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FDAClass II · Medical device · Recalled June 17, 2026

Boston Scientific CSK Electrodes recall — Boston Scientific Neuromodulation Corporation

Hazard: Reusable electrodes may not meet expected performance levels.

Class II: may cause temporary or medically reversible health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID
Z-2402-2026
Brand
Boston Scientific Neuromodulation
Classification
Class II
Units affected
31,923 units
Recall status
Ongoing
Initiated
Voluntary: Firm initiated

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)

Affected products

Companies & origin

Recalling firm location
Valencia, CA, United States
Firm address
25155 Rye Canyon Loop, N/A, 91355-5004

Identifying details (verbatim from the notice)

Product codes / lots
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;
Distribution
Worldwide distribution - US Nationwide and the countries of PE, MX, PR, CO, MY, CA.
Firm notified the public via
Letter
FDA event ID
98939
Recall initiated
April 29, 2026
FDA classified
June 11, 2026
FDA report date
June 17, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 24, 2026 at 3:00 AM UTC.

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