FDA DevicesClass II
Daig Livewire Steerable, Product Number 401603, REPROCESSED ELECTROPHYSIOLOGY CA...
Published: May 20, 2026Recall ID: Z-2189-2026Category: devicesCountry: US
Reason for Recall / Hazard
Incomplete seals on sterile product
Product Description & Identification
Daig Livewire Steerable, Product Number 401603, REPROCESSED ELECTROPHYSIOLOGY CATHETER
Additional Source Details
| Field | Value |
|---|---|
| City | Tempe |
| State | AZ |
| Event id | 98708 |
| Address 1 | 1810 W Drake Dr |
| Code info | UDI 00885825006969, Lot Numbers: 3978113, 4465650, 4468623, 4594989, 4622932, 4622934, 4629627, 4665006, 4720693. |
| Postal code | 85283-4327 |
| Report date | 20260520 |
| Product type | Devices |
| Product quantity | 9 units |
| Reason for recall | Incomplete seals on sterile product |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260410 |
| Center classification date | 20260513 |
Overview
- Recalling FirmStryker Sustainability Solutions
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide and the countries of Israel and Canada.