FDA-Device2026-05-20Class IIPACKAGING DEFECT
Stryker Daig Livewire Steerable electrophysiology catheter recalled for incomplete sterile seals
What this means
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.
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
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 recalls
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