Red Dot Monitoring Electrode (3M) – corrosion risk (2020)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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).
Brand
3M Company Health Care Business 3m Center
Lot Codes / Batch Numbers
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)
Products Sold
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)
3M Company Health Care Business 3m Center is recalling 3M Red Dot Monitoring Electrode with 4mm Adapter - Product Usage: intended to be used by healthcare due to Corrosion could cause performance failures in the product.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Corrosion could cause performance failures in the product.
Recommended Action
Per FDA guidance
The recalling firm issued customer letters to consignees on 10/7-8/2020. The recalling firm is requesting a returned acknowledgement form from the consignee. Distributors will also be sent a template customer letter and customer acknowledgement so that they may notify their customers. The recalling firm will initiate multiple attempts to follow up with non responders. Customers and distributors are requested to dispose of any products still in their possession.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026