Boston Scientific TCN Electrodes: recall status

Notice names this product. Boston Scientific Neuromodulation’s Boston Scientific TCN Electrodes is named in FDA Class II recall Z-2403-2026. Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies. Agency-reported hazard: Reusable electrodes may not meet expected performance levels. Identifying details: All Lots: / UDI: TCN-10: 00813250013054; TCN-10-3M: 00813250017502; TCN-15: 00813250013061; TCN-15-3M: 00813250017519; TCN-20: 00813250013078; TCN-20-3M: 00813250017526; TCN-5: 00813250013047; TCN-5-3M:00813250017533. Units affected: 49,251 units. Status: Ongoing.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named: Boston Scientific TCN Electrodes
Company / brand: Boston Scientific Neuromodulation
Lot / serial / date codes: All Lots: / UDI: TCN-10: 00813250013054; TCN-10-3M: 00813250017502; TCN-15: 00813250013061; TCN-15-3M: 00813250017519; TCN-20: 00813250013078; TCN-20-3M: 00813250017526; TCN-5: 00813250013047; TCN-5-3M:00813250017533
Distribution: Worldwide distribution - US Nationwide and the countries of PE, MX, PR, CO, MY, CA.

Agency product description and boundaries

Boston Scientific TCN Electrodes: REF: TCN-5, TCN Electrode, NITINOL, 5 cm x 0.45 mm (0.0175 in); REF:TCN-10, TCN Electrode, NITINOL, 10 cm x 0.45 mm (0.0175 in) REF:TCN-15, TCN Electrode, NITINOL, 15 cm x 0.45 mm (0.0175 in); REF:TCN-20, TCN Electrode, NITINOL, 20 cm x 0.45 mm (0.0175 in) REF: TCN-5-3m, TCN Electrode, NITINOL, 3M CABLE, 5 cm x 0.45 mm (0.0175 in) REF: TCN-10-3M, TCN Electrode, NITINOL, 3M CABLE, 10 cm x 0.45 mm (0.0175 in); REF: TCN-15-3M, TCN Electrode, NITINOL, 3M CABLE, 15 cm x 0.45 mm (0.0175 in) REF: TCN-20-3M, TCN Electrode, NITINOL, 3M CABLE, 20 cm x 0.45 mm (0.0175 in)

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

Brand: Boston Scientific Neuromodulation

Recalls naming this model

FDA Class II · Medical device · June 17, 2026

Boston Scientific TCN Electrodes recall — Boston Scientific Neuromodulation Corporation

Reusable electrodes may not meet expected performance levels.

Company / brand: Boston Scientific Neuromodulation

Affected product: Boston Scientific TCN Electrodes

Official ID Z-2403-2026 · Official record ↗

See all Boston Scientific Neuromodulation recalls →

Verify with the official sources:

CPSC — consumer products ↗ (aggregated here)
NHTSA — vehicles, car seats, tires ↗ (aggregated here; use NHTSA's VIN lookup to check a specific vehicle)
FDA — food, drugs, medical devices ↗ (aggregated here)
USDA FSIS — meat, poultry & processed egg products ↗ (not aggregated here)
Recalls.gov — the U.S. government’s all-agency portal ↗

Found something wrong or missing? Report a data error.

Compiled from connected official public-domain government data. Sources last checked September 7, 2026 at 6:00 AM UTC.