FDAHealthApril 10, 2026

Stryker Sustainability Solutions — BARD Dynamic Tip Steerable, Product Number 200344; REPROCESSED ELECTROPHYSIOLOGY CATHETER

⚠️ Incomplete seals on sterile product

Is this relevant to me?

Geography: Nationwide
Source agency: FDA
Category: Health
Published: April 10, 2026

US Nationwide and the countries of Israel and Canada.

What's affected?

Product: BARD Dynamic Tip Steerable, Product Number 200344; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Brand: Stryker Sustainability Solutions
Lot code: 2268964

Additional details

UDI 00885825003135, Lot Numbers: 2268964, 2687510, 3173767, 3269330, 3379246, 4398753, 4876242, 2501717, 2878890, 3231930, 3336473, 3394078, 4780878, 4876243, 2533915, 3137651, 3266358, 3361335, 3454810, 4821709.

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 28 units.

View original FDA notice →

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