FDA recall Z-2191-2026
Stryker Sustainability Solutions · Class II · device
Product
Daig Livewire Steerable, Product Number 401904; 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-2191-2026