The Recall Desk
HighFDA (Devices)·Z-2403-2026·Announced 2026-06-17

[pending] Boston Scientific TCN Electrodes: REF: TCN-5, TCN Electrode, NITINOL, 5 cm x 0.45 mm (0.0175 in);

Pending LLM rewrite. Source: FDA_DEVICE Z-2403-2026.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Pending LLM scoring against the rubric.

Plain-English summary

Reusable electrodes may not meet expected performance levels.

The recalled product

Product
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
Manufacturer
Boston Scientific Neuromodulation Corporation
Category
Medical Device — Devices

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (8)

  • 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

Distributed nationwide across the United States.

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