3M Red Dot recallZ-0423-2021 · 3M Company - Health Care Business · initiated Sep 15, 2020
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from 3M Company - Health Care Business or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Corrosion could cause performance failures in the product.
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-0423-2021
- Status
- Terminated
- Initiated by the company
- Sep 15, 2020
- Recalling firm
- 3M Company - Health Care Business
- Quantity
- 720,000
- Product code
- DRX
- FDA submissions
- K970796
- 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 description
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).
Code information (models, lots, serial numbers)
Cat. No. 2228 (SKU: 70-2011-8514-0, SAP # 7100212952). GTIN: 10707387789524 (pouch) and 50707387789522 (shipper) Lots: 202204MA (Expiration 2020-04-27)
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- 3M™ Red Dot™ 22283m Company · Electrode, electrocardiograph1 recall4 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 86519).
- Z-0421-2021 · Terminated3M 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; …
- Z-0422-2021 · Terminated3M 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 shipp…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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