FDAFDA · Food and drugs·Recall number Z-2182-2026
BARD EP XT Steerable, Product Number 200794; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Published May 20, 2026 · Recall initiated: April 10, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Incomplete seals on sterile product
What to do
Voluntary: Firm initiated
Recall details
- Manufacturer
- Stryker Sustainability Solutions
- Distributor
- US Nationwide and the countries of Israel and Canada.
- Lot
- 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.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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