FDA recall Z-2402-2026

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 for recall

Reusable electrodes may not meet expected performance levels.

Distribution

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

Key facts

Status

Ongoing

Initiation date

2026-04-29

Report date

2026-06-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Valencia, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2402-2026