FDA-Device2026-05-20Class IIPACKAGING DEFECT
Stryker BARD EP XT Decapolar Steerable catheters recalled for incomplete sterile seals
Nationwide distributionMedical devices
What this means
Stryker Sustainability Solutions is recalling BARD EP XT Decapolar Steerable electrophysiology catheters (Product Number 201007) due to incomplete seals on the sterile packaging. The incomplete seals could allow contamination of the catheter before use. A total of 217 units across multiple lot numbers were distributed in the U.S., Israel, and Canada.
- Check if you have any units matching the affected lot numbers listed in the recall notice.
- Do not use affected catheters.
- Contact Stryker Sustainability Solutions or the FDA for instructions on return or disposal.
- Report any adverse events to the FDA MedWatch program.
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
217 units
Manufactured in
1810 W Drake Dr, Tempe, AZ, United States
Products
BARD EP XT Decapolar Steerable, Product Number 201007; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2181-2026More Stryker recalls
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