FDA-Device2026-05-20Class IIPACKAGING DEFECT
Stryker Daig Livewire Steerable catheter recalled for incomplete sterile seals
Nationwide distributiondevice
Stryker Daig Livewire catheter recalled for incomplete sterile seals
Stryker Sustainability Solutions recalled certain reprocessed electrophysiology catheters (Daig Livewire Steerable, Product Number 401652) because the sterile packaging has incomplete seals. An incomplete seal can allow contamination to enter the package, compromising sterility before the device is used.
- If you have a device from the affected lot numbers, do not use it.
- Contact your healthcare facility's supply chain or sterile processing department to verify whether you have an affected unit.
- Return the device to Stryker for a replacement or refund.
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
24 units
Manufactured in
1810 W Drake Dr, Tempe, AZ, United States
Products
Daig Livewire Steerable, Product Number 401652; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2190-2026Don't want to check this manually?
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