Stryker Sustainability Solutions: Catheter, Recording, Electrode, Reprocessed
Recall Summary Stryker Sustainability Solutions is recalling reprocessed Daig Livewire Steerable catheters (Product Number 401908) used in heart rhythm procedures due to incomplete seals on the sterile packaging. The affected catheters were distributed nationwide across all U.S. states and territories, as well as in Canada and Israel. This is a Class II recall, indicating a situation where use of the product could cause serious harm or death.
- Recalling firm
- Stryker Sustainability Solutions
- Product
- Daig Livewire Steerable, Product Number 401908; 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/b98b2271-7198-4a37-b3f7-42cb310fa92d