Boston Scientific CSK Electrodes Recall: Reusable electrodes may not meet performance
Boston Scientific recalls CSK Electrodes with specific model numbers due to potential performance issues. Affected units may not function as intended, but no injuries reported. Consumers should check model details and contact for guidance.
Lower-risk recall
Reusable electrodes may not meet expected performance levels.
Contact the company
What happened, in plain English
Boston Scientific is recalling certain CSK Electrodes that may not meet expected performance levels. This could affect the device's reliability, though no injuries have been reported in this recall. Read more at govinfonow.com/recall/49322-boston-scientific-csk-electrodes-recall-reusable-electrodes-may-not-meet.
Source Summary by GovInfoNow · govinfonow.com/recall/49322-boston-scientific-csk-electrodes-recall-reusable-electrodes-may-not-meet · Updated August 17, 2026 · FDA enforcement record: FDA #Z-2402-2026
Cite this page
“Boston Scientific CSK Electrodes Recall: Reusable electrodes may not meet performance.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/49322-boston-scientific-csk-electrodes-recall-reusable-electrodes-may-not-meet. Based on FDA recall #Z-2402-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2402-2026%22&limit=1).
Why it’s dangerous
The electrodes may not perform as intended, which could lead to improper medical treatment. However, the recall does not indicate a risk of injury or serious harm in normal use.
Who’s affected
Users of Boston Scientific CSK Electrodes with model numbers CSK-TC10, CSK-TC15, CSK-TC20, or CSK-TC5 are likely affected. Patients using these devices for medical purposes are at the highest risk.
How to tell if you have this one
Check the product model number on the electrode, which includes CSK-TC10, CSK-TC15, CSK-TC20, or CSK-TC5. The product also has specific lot numbers and UDI codes listed in the recall notice.
- Brand
Boston Scientific- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
Worldwide distribution - US Nationwide and the countries of PE, MX, PR, CO, MY, CA.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-2402-2026 | Boston Scientific CSK Electrodes: REF: CSK-TC10, CSK Electrode, STAINLESS STEEL, 10 cm x 28 ga (0.36 mm) REF: CSK-TC10-3M,CSK Electrode, STAINLESS STEEL, 3M Cable, 10 cm x 28 ga (0.36 mm); REF: CSK-TC15, CSK Electrode, STAINLESS STEEL, 15 cm x 28 ga (0.36 mm); REF: CSK-TC15-3M, CSK Electrode, STAINLESS STEEL, 3M Cable, 15 cm x 28 ga (0.36 mm) REF: CSK-TC20, CSK Electrode, STAINLESS STEEL, 20 cm x 28 ga (0.36 mm) REF: CSK-TC5,CSK Electrode, STAINLESS STEEL, 5 cm x 28 ga (0.36 mm); REF: CSK-TC5-3M, CSK Electrode, STAINLESS STEEL, 3M Cable, 5 cm x 28 ga (0.36 mm); All Lots: / UDI: CSK-TC10:00813250010107; CSK-TC10-3M: 00813250011524; CSK-TC15 00813250010114; CSK-TC15-3M: 00813250011548 CSK-TC20: 0081325001140; CSK-TC5: 00813250010091; CSK-TC5-3M: 00813250011531; | 31,923 units |
| Z-2403-2026 | Boston Scientific TCN Electrodes: REF: TCN-5, TCN Electrode, NITINOL, 5 cm x 0.45 mm (0.0175 in); REF:TCN-10, TCN Electrode, NITINOL, 10 cm x 0.45 mm (0.0175 in) REF:TCN-15, TCN Electrode, NITINOL, 15 cm x 0.45 mm (0.0175 in); REF:TCN-20, TCN Electrode, NITINOL, 20 cm x 0.45 mm (0.0175 in) REF: TCN-5-3m, TCN Electrode, NITINOL, 3M CABLE, 5 cm x 0.45 mm (0.0175 in) REF: TCN-10-3M, TCN Electrode, NITINOL, 3M CABLE, 10 cm x 0.45 mm (0.0175 in); REF: TCN-15-3M, TCN Electrode, NITINOL, 3M CABLE, 15 cm x 0.45 mm (0.0175 in) REF: TCN-20-3M, TCN Electrode, NITINOL, 3M CABLE, 20 cm x 0.45 mm (0.0175 in); All Lots: / UDI: TCN-10: 00813250013054; TCN-10-3M: 00813250017502; TCN-15: 00813250013061; TCN-15-3M: 00813250017519; TCN-20: 00813250013078; TCN-20-3M: 00813250017526; TCN-5: 00813250013047; TCN-5-3M:00813250017533 | 49,251 units |
What to do — step by step
Check Product Model
Identify the model number on the electrode, which should be CSK-TC10, CSK-TC15, CSK-TC20, or CSK-TC5.
Contact Manufacturer
Reach out to Boston Scientific for further guidance on the recall and potential next steps.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide distribution - US Nationwide and the countries of PE, MX, PR, CO, MY, CA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 49 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2402-2026 (April 29, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2402-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.