Stryker Sustainability Solutions: Catheter, Recording, Electrode, Reprocessed
Recall Summary Stryker Sustainability Solutions is recalling Daig Livewire Steerable reprocessed electrophysiology catheters (Product Number 401914) distributed nationwide in the US, as well as in Canada and Israel, because some units have incomplete seals on their sterile packaging. This is a Class II recall, meaning the defect could potentially cause serious health consequences. The affected catheters were distributed across all US states.
- Recalling firm
- Stryker Sustainability Solutions
- Product
- Daig Livewire Steerable, Product Number 401914; 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/225b46e4-28f5-44d8-9dde-dd1c42cabcd9