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 identified incomplete seals on certain lots of the Daig Livewire Steerable reprocessed electrophysiology catheter (Product Number 401923). The affected units may not maintain sterility, which could pose a risk during use. Three units have been affected.
- Check your product for Lot Numbers 3557411, 3702628, or 4498116.
- If you have an affected unit, contact Stryker Sustainability Solutions or your supplier for instructions on return or replacement.
- Do not use affected catheters until you have received guidance from the manufacturer.
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
3 units
Manufactured in
1810 W Drake Dr, Tempe, AZ, United States
Products
Daig Livewire Steerable, Product Number 401923; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2196-2026More Stryker recalls
- FDA-Device2026-09-23Ethicon XCEL Bladeless Trocar with OptiView recalled for reusable port cracking risk
- FDA-Device2026-09-23Ethicon XCEL Bladeless Trocar recalled for potential cracking or separation during use
- FDA-Device2026-09-23Ethicon Xcel Bladeless Trocar recalled for potential cracking or separation during surgery
- FDA-Device2026-09-23Ethicon Xcel Bladeless Trocar recalled for crack or separation risk during use
- FDA-Device2026-09-23Ethicon Endo-Surgery XCEL Bladeless Trocar recalled for cracking or separation during use
Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.