FDA-Device2026-05-20Class IIPACKAGING DEFECT
Stryker Daig Livewire Steerable electrophysiology catheter recalled for incomplete sterile seals
OTHERNationwide distribution
Stryker Daig Livewire catheter recalled for incomplete sterile seals
Stryker Sustainability Solutions identified incomplete seals on sterile packaging for certain Daig Livewire Steerable electrophysiology catheters. This affects 9 units distributed in the US, Canada, and Israel. No injuries have been reported.
- Check if you have product number 401603 with one of the affected lot numbers: 3978113, 4465650, 4468623, 4594989, 4622932, 4622934, 4629627, 4665006, or 4720693.
- Contact Stryker or your distributor for instructions on returning or replacing affected units.
- Do not use catheters with incomplete seals.
Hazard
Incomplete seals on sterile product
Sold states
US Nationwide and the countries of Israel and Canada.
Affected count
9 units
Manufactured in
1810 W Drake Dr, Tempe, AZ, United States
Products
Daig Livewire Steerable, Product Number 401603, REPROCESSED ELECTROPHYSIOLOGY CATHETER
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2189-2026More 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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