FDA-Device2026-05-20Class IIPACKAGING DEFECT
Stryker Daig Livewire Steerable BDB catheter recalled for incomplete sterile seals
Stryker Daig Livewire catheter recalled for incomplete sterile seals
Stryker Sustainability Solutions is recalling Daig Livewire Steerable BDB electrophysiology catheters (Product Number 401918) due to incomplete seals on the sterile packaging. This affects 2 units with specific lot numbers. Incomplete seals may allow contamination of the sterile product.
- Check your facility inventory for Product Number 401918, Lot Numbers 4101996 or 4175347.
- Do not use affected units.
- Contact Stryker Sustainability Solutions for return or replacement instructions.
Hazard
Incomplete seals on sterile product
Who it affects
Adults
Illnesses reported
None reported
Sold states
US Nationwide and the countries of Israel and Canada.
Affected count
2 units
Manufactured in
1810 W Drake Dr, Tempe, AZ, United States
Products
Daig Livewire Steerable BDB, Product Number 401918, REPROCESSED ELECTROPHYSIOLOGY CATHETER
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2198-2026Don't want to check this manually?
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