FDA-Device2026-05-20Class IIPACKAGING DEFECT
Stryker Daig Livewire Steerable catheter recalled for incomplete sterile seals
Nationwide distributionMedical devices
What this means
Stryker Sustainability Solutions is recalling certain lots of the Daig Livewire Steerable electrophysiology catheter because some units have incomplete seals on their sterile packaging. This affects 107 catheters distributed in the U.S., Canada, and Israel. No injuries have been reported.
- Check if you have a catheter matching any of the listed lot numbers.
- If you do, contact Stryker or your medical facility for replacement instructions.
- Do not use 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
107 units
Manufactured in
1810 W Drake Dr, Tempe, AZ, United States
Products
Daig Livewire Steerable, Product Number 401905; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2192-2026More Stryker recalls
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