Stryker Sustainability Solutions: Catheter, Recording, Electrode, Reprocessed
Stryker Sustainability Solutions is recalling reprocessed Daig Livewire Steerable catheters (Product Number 401652) used in heart rhythm procedures because some units have incomplete seals on their sterile packaging. The affected devices were distributed nationwide in the US, as well as in Canada and Israel. This is classified as a Class II recall, meaning the defect could cause adverse health effects but is unlikely to result in serious injury.
- Recalling firm
- Stryker Sustainability Solutions
- Product
- Daig Livewire Steerable, Product Number 401652; 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/087cf03c-8e0e-43dc-bc45-74e817563f1d