FDA-Device2026-05-20Class IIPACKAGING DEFECT
Stryker BARD Dynamic XT Steerable electrophysiology catheter recalled for incomplete sterile seals
OTHERNationwide distribution
Stryker BARD Dynamic XT catheter recalled for incomplete sterile seals
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.
Hazard
Incomplete seals on sterile product
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 Sustainability Solutions recalls
- FDA-Device2026-05-20Stryker BARD Dynamic Tip Steerable catheter recalled for incomplete sterile seals
- FDA-Device2026-05-20Stryker BARD Dynamic Deca Steerable catheter recalled for incomplete sterile seals
- FDA-Device2026-05-20Stryker Daig Livewire Steerable catheter recalled for incomplete sterile seals
- FDA-Device2026-05-20Stryker BARD EP XT Decapolar Steerable catheters recalled for incomplete sterile seals
- FDA-Device2026-05-20Stryker Daig Livewire Steerable catheters recalled for incomplete sterile seals
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