Recall
FDAHealthApril 10, 2026

Stryker Sustainability Solutions — BARD Dynamic Tip Steerable, Product Number 200131; 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 200131; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Lot code
3966097

Additional details

UDI 00885825002930, Lot Numbers: 3966097, 4314254, 4490535, 4511367, 4517632, 4607771, 4762688, 4056491, 4401626, 4490540, 4511368, 4567842, 4628229, 4775309, 4137164, 4455383, 4490542, 4511369, 4567844, 4628232, 4875058, 4154024, 4463033, 4490544, 4511370, 4567866, 4628234, 5023284, 4165178, 4472622, 4495807, 4511372, 4567888, 4628242, 5023285, 4250497, 4490533, 4502016, 4511375, 4567898, 4665767, 5069705, 4300586, 4490534, 4511155, 4514004, 4607745, 4762686.

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 61 units.

View original FDA notice →

Get Health recall alerts

Delivered to your inbox. Free. No account required.