Official recall notice

FDA DeviceClass IINotable

CS Uni-Directional w Auto ID Recall (May 2026)

Product: CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Recall date
2026-05-20
FDA class
Class II

Why it was recalled

Hazard

Incomplete seals on sterile product

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Product description

Incomplete seals on sterile product

Verify with the official notice →
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