Stryker Sustainability Solutions: Catheter, Recording, Electrode, Reprocessed
Summary Stryker Sustainability Solutions is recalling reprocessed Daig Livewire Steerable electrophysiology catheters (Product Number 401575) due to incomplete seals on the sterile packaging. The affected catheters were distributed nationwide across the U.S., 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 401575; 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/283ae91e-bac1-411a-aa6b-a640b5a74741