Stryker Sustainability Solutions: Catheter, Recording, Electrode, Reprocessed

Stryker Sustainability Solutions is recalling reprocessed BARD Dynamic Tip Steerable electrophysiology catheters (Product Number 200131) because some sterile packaging seals are incomplete, potentially allowing contamination. The affected catheters were distributed nationwide in the US, as well as in Canada and Israel. This is a Class II recall, meaning the product could cause serious adverse health effects or death.

Recalling firm
Stryker Sustainability Solutions
Product
BARD Dynamic Tip Steerable, Product Number 200131; 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/4ef50850-292a-48ed-9569-fb5d76666e8a