Stryker Sustainability Solutions: Catheter, Recording, Electrode, Reprocessed
Stryker Sustainability Solutions is recalling reprocessed Daig Livewire Steerable catheters (Product Number 401905) used in electrophysiology procedures because some units have incomplete seals on their sterile packaging. The recall affects products distributed nationwide across the US, as well as in Canada and Israel. This is a Class II recall, meaning the product could cause serious adverse health consequences or death.
- Recalling firm
- Stryker Sustainability Solutions
- Product
- Daig Livewire Steerable, Product Number 401905; 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/65b7abe2-6bcd-40ac-af35-2f41df5d619f