Class II

Medical Device Recall: CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Stryker Sustainability Solutions · April 10, 2026

Reason for Recall

Incomplete seals on sterile product

Distribution

US Nationwide and the countries of Israel and Canada.

States Affected

NATIONWIDE

Quantity Affected

816 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2185-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Stryker Sustainability Solutions Medical Device Recall: CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER | SafeCheck