Boston Scientific CSK Electrodes Recall
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Boston Scientific Neuromodulation Corporation is recalling 31,923 units of CSK Electrodes due to potential failure to meet expected performance levels.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on July 27, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, devices.
What Happened
Boston Scientific Neuromodulation Corporation initiated a voluntary recall of certain CSK Electrodes because the reusable electrodes may not meet expected performance levels. The recall is classified as Class II by the FDA and affects units distributed worldwide.
Which Products Are Affected
The affected products include:
- 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)
All lots are affected. Total quantity: 31,923 units. UDI codes: CSK-TC10:00813250010107; CSK-TC10-3M:00813250011524; CSK-TC15:00813250010114; CSK-TC15-3M:00813250011548; CSK-TC20:0081325001140; CSK-TC5:00813250010091; CSK-TC5-3M:00813250011531. Distribution includes US nationwide and the countries of PE, MX, PR, CO, MY, CA. Recall number Z-2402-2026.
What You Should Do
No specific consumer action steps are provided in the recall notice. The recall was initiated voluntarily by the firm via letter.
Why This Matters
This ongoing Class II recall involves more than 31,000 medical device units distributed across the United States and internationally.
Source
FDA recall Z-2402-2026
Original source: FDA Official Notice ↗
Related FDA Recalls
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Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,585 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to July 27, 2026.
Frequently Asked Questions
Common questions about this FDA recall.