Warning
Stryker Sustainability Solutions Recalls CS Uni-Directional w Auto ID
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #Z-2185-2026Medical Device
Stryker Sustainability Solutions Recalls CS Uni-Directional w Auto ID
Stryker Sustainability Solutions · Class II — Moderate Risk
Product Description
CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Reason for Recall
Incomplete seals on sterile product
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
US Nationwide and the countries of Israel and Canada.
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
A Class II FDA recall has been issued for a medical device from Stryker Sustainability Solutions, initiated on April 10, 2026. Incomplete seals on sterile product. This recall covers 816 units, distributed internationally, including the United States. While not the highest severity, consumers should exercise caution and stop using the product until the recall is resolved.
Sources: FDA openFDA Enforcement Database
This recall appears in: Medical Device Defects and Stryker Sustainability Solutions recalls.