FDA Device recall Z-2190-2026
Daig Livewire Steerable, Product Number 401652
- 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 401652 by Stryker Sustainability Solutions, citing incomplete seals on sterile product.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2190-2026 |
| 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 401652; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Reason
Incomplete seals on sterile product
Identifiers
| code_info | UDI 00885825006983, Lot Numbers: 3430230, 4648604, 4945422, 4999751, 5044134, 5059493, 4454505, 4882788, 4950218, 4999…UDI 00885825006983, Lot Numbers: 3430230, 4648604, 4945422, 4999751, 5044134, 5059493, 4454505, 4882788, 4950218, 4999755, 5044135, 5086419, 4454517, 4945388, 4993562, 5044132, 5044136, 5086420, 4648603, 4945405, 4993565, 5044133, 5044137. |
|---|
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-2190-2026%22
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