Medical device recalls Moderate risk

Stryker Sustainability Solutions recalls BARD EP XT Decapolar Steerable, Product Number 201007; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Recall date
April 10, 2026
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2181-2026
FDA classification
Class II
Brand / firm
Stryker Sustainability Solutions
Sold / distributed
US Nationwide and the countries of Israel and Canada.

Why it was recalled

Incomplete seals on sterile product

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

BARD EP XT Decapolar Steerable, Product Number 201007; REPROCESSED ELECTROPHYSIOLOGY CATHETER

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