3M Red Dot Monitoring Electrode with Foam Tape — Class II medical device recall Z-0423-2021
Terminated recall by 3M Company - Health Care Business, reported 2020-11-11, distributed nationwide. Corrosion could cause performance failures in the product.
| Recall number | Z-0423-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | 3M Company - Health Care Business, Saint Paul, MN, United States |
| Recall initiated | 2020-09-15 |
| Classified | 2020-11-05 |
| Reported by FDA | 2020-11-11 |
| Terminated | 2022-02-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, BE, CA, CH, CN, CR, DE, ES, FI, FR, GR, ID, IE, IT, JP, MX, NL, NO, PE, PT, SE, SG, TW |
| Quantity | 720,000 |
| UPC / GTIN / UDI-DI | 10707387789524, 50707387789522 |
| Lot numbers | 202204MA |
| Model numbers | 2228 |
| Expiration dates | 2020-04-27 |
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).
Reason for recall
Corrosion could cause performance failures in the product.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0423-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.