FDA recall Z-2189-2026
Stryker Sustainability Solutions · Class II · device
Product
Daig Livewire Steerable, Product Number 401603, REPROCESSED ELECTROPHYSIOLOGY CATHETER
Reason for recall
Incomplete seals on sterile product
Distribution
US Nationwide and the countries of Israel and Canada.
Key facts
- Status
- Ongoing
- Initiation date
- 2026-04-10
- Report date
- 2026-05-20
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Tempe, AZ, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2189-2026