FDA-Device2026-05-20Class IIPACKAGING DEFECT
Stryker CS Uni-Directional electrophysiology catheter recalled for incomplete sterile seals
OTHERNationwide distribution
Stryker electrophysiology catheter recalled for incomplete sterile seals
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.
Hazard
Incomplete seals on sterile product
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 Sustainability Solutions recalls
- FDA-Device2026-05-20Stryker BARD Dynamic Tip Steerable catheter recalled for incomplete sterile seals
- FDA-Device2026-05-20Stryker BARD Dynamic Deca Steerable catheter recalled for incomplete sterile seals
- FDA-Device2026-05-20Stryker Daig Livewire Steerable catheter recalled for incomplete sterile seals
- FDA-Device2026-05-20Stryker BARD EP XT Decapolar Steerable catheters recalled for incomplete sterile seals
- FDA-Device2026-05-20Stryker Daig Livewire Steerable catheters recalled for incomplete sterile seals
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