Boston Scientific Neuromodulation Corporation recalls Boston Scientific CSK Electrodes: REF: CSK-TC10

Recalling company

Boston Scientific Neuromodulation Corporation

Product

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 – may cause temporary or medically reversible health consequences

Recall date

Apr 29, 2026

Reported

Jun 17, 2026

Distribution

Worldwide distribution - US Nationwide and the countries of PE, MX, PR, CO, MY, CA.

Status

Ongoing

Quantity

31,923 units

Lot / codes

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;

Company location

Valencia, CA

Recall type

Voluntary: Firm initiated

Recall number

Z-2402-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-2402-2026 in the FDA Enforcement Report. Also see FDA recall press releases.