FDA DeviceClass IINotable

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

Date: 2026-05-20
Brand: Stryker Sustainability Solutions
Category: Medical Device
FDA Class: Class II

Description

Incomplete seals on sterile product

Hazard

Incomplete seals on sterile product

Remedy

816 units

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