FDA Device recall Z-2182-2026
BARD EP XT Steerable, Product Number 200794
- FDA Device
- Class II
- ongoing
- Published 2026-05-20
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
| Agency | FDA Device |
|---|---|
| Recall number | Z-2182-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-04-10 |
| Published | 2026-05-20 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Stryker Sustainability Solutions |
| Distribution | US |
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
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