Stryker Sustainability Solutions: Catheter, Recording, Electrode, Reprocessed
Recall Summary Stryker Sustainability Solutions is recalling reprocessed BARD EP XT Steerable catheters (Product Number 200794) used in heart rhythm procedures due to incomplete seals on the sterile packaging. The affected devices were distributed nationwide across the US, as well as in Canada and Israel. This is a Class II recall, indicating a potential health risk from the compromised sterile barrier.
- Recalling firm
- Stryker Sustainability Solutions
- Product
- BARD EP XT Steerable, Product Number 200794; 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/dce42b68-d8d6-4a45-80e2-a5b60e3cad63