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Recall Observatory FDA recall evidence

Device product

BARD EP XT Steerable, Product Number 200794; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Z-2182-2026

April 10, 2026

Class II

Product summary

Firm
Stryker Sustainability Solutions
Event
Event 98708
Status
Ongoing
Classification
Class II
Quantity
44 units
Official record key
device-enforcement:Z-2182-2026

Official wording

Reason: Incomplete seals on sterile product

Code information: 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.

Distribution pattern: US Nationwide and the countries of Israel and Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Incomplete seals on sterile product