FDA-Device2026-05-20Class IIPACKAGING DEFECT
Stryker BARD Dynamic XT Steerable electrophysiology catheter recalled for incomplete sterile seals
What this means
Stryker Sustainability Solutions is recalling certain reprocessed BARD Dynamic XT Steerable electrophysiology catheters due to incomplete seals on the sterile packaging. The incomplete seals may allow contamination of the sterile product before use. This affects 5 units in the US, Canada, and Israel.
- If you have one of the affected lot numbers (4064760, 4336810, 4381356, 4381359, 4401919), stop using it and contact your healthcare facility or Stryker.
- Do not use any affected catheter for patient procedures.
- Return the product to Stryker for inspection or replacement.
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
5 units
Manufactured in
1810 W Drake Dr, Tempe, AZ, United States
Products
BARD Dynamic XT Steerable, Product Number 201104; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2180-2026More Stryker recalls
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