FDA-Device2026-05-20Class IIPACKAGING DEFECT
Stryker Daig Livewire Steerable catheter recalled for incomplete sterile seals
Nationwide distribution
Stryker Daig Livewire catheter recalled for incomplete seals
Stryker Sustainability Solutions identified incomplete seals on certain lots of the Daig Livewire Steerable reprocessed electrophysiology catheter (Product Number 401923). The affected units may not maintain sterility, which could pose a risk during use. Three units have been affected.
- Check your product for Lot Numbers 3557411, 3702628, or 4498116.
- If you have an affected unit, contact Stryker Sustainability Solutions or your supplier for instructions on return or replacement.
- Do not use affected catheters until you have received guidance from the manufacturer.
Hazard
Incomplete seals on sterile product
Sold states
US Nationwide and the countries of Israel and Canada.
Affected count
3 units
Manufactured in
1810 W Drake Dr, Tempe, AZ, United States
Products
Daig Livewire Steerable, Product Number 401923; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2196-2026More Stryker Sustainability Solutions recalls
- FDA-Device2026-05-20Stryker BARD Dynamic Tip Steerable catheter recalled for incomplete sterile seals
- FDA-Device2026-05-20Stryker BARD Dynamic Deca Steerable catheter recalled for incomplete sterile seals
- FDA-Device2026-05-20Stryker Daig Livewire Steerable catheter recalled for incomplete sterile seals
- FDA-Device2026-05-20Stryker BARD EP XT Decapolar Steerable catheters recalled for incomplete sterile seals
- FDA-Device2026-05-20Stryker Daig Livewire Steerable catheters recalled for incomplete sterile seals
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