In the agency's Nov 18, 2026 enforcement report · Ongoing
TCD Electrodes (Description/REF(Inner/Outer))
Boston Scientific Neuromodulation Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Boston Scientific Neuromodulation Corporation · 25155 Rye Canyon Loop · Valencia, CA · 91355-5004
Is this the product you have?
TCD Electrodes (Description/REF(Inner/Outer))
5 of 5 products
| # | Product as published |
|---|---|
| 1 | TCD Electrode, Multi-Pack, 3M Cable, 10cm x 28ga (0.36mm)/(TCD-10-3M/TCD-10-3M-P) |
| 2 | TCD Electrode, Multi-Pack, 10cm x 28ga (0.36mm)/(TCD-10/TCD-10-P) |
| 3 | TCD Electrode, Multi-Pack, 3M Cable, 15cm x 28ga (0.36mm)/(TCD-15-3M/TCD-15-3M-P) |
| 4 | TCD Electrode, Multi-Pack, 15cm x 28ga (0.36mm)/(TCD-15/TCD-15-P) |
| 5 | TCD Electrode, Multi-Pack, 5cm x 28ga (0.36mm)/(TCD-5/TCD-5-P) |
- Lot codes and dates
5 of 5 products
Products covered by this recall # Barcodes Product as published 1 00813250014396TCD-10-3M/00813250014396/39749333(7/6/2030), 85009822(7/12/2030) 2 00813250010978TCD-10/00813250010978/39741131(7/5/2030), 39750861(7/6/2030), 39757187(7/7/2030), 39766608(7/8/2030), 39768774(7/8/2030), 39772208(7/9/2030), 39778427(7/9/2030), 39780344(7/9/2030), 39781367(7/10/2030), 85006486(7/12/2030), 85011925(7/13/2030) 3 00813250014402TCD-15-3M/00813250014402/39770714(7/8/2030) 4 00813250010985TCD-15/00813250010985/39741129(7/5/2030), 39746187(7/6/2030), 39780349(7/10/2030), 39783782(7/10/2030) 5 00813250010961TCD-5/00813250010961/39751579(7/7/2030), 39783599(7/10/2030) - Amount recalled
- 13320
Where it was sold
Why it was recalled
Radiofrequency probes may have small cut marks on the Tyvek side of the sterile pouch, and if the sterile barrier is compromised and devices are used, this could cause microbial or other foreign material contamination to be introduced into patient tissue, which may lead to infection, pain, inflammation, allergic reaction, toxicity, the need for additional medical and/or surgical intervention.
This product could cause temporary or reversible health problems — stop using it.
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