FDA DevicesClass II
Daig Livewire Steerable, Product Number 401915; REPROCESSED ELECTROPHYSIOLOGY CA...
Published: May 20, 2026Recall ID: Z-2195-2026Category: devicesCountry: US
Reason for Recall / Hazard
Incomplete seals on sterile product
Product Description & Identification
Daig Livewire Steerable, Product Number 401915; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Additional Source Details
| Field | Value |
|---|---|
| City | Tempe |
| State | AZ |
| Event id | 98708 |
| Address 1 | 1810 W Drake Dr |
| Code info | UDI 00885825007300, Lot Numbers: 1772607, 3994138, 4539200, 4808444, 4985924, 5010522, 5042942, 2482952, 4046485, 4539206, 4808677, 4986242, 5010524, 5042944, 2521570, 4164020, 4540476, 4812775, 4986243, 5017909, 5042945, 2521636, 4166570, 4544644, 4817888, 4986244, 5018848, 5043881, 2521660, 4182322, 4549452, 4824089, 4986245, 5020135, 5043883, 2577590, 4183176, 4549458, 4824092, 4986256, 5020136, 5052391, 2711877, 4206584, 4549460, 4824093, 4986399, 5020139, 5056580, 2769403, 4216286, 4551863, 4825561, 4993904, 5020147, 5060152, 2769695, 4247577, 4567736, 4830114, 4993905, 5020149, 5060153, 2787951, 4260013, 4569285, 4833151, 4993910, 5020453, 5060154, 2919616, 4274184, 4569297, 4850593, 4993912, 5024412, 5060155, 2919619, 4275872, 4569532, 4854631, 4993914, 5024413, 5060156, 2919623, 4287229, 4569539, 4854632, 4993915, 5025667, 5060157, 2986771, 4295030, 4577350, 4861162, 4993916, 5029412, 5060158, 3186438, 4390731, 4579539, 4861163, 4993920, 5032327, 5060159, 3269091, 4414236, 466... [TRUNCATED] |
| Postal code | 85283-4327 |
| Report date | 20260520 |
| Product type | Devices |
| Product quantity | 206 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.