FDA-Device2026-05-20Class IIPACKAGING DEFECT
Stryker BARD Dynamic XT Steerable electrophysiology catheter recalled for incomplete sterile seals
Nationwide distributionMedical devices
What this means
Stryker Sustainability Solutions is recalling the BARD Dynamic XT Steerable electrophysiology catheter (Product Number 201103) due to incomplete seals on the sterile packaging. This defect could compromise the sterility of the device. The recall affects specific lot numbers distributed nationwide in the US, as well as in Israel and Canada.
- If you have this catheter, stop using it and contact Stryker immediately.
- Do not use any units from the affected lot numbers.
- Return the device to Stryker or your supplier for replacement or 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.
Manufactured in
1810 W Drake Dr, Tempe, AZ, United States
Products
BARD Dynamic XT Steerable, Product Number 201103, REPROCESSED ELECTROPHYSIOLOGY CATHETER
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2179-2026More Stryker recalls
- FDA-Device2026-09-23Ethicon XCEL Bladeless Trocar with OptiView recalled for reusable port cracking risk
- FDA-Device2026-09-23Ethicon XCEL Bladeless Trocar recalled for potential cracking or separation during use
- FDA-Device2026-09-23Ethicon Xcel Bladeless Trocar recalled for potential cracking or separation during surgery
- FDA-Device2026-09-23Ethicon Xcel Bladeless Trocar recalled for crack or separation risk during use
- FDA-Device2026-09-23Ethicon Endo-Surgery XCEL Bladeless Trocar recalled for cracking or separation during use
Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.