RecallRadar

FDA Device recall Z-2182-2026

BARD EP XT Steerable, Product Number 200794

On 2026-05-20 the FDA classified a Class II recall of BARD EP XT Steerable, Product Number 200794 by Stryker Sustainability Solutions, citing incomplete seals on sterile product.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2182-2026
ClassificationClass II
Statusongoing
Initiated2026-04-10
Published2026-05-20
Last updated2026-09-13 11:58 UTC
CompanyStryker Sustainability Solutions
DistributionUS

Product

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

Reason

Incomplete seals on sterile product

Identifiers

code_info
UDI 00885825003739, Lot Numbers 4573219, 4869696, 4992244, 4999900, 5025367, 5038410, 5085389, 4804556, 4971805, 499224…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.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2182-2026%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.