Stryker Sustainability Solutions: Catheter, Recording, Electrode, Reprocessed
Stryker Sustainability Solutions is recalling reprocessed electrophysiology catheters (CS Uni-Directional w Auto ID, Product Number D135304) because some units have incomplete seals on their sterile packaging. The affected catheters were distributed nationwide across the US, as well as in Canada and Israel. This is classified as a Class II recall, meaning the product could cause adverse health effects but is unlikely to cause serious injury.
- Recalling firm
- Stryker Sustainability Solutions
- Product
- CS Uni-Directional w Auto ID, Product Number D135304; 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/72c7eb4e-8c58-4244-9148-98ec551547cd