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FDA (Device enforcement)Recalled 2026-04-10class ii

Stryker Sustainability Solutions: BARD EP XT Steerable, Product Number 200794; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Hazard

Incomplete seals on sterile product

Details from the source

Reason for recall: Incomplete seals on sterile product Distribution: US Nationwide and the countries of Israel and Canada. Quantity: 44 units Lot/code info: 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.

UPC codes

00885825003739

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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