FDA Enforcement
Class II
Ongoing
Daig Livewire Steerable, Product Number 401603, REPROCESSED ELECTROPHYSIOLOGY CATHETER
Recall: Z-2189-2026
·
Reported May 20, 2026
Enforcement
- Recall Number
- Z-2189-2026
- 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 401603, REPROCESSED ELECTROPHYSIOLOGY CATHETER
Reason
Incomplete seals on sterile product
Code Info
UDI 00885825006969, Lot Numbers: 3978113, 4465650, 4468623, 4594989, 4622932, 4622934, 4629627, 4665006, 4720693.
Distribution
US Nationwide and the countries of Israel and Canada.
Quantity
9 units