FDA-Device2026-05-20Class IIPACKAGING DEFECT
Stryker BARD EP XT Steerable catheter recalled for incomplete sterile seals
Nationwide distributionMedical devices
What this means
Stryker Sustainability Solutions is recalling BARD EP XT Steerable electrophysiology catheters (Product Number 200794) due to incomplete seals on the sterile packaging. The incomplete seals could allow contamination of the sterile device before use. A total of 44 units across multiple lot numbers have been affected.
- Check if your facility received any of the affected lot numbers listed in this recall.
- Do not use any affected catheters.
- Contact Stryker Sustainability Solutions for instructions on return or replacement of affected units.
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
44 units
Manufactured in
1810 W Drake Dr, Tempe, AZ, United States
Products
BARD EP XT Steerable, Product Number 200794; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2182-2026More Stryker recalls
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