Stryker Sustainability Solutions: Catheter, Recording, Electrode, Reprocessed

Stryker Sustainability Solutions is recalling reprocessed Daig Livewire Steerable catheters (Product Number 401904) distributed nationwide in the US, as well as in Canada and Israel, because some units have incomplete seals on their sterile packaging. These catheters are medical devices used in electrophysiology procedures. The incomplete seals could potentially compromise the sterility of the product.

Recalling firm
Stryker Sustainability Solutions
Product
Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Reason
Incomplete seals on sterile product
Classification
Class II
Category
medical device recall
Country
United States
Agency
FDA-DEVICES
Recall date
2026-04-10
Status
Open, Classified
Areas affected
AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
Distribution
US Nationwide and the countries of Israel and Canada.

Official recall notice from FDA-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/e11dcf09-c060-426c-87a3-ce7762307fb4