FDA Enforcement
Class II
Ongoing
Daig Livewire Steerable, Product Number 401652; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Recall: Z-2190-2026
·
Reported May 20, 2026
Enforcement
- Recall Number
- Z-2190-2026
- Event ID
- 98708
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Stryker Sustainability Solutions
- Voluntary / Mandated
- Voluntary: Firm initiated
- Report Date
- May 20, 2026
- Initiation Date
- April 10, 2026
- Classification Date
- May 13, 2026
- Address
- 1810 W Drake Dr, Tempe, AZ, 85283-4327, United States
Description
Daig Livewire Steerable, Product Number 401652; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Reason
Incomplete seals on sterile product
Code Info
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.
Distribution
US Nationwide and the countries of Israel and Canada.
Quantity
24 units