HIGHFDA DEVICE

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:...

Reusable electrodes may not meet expected performance levels.

Boston Scientific NeuromodulationHealth & Personal CareMedical DevicesAll Lots: / UDI: CSK-TC10:00813250010107CSK-TC10-3M: 00813250011524CSK-TC15 00813250010114

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DEVICE
Recall date
April 29, 2026
Status
ACTIVE

Quick Facts at a Glance

Recall Date
April 29, 2026
Hazard Level
HIGH
Brand
Boston Scientific Neuromodulation
Geographic Scope
1 states

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
  4. 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand
Boston Scientific Neuromodulation
Model numbers
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 affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    April 29, 2026

  2. Reported by FDA DEVICE

    June 17, 2026

  3. RecallRadar source check

    June 23, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

Hazard Information

Reusable electrodes may not meet expected performance levels.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Boston Scientific Neuromodulation Corporation or your healthcare provider for instructions. Notification method: Letter

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Full Description

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). Reason: Reusable electrodes may not meet expected performance levels.. Classification: Class II. Quantity: 31,923 units. Distribution: Worldwide distribution - US Nationwide and the countries of PE, MX, PR, CO, MY, CA.

Safety Guide

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Read: How to Get Refunds and Replacements

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Product Classification

Product Details

Model Numbers
All Lots: / UDI: CSK-TC10:00813250010107
CSK-TC10-3M: 00813250011524
CSK-TC15 00813250010114
CSK-TC15-3M: 00813250011548 CSK-TC20: 0081325001140
CSK-TC5: 00813250010091
+1 more
Affected States
ALL
Report Date
June 17, 2026
Recall Status
ACTIVE

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