FDA-Device2026-05-20Class IIPACKAGING DEFECT
Stryker CS Uni-Directional electrophysiology catheter recalled for incomplete sterile seals
What this means
Stryker Sustainability Solutions' CS Uni-Directional w Auto ID electrophysiology catheter (Product Number D135303) has incomplete seals on some units, which could compromise sterility. The affected lots were distributed in the US, Canada, and Israel. No injuries have been reported.
- Check if your facility has inventory matching any of the affected lot numbers listed in the recall notice.
- Do not use affected units; quarantine them and contact Stryker if you have questions about your specific lots.
- Review your records to identify patients who may have received the device and consult with your medical team if needed.
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
449 units
Manufactured in
1810 W Drake Dr, Tempe, AZ, United States
Products
CS Uni-Directional w Auto ID, Product Number D135303; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2184-2026More Stryker recalls
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