FDA-Device2026-05-20Class IIPACKAGING DEFECT
Stryker Daig Livewire Steerable electrophysiology catheters recalled for incomplete sterile seals
Nationwide distributionMedical devices
What this means
Stryker Sustainability Solutions identified incomplete seals on certain lots of Daig Livewire Steerable reprocessed electrophysiology catheters. The seal defect could allow contamination of the sterile product. Affected units were distributed in the US, Canada, and Israel.
- Check if you have any of the affected lot numbers listed in this recall.
- Stop using affected catheters and contact your Stryker representative or facility procurement for return instructions.
- Verify your current inventory against the lot numbers before use in any procedure.
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
319 units
Manufactured in
1810 W Drake Dr, Tempe, AZ, United States
Products
Daig Livewire Steerable, Product Number 401575; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2186-2026More Stryker recalls
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