FDA-Device2026-05-20Class IIPACKAGING DEFECT
Stryker Daig Livewire Steerable electrophysiology catheter recalled for incomplete sterile seals
What this means
Stryker Sustainability Solutions recalled Daig Livewire Steerable electrophysiology catheters (Product Number 401914) due to incomplete seals on the sterile packaging. The defect affects 10 units across 10 lot numbers distributed in the US, Canada, and Israel. No injuries have been reported.
- Check if your facility has catheters matching Product Number 401914 and one of the affected lot numbers (3293805, 4060170, 4533158, 4613654, 4678077, 4846998, 4973532, 4976226, 5005455, 5056648).
- Do not use catheters with incomplete or damaged sterile seals.
- Contact Stryker for instructions on returning or replacing affected units.
The agency's original wording
Hazard
Incomplete seals on sterile product
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide and the countries of Israel and Canada.
Affected count
10 units
Manufactured in
1810 W Drake Dr, Tempe, AZ, United States
Products
Daig Livewire Steerable, Product Number 401914; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2194-2026More Stryker recalls
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