Z-0421-2021Class II

3M Red Dot Monitoring Electrode with 4mm Adapter -

Name: Z-0421-2021 3M Red Dot Monitoring Electrode with 4mm Adapter -
Creator: 3M Company - Health Care Business
Published: 2020-09-15
License: https://open.fda.gov/license/

3M Company / initiated 2020-09-15 / Terminated / root cause: manufacturing process

FDA source

3M Company - Health Care Business began a recall of 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... on 2020-09-15. FDA classified it as Class II and gives the reason as "Corrosion could cause performance failures in the product". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0421-2021
Classification: Class II
Status: Terminated
Initiated: 2020-09-15
Posted: 2020-11-05
Terminated: 2022-02-01
Recalling firm: 3M Company
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).
Product code: DRX Electrode, Electrocardiograph
Reason for recall: Corrosion could cause performance failures in the product.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 287,200 units
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).
Product codes and lots: 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)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0421-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0419-2021	Class II	Terminated	Voluntary: Firm initiated	2020-11-11	2020-11-05
Z-0420-2021	Class II	Terminated	Voluntary: Firm initiated	2020-11-11	2020-11-05
Z-0421-2021	Class II	Terminated	Voluntary: Firm initiated	2020-11-11	2020-11-05
Z-0422-2021	Class II	Terminated	Voluntary: Firm initiated	2020-11-11	2020-11-05
Z-0423-2021	Class II	Terminated	Voluntary: Firm initiated	2020-11-11	2020-11-05

Product code DRX

K970796Class II3M Red Dot 2560 & 2570 Monitoring Electrodes3M Healthcare / cleared 1997-04-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)