Stryker Sustainability Solutions: Catheter, Recording, Electrode, Reprocessed
Stryker Sustainability Solutions is recalling reprocessed Daig Livewire Steerable electrophysiology catheters (Product Number 401915) distributed nationwide in the US, Canada, and Israel because some units have incomplete seals on their sterile packaging. This is a Class II recall, meaning the defective seals could potentially allow contamination that may cause serious health problems. The recall affects medical facilities that received these catheters.
- Recalling firm
- Stryker Sustainability Solutions
- Product
- Daig Livewire Steerable, Product Number 401915; 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/dcbd4be9-f51c-44ab-b0d5-d725e4cd6491