3M Red Dot Electrodes, Radiolucent Monitoring Electrode with Foam Tape, Catalog No. 2244, (3M ID ...

FDA Device Recall #Z-0188-2022 — Class II — October 6, 2021

Recall Summary

Recall Number Z-0188-2022
Classification Class II — Moderate risk
Date Initiated October 6, 2021
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm 3M Company - Health Care Business
Location Saint Paul, MN
Product Type Devices
Quantity 2,081,000 electrodes

Product Description

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.

Distribution Pattern

US Nationwide Distribution to states of: AL, AZ, CA, IA, IL, LA, MD, MO, NC, NJ, and OH; and OUS Foreign distribution to countries of: Australia, Bermuda, Canada, China, France, Germany, Japan, the Netherlands, Singapore, Sweden, and Turkey.

Lot / Code Information

Lot #202302LK, Exp. 2023-02-19, pouch UDI (01)1070738789449(17)230219(11)202302LK, shipper box UDI (01)50707387789447(17)230219(11)202302LK Lot #202302LL, Exp. 2023-02-22, pouch UDI (01)1070738789449(17)230222(11)202302LL, shipper box UDI (01)50707387789447(17)230222(11)202302LL; Lot #202302LM, Exp. 2023-02-22, pouch UDI (01)1070738789449(17)230222(11)202302LM, shipper box UDI (01)50707387789447(17)230222(11)202302LM; Lot #202302LN, Exp. 2023-02-23. pouch UDI (01)1070738789449(17)230223(11)202302LN, shipper box UDI (01)50707387789447(17)230223(11)202302LN.

Other Recalls from 3M Company - Health Care Business

Recall # Classification Product Date
Z-0743-2025 Class II Clarity Precision Grip Attachments, for use in ... Nov 22, 2024
Z-0038-2025 Class II 3M Tegaderm CHG, Chlorhexidine Gluconate I.V. S... Aug 14, 2024
Z-1633-2024 Class II 3M Durapore Surgical Tape, Catalog Number 1538-118 Mar 20, 2024
Z-1475-2024 Class II 3M Tube Securement Device, Small, 1.7 IN/PO x 2... Feb 20, 2024
Z-1170-2024 Class II 3M Specialty Blade Assembly, REF 9660,70-2011-8... Jan 12, 2024

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.