FDA-Device2026-05-20Class IIPACKAGING DEFECT
Stryker BARD Dynamic XT Deca Steerable catheters recalled for incomplete sterile seals
What this means
Stryker Sustainability Solutions is recalling BARD Dynamic XT Deca Steerable electrophysiology catheters (Product Number 201102) due to incomplete seals on the sterile packaging. The defect affects 90 units across multiple lot numbers distributed in the US, Canada, and Israel. No injuries have been reported.
- Check if your facility received any of the affected lot numbers listed in the recall notice.
- Do not use affected catheters; contact Stryker Sustainability Solutions for return or replacement instructions.
- Verify the product lot number before each use going forward.
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
90 units
Manufactured in
1810 W Drake Dr, Tempe, AZ, United States
Products
BARD Dynamic XT Deca Steerable, Product Number 201102, REPROCESSED ELECTROPHYSIOLOGY CATHETER
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2178-2026More Stryker recalls
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