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FDA (Device enforcement)Recalled 2026-04-29class ii

Boston Scientific Neuromodulation Corporation: 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,

Hazard

Reusable electrodes may not meet expected performance levels.

Details from the source

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. Quantity: 31,923 units Lot/code info: 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;

UPC codes

00813250010107, 00813250011524, 00813250010114, 00813250011548, 0081325001140, 00813250010091, 00813250011531

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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