CLASS II ONGOING Device recall · Reported 17 Jun 2026 · FDA Enforcement Report
Boston Scientific CSK Electrodes recalled
Boston Scientific Neuromodulation is recalling Boston Scientific CSK Electrodes, distributed nationwide in the US. The recall was initiated on 29 Apr 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2402-2026
- FDA event ID
- 98939
- Recalling firm
- Boston Scientific Neuromodulation, Valencia, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 29 Apr 2026
- FDA classified
- 11 Jun 2026
- Reported
- 17 Jun 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 29 Apr 2026 | Recall initiated by company | |
| 11 Jun 2026 | Classified by FDA | +43 days |
| 17 Jun 2026 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Reusable electrodes may not meet expected performance levels.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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)
Where it was distributed
Worldwide distribution - US Nationwide and the countries of PE, MX, PR, CO, MY, CA.
Questions about this recall
Why was it recalled?
Reusable electrodes may not meet expected performance levels.
Which lots are affected?
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;
Where was it sold?
Worldwide distribution - US Nationwide and the countries of PE, MX, PR, CO, MY, CA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 98939| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Boston Scientific TCN Electrodes recalled | Boston Scientific Neuromodulation | Device Malfunction | Nationwide |
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