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The official notice did not include a photo. Check the product details and identifiers below.
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Transvenous Pacing Electrode Tray w Bipolar Balloon Pacing Electrode 5F, REF: 008416A, 008566A
Official notice
22 Jul 2026
Last checked
22 Sept 2026
An official FDA notice concerns Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F, REF: 008416A, 008566A. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2026-07-22. Recall numbers: Z-2704-2026. Check the official notice for the complete list.
What to do now
Instructions for consumers are available in the official FDA notice.
Units affected
950
Recall number
Z-2704-2026
Official notice
2026-06-01
The hazard
The hazard
Health risk requiring medical assessment
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
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Recall Numbers
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Turn on recall alertsAffected products
Affected products
Product 1
Units affected
Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Brand: Argon Medical Devices. Contact: Argon Medical Devices, Inc.
Source & status
Source & status
Recall details
Recall details
Recall number
Event id
Units affected
Status
Classification
Source tier
Documents, notices & source
See the official notice and source documents for full details.
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