranging from April 7, 2020, to April 24, 2020. The specific lot codes are 202204LF, 202204LG, 202204LH, 202204LJ, 202204LK, 202204LL, 202204LM, 202204LN, 202204LP, 202204LQ, 202204LR, 202204LS, 202204LT, 202204LU, 202204LV, 202204LW, and 202204LY.

Healthcare professionals should check their inventory for these specific lot numbers and expiration dates. If the product is found, it should be removed from use and returned to 3M or the distributor according to the recall instructions.

The recalled product

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).
Manufacturer
3M Company - Health Care Business
Category
Medical Device — ECG Monitoring Electrodes
Hazard
Affected units
10,145,050

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (17)

  • Cat. No. 2228 (SKU: 70-2007-8021-4
  • 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)

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 5 recalled by 3M Company - Health Care Business under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

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