FDAHealthApril 10, 2026
Stryker Sustainability Solutions — BARD EP XT Steerable, Product Number 200794; 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 EP XT Steerable, Product Number 200794; REPROCESSED ELECTROPHYSIOLOGY CATHETER
- Lot code
- 4573219
Additional details
UDI 00885825003739, Lot Numbers 4573219, 4869696, 4992244, 4999900, 5025367, 5038410, 5085389, 4804556, 4971805, 4992245, 4999902, 5032111, 5043783, 4804558, 4971806, 4992246, 5012684, 5032112, 5043784, 4809474, 4990763, 4992247, 5012708, 5032113, 5043785, 4829451, 4990764, 4993772, 5012709, 5033926, 5043787, 4835199, 4990769, 4997966, 5012711, 5033927, 5056579, 4841812, 4992243, 4998135, 5012726, 5033928, 5056828.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 44 units.
Get Health recall alerts
Delivered to your inbox. Free. No account required.