Stryker Sustainability Solutions: Catheter, Recording, Electrode, Reprocessed
Recall Summary Stryker Sustainability Solutions is recalling reprocessed BARD Dynamic Tip Steerable electrophysiology catheters (Product Number 200344) distributed nationwide in the US, as well as in Canada and Israel, because some sterile product packages have incomplete seals. The incomplete seals could allow contamination of the medical device. This is classified as a Class II recall, affecting healthcare facilities and patients who may have received these catheters.
- Recalling firm
- Stryker Sustainability Solutions
- Product
- BARD Dynamic Tip Steerable, Product Number 200344; 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/61fc8f6e-df28-4098-beef-56565900e58a