FDA-Device2026-05-20Class IIPACKAGING DEFECT
Stryker CS Uni-Directional electrophysiology catheter recalled for incomplete sterile seals
What this means
Stryker Sustainability Solutions is recalling certain lots of CS Uni-Directional electrophysiology catheters (Product Number D135304) because some units have incomplete seals on their sterile packaging. An incomplete seal could allow the sterile catheter to become contaminated before use.
- If you have a catheter from one of the affected lot numbers, stop using it and contact your Stryker representative
- Check the product label or lot number against the full list provided by the FDA
- Do not use the device if the package seal appears damaged or incomplete
The agency's original wording
Hazard
Incomplete seals on sterile product
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide and the countries of Israel and Canada.
Affected count
816 units
Manufactured in
1810 W Drake Dr, Tempe, AZ, United States
Products
CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2185-2026More Stryker recalls
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