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 sterile seals
Stryker Sustainability Solutions is recalling Daig Livewire Steerable electrophysiology catheters (Product Number 401908) due to incomplete seals on the sterile packaging. This affects 3 units with specific lot numbers distributed in the US, Canada, and Israel. Incomplete seals could allow contamination of the sterile product.
- Check your inventory for lot numbers 3459566, 3623281, and 4191726
- Do not use affected units
- Contact Stryker for return or replacement instructions
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 401908; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2193-2026More 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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