Stryker Sustainability Solutions: Catheter, Recording, Electrode, Reprocessed

Recall Summary Stryker Sustainability Solutions is recalling reprocessed BARD Dynamic XT Steerable electrophysiology catheters (Product Number 201103) distributed across the US, 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 adverse health effects. The affected catheters were distributed nationwide to all 50 states plus Washington, DC.

Recalling firm
Stryker Sustainability Solutions
Product
BARD Dynamic XT Steerable, Product Number 201103, 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/1391544c-b7db-42fb-aec8-5b8f2a771b0d