FDA-Device2026-05-20Class IIPACKAGING DEFECT
Stryker BW Webster Duo-Decapolar electrophysiology catheter recalled for incomplete sterile seals
What this means
Stryker Sustainability Solutions is recalling certain lots of the BW Webster Duo-Decapolar reprocessed electrophysiology catheter due to incomplete seals on the sterile packaging. The incomplete seals could allow contamination of the sterile product before use. A total of 154 units were affected across the US, Canada, and Israel.
- Check if you have any of the affected lot numbers listed in this recall.
- Do not use any affected catheters.
- Contact Stryker or your supplier with questions about replacement or return instructions.
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
154 units
Manufactured in
1810 W Drake Dr, Tempe, AZ, United States
Products
BW Webster Duo-Decapolar, Product Number D728260RT; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2183-2026More Stryker recalls
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