FDA DeviceClass IINotable

FDA Recall: BARD EP XT Decapolar Steerable, Product Number 201007; 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

217 units

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