FDA Device recall Z-2188-2026
Daig Livewire Steerable, Product Number 401582
- FDA Device
- Class II
- ongoing
- Published 2026-05-20
On 2026-05-20 the FDA classified a Class II recall of Daig Livewire Steerable, Product Number 401582 by Stryker Sustainability Solutions, citing incomplete seals on sterile product.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2188-2026 |
| 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
Daig Livewire Steerable, Product Number 401582; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Reason
Incomplete seals on sterile product
Identifiers
| code_info | UDI 00885825006884, Lot Numbers: 3002664, 4092049, 4580888, 4627994, 4778840, 4860529, 4998452, 4026540, 4098358, 4620…UDI 00885825006884, Lot Numbers: 3002664, 4092049, 4580888, 4627994, 4778840, 4860529, 4998452, 4026540, 4098358, 4620256, 4627999, 4813542, 4985859, 4072508, 4498128, 4620257, 4755333, 4860528, 4985861. |
|---|
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-2188-2026%22
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