FDA-Device2026-05-20Class IIPACKAGING DEFECT
Stryker Daig Livewire Steerable catheters recalled for incomplete sterile seals
Nationwide distributiondevice
Stryker Daig Livewire catheters recalled for incomplete seals
Stryker Sustainability Solutions recalled Daig Livewire Steerable electrophysiology catheters (Product Number 401581) because some units have incomplete seals on their sterile packaging. This affects 108 catheters distributed in the US, Canada, and Israel across multiple lot numbers.
- Check your facility's inventory for affected lot numbers (3683857, 3836878, 3981321, 4042778, 4053585, 4103495, 4496897, and 43 others listed in the recall notice).
- Do not use catheters with incomplete or compromised seals.
- Contact Stryker for instructions on return or replacement of affected units.
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
108 units
Manufactured in
1810 W Drake Dr, Tempe, AZ, United States
Products
Daig Livewire Steerable, Product Number 401581; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2187-2026Don't want to check this manually?
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