FDAClass II · Medical device · Recall Z-2403-2026 · Recalled June 17, 2026

Boston Scientific TCN Electrodes recall — Boston Scientific Neuromodulation Corporation

Agency report date: June 17, 2026.

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.

2. Agency hazard and consumer action

FDA reports: Reusable electrodes may not meet expected performance levels.

No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.

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

Affected product: Boston Scientific TCN Electrodes

3. Open the official notice or contact

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-2403-2026
Brand: Boston Scientific Neuromodulation
Classification: Class II
Units affected: 49,251 units
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Affected products

Boston Scientific TCN Electrodes

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: 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.
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

Verify with the official sources:

CPSC — consumer products ↗ (aggregated here)
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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 ↗

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Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes; the linked government source is authoritative. Source last checked September 7, 2026 at 6:00 AM UTC. Record retrieved September 7, 2026 at 6:00 AM UTC.

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