Stryker Sustainability Solutions: Catheter, Recording, Electrode, Reprocessed
Stryker Sustainability Solutions is recalling reprocessed Daig Livewire Steerable electrophysiology catheters (Product Number 401918) because some units have incomplete seals on their sterile packaging. The affected catheters were distributed nationwide across the U.S., as well as in Canada and Israel. This is classified as a Class II recall, meaning the product could potentially cause adverse health effects.
- Recalling firm
- Stryker Sustainability Solutions
- Product
- Daig Livewire Steerable BDB, Product Number 401918, 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/3ccec1ac-3c3c-4d38-a207-580a080c50ce