Stryker Sustainability Solutions: Catheter, Recording, Electrode, Reprocessed
Recall Summary Stryker Sustainability Solutions is recalling reprocessed BARD Dynamic Deca Steerable catheters (Product Number 201101) distributed nationwide in the US, Canada, and Israel because some units have incomplete seals on their sterile packaging. This is a Class II recall affecting electrophysiology catheters used in medical procedures. The incomplete seals could potentially allow sterility to be compromised.
- Recalling firm
- Stryker Sustainability Solutions
- Product
- BARD Dynamic Deca Steerable, Product Number 201101; 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/6ba4a612-3276-4ed6-9967-9a613b451335