Recall
FDAHealthApril 10, 2026

Stryker Sustainability Solutions — BARD Dynamic XT Deca Steerable, Product Number 201102, 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 XT Deca Steerable, Product Number 201102, REPROCESSED ELECTROPHYSIOLOGY CATHETER
Lot code
3975235

Additional details

UDI 00885825003869, Lot Numbers: 3975235, 4253785, 4277547, 4297459, 4656095, 4818154, 4972266, 4065815, 4253786, 4277548, 4297460, 4656096, 4818155, 5032390, 4180953, 4253791, 4296975, 4363237, 4717623, 4818156, 5032392, 4223973, 4254918, 4296977, 4404427, 4717624, 4831929, 5032393, 4253773, 4254919, 4296978, 4481136, 4717625, 4831931, 5032394, 4253774, 4254921, 4296979, 4494845, 4742015, 4836645, 5032395, 4253775, 4254922, 4296980, 4542475, 4742017, 4836646, 5032710, 4253778, 4254923, 4296981, 4544586, 4742018, 4858708, 5055855, 4253779, 4277541, 4296982, 4545898, 4788864, 4858709, 5055858, 4253782, 4277544, 4297456, 4656082, 4788865, 4881310, 5073042, 4253783, 4277545, 4297457, 4656093, 4788866, 4967746, 5079052, 4253784, 4277546, 4297458, 4656094, 4807750, 4972265.

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 90 units.

View original FDA notice →

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