3M Red Dot Electrodes — Class II medical device recall Z-0188-2022

Terminated recall by 3M Company - Health Care Business, reported 2021-11-10, distributed nationwide. Potential for breakage of the ECG electrode carbon stud from the eyelet.

Recall number	`Z-0188-2022`
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	2021-10-06
Classified	2021-11-01
Reported by FDA	2021-11-10
Terminated	2024-01-17
Distributed	Nationwide (US)
Countries outside the US	AU, BM, CA, CN, DE, FR, JP, NL, SE, SG, TR
Quantity	2,081,000 electrodes
Reason classes	device malfunction
UPC / GTIN / UDI-DI	`50707387789447`
Lot numbers	`202302LK`, `202302LL`, `202302LM`, `202302LN`
Model numbers	`2244`
Expiration dates	`2023-02-19`, `2023-02-22`, `2023-02-23`

Product

3M Red Dot Electrodes, Radiolucent Monitoring Electrode with Foam Tape, Catalog No. 2244, (3M ID (SKU): 70-2011-8506-6, SAP ID: 7100212989), packaged 10 electrodes per card, 5 cards per pouch, 20 pouches per shipper box, 1,000 electrodes total per shipper box. The 3M Red Dot Radiolucent Monitoring Electrode with Foam Tape 2244 is intended to be used by healthcare professionals for ECG monitoring. This electrode is disposable, intended for single use, and has been tested for up to 3 days wear.

Reason for recall

Potential for breakage of the ECG electrode carbon stud from the eyelet.

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-0188-2022. 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.