FDA-Device2026-05-20Class IIPACKAGING DEFECT
Stryker Daig Livewire Steerable catheters recalled for incomplete sterile seals
What this means
Stryker Sustainability Solutions identified incomplete seals on certain lots of Daig Livewire Steerable electrophysiology catheters. The incomplete seals may compromise sterility of the product. Approximately 206 units across multiple lot numbers were affected.
- Check your inventory for affected lot numbers (provided in the full recall notice).
- Do not use affected catheters.
- Contact Stryker for product replacement or return instructions.
The agency's original wording
Hazard
Incomplete seals on sterile product
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide and the countries of Israel and Canada.
Affected count
206 units
Manufactured in
1810 W Drake Dr, Tempe, AZ, United States
Products
Daig Livewire Steerable, Product Number 401915; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2195-2026More Stryker recalls
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