FDA-Device2026-05-20Class IIPACKAGING DEFECT
Stryker CS Uni-Directional electrophysiology catheter recalled for incomplete sterile seals
OTHERNationwide distribution
Stryker electrophysiology catheter recalled for seal defect
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
Hazard
Incomplete seals on sterile product
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 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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